메뉴 건너뛰기




Volumn , Issue , 2015, Pages 1-328

Fundamental Concepts for New Clinical Trialists

Author keywords

[No Author keywords available]

Indexed keywords


EID: 85123139668     PISSN: None     EISSN: None     Source Type: Book    
DOI: None     Document Type: Book
Times cited : (12)

References (296)
  • 1
    • 84860444921 scopus 로고    scopus 로고
    • Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010
    • Califf RM, Zarin DA, Kramer JM, Sherman RE, Aberle LH, Tasneem A. 2012. Characteristics of clinical trials registered in ClinicalTrials.gov, 2007-2010. JAMA 307(17): 1838-1847.
    • (2012) JAMA , vol.307 , Issue.17 , pp. 1838-1847
    • Califf, R.M.1    Zarin, D.A.2    Kramer, J.M.3    Sherman, R.E.4    Aberle, L.H.5    Tasneem, A.6
  • 2
    • 67649573353 scopus 로고    scopus 로고
    • March, Food and Drug Administration
    • Challenge and Opportunity on the Critical Path to New Medicinal Products. March 2004. U.S. Department of Health and Human Services. Food and Drug Administration.
    • (2004) U.S. Department of Health and Human Services
  • 3
    • 84860458009 scopus 로고    scopus 로고
    • The evolution of trail registries and their use to assess the clinical trial enterprise
    • Dickerson K, Rennie D. 2012. The evolution of trail registries and their use to assess the clinical trial enterprise. JAMA 307(17): 1861-1864.
    • (2012) JAMA , vol.307 , Issue.17 , pp. 1861-1864
    • Dickerson, K.1    Rennie, D.2
  • 7
    • 80051757887 scopus 로고    scopus 로고
    • Compendium of unpublished phase III trials in oncology: Characteristics and impact on clinical practice
    • Tam VC, Tannock IF, Massey C, Rauw J, Kryzyzanowska MK. 2011. Compendium of unpublished phase III trials in oncology: Characteristics and impact on clinical practice. J Clin Oncol 29(23): 3133-3139.
    • (2011) J Clin Oncol , vol.29 , Issue.23 , pp. 3133-3139
    • Tam, V.C.1    Tannock, I.F.2    Massey, C.3    Rauw, J.4    Kryzyzanowska, M.K.5
  • 11
    • 85123159987 scopus 로고    scopus 로고
    • Lipitor Prescribing Information. 2005. http://www.lipitor.com/content/LipitorPI.pdf.
    • (2005)
  • 12
    • 0028945355 scopus 로고
    • Dose-response studies I. Some design considerations
    • Ruberg SJ. 1995. Dose-response studies I. Some design considerations. J Biopharm Stat 5(1): 1-14.
    • (1995) J Biopharm Stat , vol.5 , Issue.1 , pp. 1-14
    • Ruberg, S.J.1
  • 17
    • 85123160002 scopus 로고    scopus 로고
    • (FACA, Public Law 92-463)
    • Federal Advisory Committee Act (FACA, Public Law 92-463).
  • 18
    • 0029920061 scopus 로고    scopus 로고
    • On-the-job training of pharmaceutical statisticians
    • Chuang-Stein C. 1996. On-the-job training of pharmaceutical statisticians. Drug Inf J 30: 351-357.
    • (1996) Drug Inf J , vol.30 , pp. 351-357
    • Chuang-Stein, C.1
  • 19
    • 1142294873 scopus 로고    scopus 로고
    • Pharmaceutical statisticians in the U.S.: Our future and our direction
    • Chuang-Stein C. 1999. Pharmaceutical statisticians in the U.S.: Our future and our direction. Biopharm Rep 7(3): 1-5.
    • (1999) Biopharm Rep , vol.7 , Issue.3 , pp. 1-5
    • Chuang-Stein, C.1
  • 20
    • 85123144926 scopus 로고    scopus 로고
    • Cultivating non-technical skills of pharmaceutical statisticians
    • Chuang-Stein C. 2005. Cultivating non-technical skills of pharmaceutical statisticians. Biopharm Rep 13(2): 1-4.
    • (2005) Biopharm Rep , vol.13 , Issue.2 , pp. 1-4
    • Chuang-Stein, C.1
  • 21
    • 35148837791 scopus 로고    scopus 로고
    • Some comments on improving collaboration skills of the statistician on a drug development team
    • Johnson JR. 2007. Some comments on improving collaboration skills of the statistician on a drug development team. Drug Inf J 41(5): 629-632.
    • (2007) Drug Inf J , vol.41 , Issue.5 , pp. 629-632
    • Johnson, J.R.1
  • 22
    • 0033038777 scopus 로고    scopus 로고
    • Guidelines for assessing the performance of statisticians involved in clinical research in the pharmaceutical industry
    • Phillips A. 1999. Guidelines for assessing the performance of statisticians involved in clinical research in the pharmaceutical industry. Drug Inf J 33: 427-433.
    • (1999) Drug Inf J , vol.33 , pp. 427-433
    • Phillips, A.1
  • 23
    • 33750085007 scopus 로고    scopus 로고
    • Biostatisticians, biostatistical science and the future
    • Zelen M. 2006. Biostatisticians, biostatistical science and the future. Stat Med 25: 3409-3414.
    • (2006) Stat Med , vol.25 , pp. 3409-3414
    • Zelen, M.1
  • 24
    • 77649138513 scopus 로고    scopus 로고
    • Conditioned pharmacotherapeutic effects: A preliminary study
    • Ader R et al. 2010. Conditioned pharmacotherapeutic effects: A preliminary study. Psychosom Med 72: 192-197.
    • (2010) Psychosom Med , vol.72 , pp. 192-197
    • Ader, R.1
  • 25
    • 84903817449 scopus 로고    scopus 로고
    • Sample size determination in group-sequential clinical trials with two co-primary endpoints
    • Asakura K, Hamasaki T, Sugimoto T, Hayashi K, Evans SR, Sozu T. 2014. Sample size determination in group-sequential clinical trials with two co-primary endpoints. Stat Med 33: 2897-2913.
    • (2014) Stat Med , vol.33 , pp. 2897-2913
    • Asakura, K.1    Hamasaki, T.2    Sugimoto, T.3    Hayashi, K.4    Evans, S.R.5    Sozu, T.6
  • 26
    • 0031438949 scopus 로고    scopus 로고
    • Validation study of a computerized version of the Western Ontario and McMaster Universities VA 3.0 Osteoarthritis Index
    • Bellamy N, Campbell J, Stevens J, Pilch L, Stewart C, Mahmood Z. 1997. Validation study of a computerized version of the Western Ontario and McMaster Universities VA 3.0 Osteoarthritis Index. J Rheumatol 24: 2413-2415.
    • (1997) J Rheumatol , vol.24 , pp. 2413-2415
    • Bellamy, N.1    Campbell, J.2    Stevens, J.3    Pilch, L.4    Stewart, C.5    Mahmood, Z.6
  • 27
    • 84904914792 scopus 로고    scopus 로고
    • The role of statistics in medical devices-The contrast with pharmaceuticals
    • Campbell G. 2006. The role of statistics in medical devices-The contrast with pharmaceuticals. Biopharmaceut Rep 14: 1.
    • (2006) Biopharmaceut Rep , vol.14 , pp. 1
    • Campbell, G.1
  • 28
    • 0034662961 scopus 로고    scopus 로고
    • Lessons learned from attempts to establish the blind in placebo-controlled trials of zinc for the common cold
    • Desbiens NA. 2000. Lessons learned from attempts to establish the blind in placebo-controlled trials of zinc for the common cold. Ann Intern Med 133(4): 302-303.
    • (2000) Ann Intern Med , vol.133 , Issue.4 , pp. 302-303
    • Desbiens, N.A.1
  • 29
    • 0021632262 scopus 로고
    • Approaches to sample size estimation in the design of clinical trials-A review
    • Donner A. 1984. Approaches to sample size estimation in the design of clinical trials-A review. Stat Med 3: 199-214.
    • (1984) Stat Med , vol.3 , pp. 199-214
    • Donner, A.1
  • 30
    • 0034687076 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 2)
    • Ellenberg SS, Temple R. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 2). Ann Intern Med 133(6): 464-470.
    • (2000) Ann Intern Med , vol.133 , Issue.6 , pp. 464-470
    • Ellenberg, S.S.1    Temple, R.2
  • 31
    • 84903836051 scopus 로고    scopus 로고
    • A randomized trial evaluating Prosaptide™ for HIV-associated sensory neuropathies: Use of an electronic diary to record neuropathic pain
    • Evans SR et al. 2007. A randomized trial evaluating Prosaptide™ for HIV-associated sensory neuropathies: Use of an electronic diary to record neuropathic pain. PLoS ONE, 2(7): e551. doi: 10.1371/journal.pone.0000551.
    • (2007) PLoS ONE , vol.2 , Issue.7 , pp. e551
    • Evans, S.R.1
  • 33
    • 0345424863 scopus 로고    scopus 로고
    • Irritable Bowel Syndrome: Clinical Evaluation of Products for Treatment, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, 2012
    • Food and Drug Administration. 2012. Guidance for Industry. Irritable Bowel Syndrome: Clinical Evaluation of Products for Treatment, Center for Drug Evaluation and Research, Food and Drug Administration, Rockville, MD, 2012.
    • (2012) Guidance for Industry
  • 34
    • 34247503838 scopus 로고    scopus 로고
    • Problems with use of composite endpoints in cardiovascular trials: Aystematic review of randomized trials
    • Ferreira-Gonzalez I et al. 2007. Problems with use of composite endpoints in cardiovascular trials: Aystematic review of randomized trials. BMJ 334: 786.
    • (2007) BMJ , vol.334 , pp. 786
    • Ferreira-Gonzalez, I.1
  • 35
    • 76749169724 scopus 로고    scopus 로고
    • Biological, clinical, and ethical advances of placebo effects
    • Finniss DG, Kaptchuk TJ, Miller F, Benedetti F. 2010. Biological, clinical, and ethical advances of placebo effects. Lancet 375: 686-695.
    • (2010) Lancet , vol.375 , pp. 686-695
    • Finniss, D.G.1    Kaptchuk, T.J.2    Miller, F.3    Benedetti, F.4
  • 36
    • 0037872688 scopus 로고    scopus 로고
    • Composite outcomes in randomized trials
    • Freemantle N et al. 2003. Composite outcomes in randomized trials. JAMA 289(19): 2554-2559.
    • (2003) JAMA , vol.289 , Issue.19 , pp. 2554-2559
    • Freemantle, N.1
  • 37
    • 0038242951 scopus 로고    scopus 로고
    • Itraconazole to prevent fungal infections in chronic granulomatous disease
    • Gallin JI et al. 2003. Itraconazole to prevent fungal infections in chronic granulomatous disease. NEJM 348: 2416-2422.
    • (2003) NEJM , vol.348 , pp. 2416-2422
    • Gallin, J.I.1
  • 38
    • 0021745695 scopus 로고
    • The evaluation of therapies: Historical control studies
    • Gehan EA. 1984. The evaluation of therapies: Historical control studies. Stat Med 3: 315-324.
    • (1984) Stat Med , vol.3 , pp. 315-324
    • Gehan, E.A.1
  • 40
    • 0031741255 scopus 로고    scopus 로고
    • Designing clinical trials to study rare disease treatment
    • Haffner ME. 1998. Designing clinical trials to study rare disease treatment. Drug Inf J 32: 957-960.
    • (1998) Drug Inf J , vol.32 , pp. 957-960
    • Haffner, M.E.1
  • 41
    • 84925248994 scopus 로고    scopus 로고
    • Group-sequential strategies in clinical trials with multiple co-primary outcomes
    • Hamasaki T, Asakura K, Evans SR, Sugimoto T, Suzo T. 2015. Group-sequential strategies in clinical trials with multiple co-primary outcomes. Stat Biopharm Res 7(1): 1-19.
    • (2015) Stat Biopharm Res , vol.7 , Issue.1 , pp. 1-19
    • Hamasaki, T.1    Asakura, K.2    Evans, S.R.3    Sugimoto, T.4    Suzo, T.5
  • 42
    • 84872494740 scopus 로고    scopus 로고
    • Sample size determination for clinical trials with co-primary outcomes: Exponential event-times
    • Hamasaki T, Sugimoto T, Evans SR, Sozu T. 2013. Sample size determination for clinical trials with co-primary outcomes: Exponential event-times. Pharm Stat 12: 28-34.
    • (2013) Pharm Stat , vol.12 , pp. 28-34
    • Hamasaki, T.1    Sugimoto, T.2    Evans, S.R.3    Sozu, T.4
  • 43
    • 0342902205 scopus 로고    scopus 로고
    • Is the placebo powerless?
    • Hrobjartsson A, Gotzsche PC. 2001. Is the placebo powerless? NEJM 344(21): 1594-1602.
    • (2001) NEJM , vol.344 , Issue.21 , pp. 1594-1602
    • Hrobjartsson, A.1    Gotzsche, P.C.2
  • 45
    • 2442678626 scopus 로고    scopus 로고
    • February, Statistical Principles for Clinical Trials
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. February 1998. ICH Harmonised Tripartite Guideline. Statistical Principles for Clinical Trials. E9.
    • (1998) ICH Harmonised Tripartite Guideline , pp. E9
  • 46
    • 43249121870 scopus 로고    scopus 로고
    • Components of placebo effect: Randomised controlled trial in patients with irritable bowel syndrome
    • Kaptchuk TJ et al. 2008. Components of placebo effect: Randomised controlled trial in patients with irritable bowel syndrome. BMJ 336(7651): 999-1003.
    • (2008) BMJ , vol.336 , Issue.7651 , pp. 999-1003
    • Kaptchuk, T.J.1
  • 47
    • 78650988467 scopus 로고    scopus 로고
    • Placebos without deception: A randomized controlled trial in irritable bowel syndrome
    • Kaptchuk TJ et al. 2010. Placebos without deception: A randomized controlled trial in irritable bowel syndrome. PLoS One 5(12): e15591.
    • (2010) PLoS One , vol.5 , Issue.12 , pp. e15591
    • Kaptchuk, T.J.1
  • 48
    • 0019362251 scopus 로고
    • Introduction to sample size determination and power analysis for clinical trials
    • Lachin JM. 1981. Introduction to sample size determination and power analysis for clinical trials. Controlled Clin Trials 2: 93-113.
    • (1981) Controlled Clin Trials , vol.2 , pp. 93-113
    • Lachin, J.M.1
  • 49
    • 0037905488 scopus 로고    scopus 로고
    • Clinical trials and rare diseases
    • Lagakos SW. 2003. Clinical trials and rare diseases. NEJM 348(24): 2455-2456.
    • (2003) NEJM , vol.348 , Issue.24 , pp. 2455-2456
    • Lagakos, S.W.1
  • 50
    • 84867183673 scopus 로고    scopus 로고
    • The prevention and treatment of missing data
    • Little et al. 2012. The prevention and treatment of missing data. NEJM 367(14): 1355-1360.
    • (2012) NEJM , vol.367 , Issue.14 , pp. 1355-1360
    • Little1
  • 51
    • 0037108042 scopus 로고    scopus 로고
    • Combined endpoints: Can we use them?
    • Lubsen J, Kirwan BA. 2002. Combined endpoints: Can we use them? Stat Med 21: 2959-2970.
    • (2002) Stat Med , vol.21 , pp. 2959-2970
    • Lubsen, J.1    Kirwan, B.A.2
  • 53
    • 20144373791 scopus 로고    scopus 로고
    • Validity of composite endpoints in clinical trials
    • Montori VM et al. 2005. Validity of composite endpoints in clinical trials. BMJ 330: 594-596.
    • (2005) BMJ , vol.330 , pp. 594-596
    • Montori, V.M.1
  • 55
    • 26844517347 scopus 로고    scopus 로고
    • Key issues in end point selection for heart failure trials: Composite endpoints
    • Neaton J et al. 2005. Key issues in end point selection for heart failure trials: Composite endpoints. J Card Fail 11(8): 567-575.
    • (2005) J Card Fail , vol.11 , Issue.8 , pp. 567-575
    • Neaton, J.1
  • 56
    • 0028091401 scopus 로고
    • The impact of blinding on the results of a randomized placebo-controlled multiple sclerosis clinical trial
    • Noseworthy JH, Ebers GC, Vandervoort MK, Farguhar RE, Yetisir E, Roberts R. 1994. The impact of blinding on the results of a randomized placebo-controlled multiple sclerosis clinical trial. Neurology 44(1): 16-20.
    • (1994) Neurology , vol.44 , Issue.1 , pp. 16-20
    • Noseworthy, J.H.1    Ebers, G.C.2    Vandervoort, M.K.3    Farguhar, R.E.4    Yetisir, E.5    Roberts, R.6
  • 57
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical tirals: Definitions and operational criteria
    • Prentice RL. 1989. Surrogate endpoints in clinical tirals: Definitions and operational criteria. Statistics in Medicine 8(4): 431-440.
    • (1989) Statistics in Medicine , vol.8 , Issue.4 , pp. 431-440
    • Prentice, R.L.1
  • 59
    • 0020045659 scopus 로고
    • Randomized versus historical controls for clinical trials
    • Sacks H, Chalmers TC, Smith H. 1982. Randomized versus historical controls for clinical trials. Am J Med 72: 233-240.
    • (1982) Am J Med , vol.72 , pp. 233-240
    • Sacks, H.1    Chalmers, T.C.2    Smith, H.3
  • 60
    • 33745928735 scopus 로고    scopus 로고
    • A meta-analysis of the association between adherence to drug therapy and mortality
    • Simpson SH et al. 2006. A meta-analysis of the association between adherence to drug therapy and mortality. BMJ 333(7557): 15.
    • (2006) BMJ , vol.333 , Issue.7557 , pp. 15
    • Simpson, S.H.1
  • 62
    • 84879101578 scopus 로고    scopus 로고
    • A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints
    • Sugimoto T, Sozu T, Hamasaki T, Evans SR. 2013. A logrank test-based method for sizing clinical trials with two co-primary time-to-event endpoints. Biostatistics 14(3): 409-421. doi: 10.1093/biostatistics/kxs057.
    • (2013) Biostatistics , vol.14 , Issue.3 , pp. 409-421
    • Sugimoto, T.1    Sozu, T.2    Hamasaki, T.3    Evans, S.R.4
  • 63
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 1)
    • Temple R, Ellenberg SS. 2000. Placebo-controlled trials and active-control trials in the evaluation of new treatments (Part 1). Ann Intern Med 133(6): 455-463.
    • (2000) Ann Intern Med , vol.133 , Issue.6 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 64
    • 77950188367 scopus 로고    scopus 로고
    • Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: A cluster-randomized controlled trial
    • Tripathy P et al. 2010. Effect of a participatory intervention with women’s groups on birth outcomes and maternal depression in Jharkhand and Orissa, India: A cluster-randomized controlled trial. Lancet 375: 1182-1192.
    • (2010) Lancet , vol.375 , pp. 1182-1192
    • Tripathy, P.1
  • 65
    • 79960230129 scopus 로고    scopus 로고
    • Active Albuterol or placebo, sham acupuncture, or no intervention in asthma
    • Wechsler ME et al. 2011. Active Albuterol or placebo, sham acupuncture, or no intervention in asthma. NEJM 365(2): 119-126.
    • (2011) NEJM , vol.365 , Issue.2 , pp. 119-126
    • Wechsler, M.E.1
  • 66
    • 0000058049 scopus 로고
    • The application of an urn model in controlled clinical trials
    • Wei LJ. 1978. The application of an urn model in controlled clinical trials. J Am Stat Assoc 73: 559-563.
    • (1978) J Am Stat Assoc , vol.73 , pp. 559-563
    • Wei, L.J.1
  • 67
    • 84950622103 scopus 로고
    • The randomized “play-the-winner” rule
    • Wei LJ, Durham S. 1978. The randomized “play-the-winner” rule. J Am Stat Assoc 73: 840-843.
    • (1978) J Am Stat Assoc , vol.73 , pp. 840-843
    • Wei, L.J.1    Durham, S.2
  • 68
    • 84970602731 scopus 로고
    • Experimental designs balanced for the estimation of residual effects of treatments
    • Williams EJ. 1949. Experimental designs balanced for the estimation of residual effects of treatments. Australian Journal of Scientific Research 2(3): 149-168.
    • (1949) Australian Journal of Scientific Research , vol.2 , Issue.3 , pp. 149-168
    • Williams, E.J.1
  • 69
    • 0030604427 scopus 로고    scopus 로고
    • Tutorial in biostatistics: Designing studies for dose response
    • Wong WK, Lachenbruch PA. 1996. Tutorial in biostatistics: Designing studies for dose response. Stat Med 15: 343-359.
    • (1996) Stat Med , vol.15 , pp. 343-359
    • Wong, W.K.1    Lachenbruch, P.A.2
  • 70
    • 0029857119 scopus 로고    scopus 로고
    • Play the winner for phase II/III clinical trials (Disc: P2455-2458)
    • Yao Q, Wei LJ. 1996. Play the winner for phase II/III clinical trials (Disc: p2455-2458). Stat Med 15: 2413-2423.
    • (1996) Stat Med , vol.15 , pp. 2413-2423
    • Yao, Q.1    Wei, L.J.2
  • 71
    • 0024988106 scopus 로고
    • Consideration of individual bioequivalence
    • Anderson S, Hauck WW. 1990. Consideration of individual bioequivalence. J Pharmacokinet Biopharm 18: 259-273.
    • (1990) J Pharmacokinet Biopharm , vol.18 , pp. 259-273
    • Anderson, S.1    Hauck, W.W.2
  • 72
    • 0035100888 scopus 로고    scopus 로고
    • Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework
    • Biomarkers Definition Working Group. 2001. Biomarkers and surrogate endpoints: Preferred definitions and conceptual framework. Clin Pharmacol Ther 69(3): 89-95.
    • (2001) Clin Pharmacol Ther , vol.69 , Issue.3 , pp. 89-95
  • 73
    • 0037160928 scopus 로고    scopus 로고
    • Use of ramipril in preventing stroke: Double-blind randomized trial
    • Bosch J et al. 2002. Use of ramipril in preventing stroke: Double-blind randomized trial. BMJ 324: 1-5, 699-702.
    • (2002) BMJ , vol.324
    • Bosch, J.1
  • 74
    • 33846850154 scopus 로고    scopus 로고
    • Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy
    • Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke H.-J, and for the Levetiracetam Monotherapy Study Group. 2007. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology 68(6): 402-408.
    • (2007) Neurology , vol.68 , Issue.6 , pp. 402-408
    • Brodie, M.J.1    Perucca, E.2    Ryvlin, P.3    Ben-Menachem, E.4    Meencke, H.-J.5
  • 75
    • 0025784574 scopus 로고
    • Issues in the early termination of the aspirin component of the physicians’ health study. Data monitoring board of the physicians’ health study
    • Cairns J et al. 1991. Issues in the early termination of the aspirin component of the physicians’ health study. Data monitoring board of the physicians’ health study. Ann Epidemiol 1: 395-405.
    • (1991) Ann Epidemiol , vol.1 , pp. 395-405
    • Cairns, J.1
  • 76
    • 0031030620 scopus 로고    scopus 로고
    • The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary artery bypass grafts. The post artery bypass graft trial investigators
    • Campeau L, Knatterud GL, Domanski M, Hunninghake DV, White CW, Geller NL, Rosenberg Y. 1997. The effect of aggressive lowering of low-density lipoprotein cholesterol levels and low-dose anticoagulation on obstructive changes in saphenous-vein coronary artery bypass grafts. The post artery bypass graft trial investigators. N Engl J Med 336: 153-162.
    • (1997) N Engl J Med , vol.336 , pp. 153-162
    • Campeau, L.1    Knatterud, G.L.2    Domanski, M.3    Hunninghake, D.V.4    White, C.W.5    Geller, N.L.6    Rosenberg, Y.7
  • 77
    • 2442692780 scopus 로고    scopus 로고
    • Empirical evidence for selective reporting of outcomes in randomized trials
    • Chan AW, Hrobjartsson A, Haahr MT, Gotzsche PC, Altman DG. 2004a. Empirical evidence for selective reporting of outcomes in randomized trials. JAMA 291: 2457-2465.
    • (2004) JAMA , vol.291 , pp. 2457-2465
    • Chan, A.W.1    Hrobjartsson, A.2    Haahr, M.T.3    Gotzsche, P.C.4    Altman, D.G.5
  • 78
    • 4844223081 scopus 로고    scopus 로고
    • Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research
    • Chan AW, Krleza-Jeric K, Schmid I, Altman DG. 2004b. Outcome reporting bias in randomized trials funded by the Canadian Institutes of Health Research. Can Med Assoc J 171: 735-740.
    • (2004) Can Med Assoc J , vol.171 , pp. 735-740
    • Chan, A.W.1    Krleza-Jeric, K.2    Schmid, I.3    Altman, D.G.4
  • 80
    • 0037472837 scopus 로고    scopus 로고
    • Non-inferiority trials: Design concepts and issues-The encounters of academic consultants in statistics
    • D’Agostino RB et al. 2003. Non-inferiority trials: Design concepts and issues-The encounters of academic consultants in statistics. Stat. Med. 22(2): 169-186.
    • (2003) Stat. Med , vol.22 , Issue.2 , pp. 169-186
    • D’Agostino, R.B.1
  • 81
    • 77957833984 scopus 로고    scopus 로고
    • Cancer biomarkers: Can we turn recent failures into success?
    • Diamardis EP. 2010. Cancer biomarkers: Can we turn recent failures into success? JNCI 102(19): 1462-1467.
    • (2010) JNCI , vol.102 , Issue.19 , pp. 1462-1467
    • Diamardis, E.P.1
  • 82
    • 19944433460 scopus 로고    scopus 로고
    • A responsive outcome for Parkinson’s disease neuroprotection futility studies
    • Elm JJ et al. 2005. A responsive outcome for Parkinson’s disease neuroprotection futility studies. Ann Neurol 57(2): 197-203.
    • (2005) Ann Neurol , vol.57 , Issue.2 , pp. 197-203
    • Elm, J.J.1
  • 83
    • 34249805427 scopus 로고    scopus 로고
    • When and how can endpoints be changed after initiation of a randomized clinical trial?
    • Evans SR. 2007. When and how can endpoints be changed after initiation of a randomized clinical trial?. Public Library of Science (PLoS) Clin Trials 2(4): e18. doi: 10.1371/journal.pctr.0020018.
    • (2007) Public Library of Science (PLoS) Clin Trials , vol.2 , Issue.4 , pp. e18
    • Evans, S.R.1
  • 84
    • 0036682006 scopus 로고    scopus 로고
    • A phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressed AIDS-related Kaposi’s Sarcoma: An ACTG clinical study
    • Evans SR, Testa MA, Cooley TP, Krown SE, Paredes J, Von Roenn JH. 2002. A phase II evaluation of low-dose oral etoposide for the treatment of relapsed or progressed AIDS-related Kaposi’s Sarcoma: An ACTG clinical study. J Clin Oncol 20(15): 3236-3241.
    • (2002) J Clin Oncol , vol.20 , Issue.15 , pp. 3236-3241
    • Evans, S.R.1    Testa, M.A.2    Cooley, T.P.3    Krown, S.E.4    Paredes, J.5    Von Roenn, J.H.6
  • 85
    • 79954697705 scopus 로고    scopus 로고
    • Peripheral neuropathy in HIV: Prevalence and risk factors
    • Evans SR et al. 2011. Peripheral neuropathy in HIV: Prevalence and risk factors. AIDS 25: 919-928.
    • (2011) AIDS , vol.25 , pp. 919-928
    • Evans, S.R.1
  • 86
    • 0141664744 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). January 2001
    • FDA Guidance. 2002. Statistical approaches to establishing bioequivalence. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). January 2001.
    • (2002) Statistical approaches to establishing bioequivalence
  • 87
    • 84860741807 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Center for Devices and Radiological Health (CDRH). December 2012
    • FDA Guidance. 2012. Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products. U.S. Department of Health and Human Services. Food and Drug Administration. Center for Drug Evaluation and Research (CDER). Center for Biologics Evaluation and Research (CBER). Center for Devices and Radiological Health (CDRH). December 2012.
    • (2012) Guidance for industry: Enrichment strategies for clinical trials to support approval of human drugs and biological products
  • 88
    • 76349100026 scopus 로고    scopus 로고
    • Randomized clinical trials with biomarkers: Design issues
    • Freidlin B, McShane LM, Korn EL. 2010. Randomized clinical trials with biomarkers: design issues. J Natl Cancer Inst 102: 152-160.
    • (2010) J Natl Cancer Inst , vol.102 , pp. 152-160
    • Freidlin, B.1    McShane, L.M.2    Korn, E.L.3
  • 89
    • 38949135933 scopus 로고    scopus 로고
    • Assessing non-inferiority: A combination approach
    • Gau P and Ware JH. 2007. Assessing non-inferiority: A combination approach. Stat. Med. 27(3): 392-406.
    • (2007) Stat. Med , vol.27 , Issue.3 , pp. 392-406
    • Gau, P.1    Ware, J.H.2
  • 92
    • 36248948108 scopus 로고    scopus 로고
    • Discussion of the “White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs”
    • Grieve A. 2007. Discussion of the “White Paper of the PhRMA Working Group on Adaptive Dose-Ranging Designs”. J Biopharm Stat 17(6): 997-1004.
    • (2007) J Biopharm Stat , vol.17 , Issue.6 , pp. 997-1004
    • Grieve, A.1
  • 93
    • 50949126827 scopus 로고    scopus 로고
    • A Weighted risk set estimator for survival distributions in two-stage randomization designs with censored survival data
    • Guo X, Tsiatis AA. 2005. A Weighted risk set estimator for survival distributions in two-stage randomization designs with censored survival data. Int J Biostat, Berkeley Electronic Press 1(1): 1-15.
    • (2005) Int J Biostat, Berkeley Electronic Press , vol.1 , Issue.1 , pp. 1-15
    • Guo, X.1    Tsiatis, A.A.2
  • 94
    • 0036978467 scopus 로고    scopus 로고
    • Dose spacing in early dose response clinical trial designs
    • Hamlett A, Ting N, Hanumara C, Finman JS. 2002. Dose spacing in early dose response clinical trial designs. Drug Inf J 36(4): 855-864.
    • (2002) Drug Inf J , vol.36 , Issue.4 , pp. 855-864
    • Hamlett, A.1    Ting, N.2    Hanumara, C.3    Finman, J.S.4
  • 95
    • 0035584856 scopus 로고    scopus 로고
    • Journals should see original protocols for clinical trials
    • Hawkey CJ. 2001. Journals should see original protocols for clinical trials. BMJ 323: 1309.
    • (2001) BMJ , vol.323 , pp. 1309
    • Hawkey, C.J.1
  • 96
    • 33745842238 scopus 로고    scopus 로고
    • Estimating causal effects from epidemiological data
    • Hernan MA, Robins JM. 2006. Estimating causal effects from epidemiological data. J Epidemiol Community Health 60(7): 578-86.
    • (2006) J Epidemiol Community Health , vol.60 , Issue.7 , pp. 578-586
    • Hernan, M.A.1    Robins, J.M.2
  • 97
    • 0030548462 scopus 로고    scopus 로고
    • Nonparametric and semiparametric estimation of the receiver operating characteristic curve
    • Hsieh F, Turnbull B. 1996. Nonparametric and semiparametric estimation of the receiver operating characteristic curve. Ann Stat 24(1): 25-40.
    • (1996) Ann Stat , vol.24 , Issue.1 , pp. 25-40
    • Hsieh, F.1    Turnbull, B.2
  • 99
    • 0036968867 scopus 로고    scopus 로고
    • Seamlessly expanding a randomized phase II trial to phase III
    • Inoue LYT, Thall PF, Berry DA. 2002. Seamlessly expanding a randomized phase II trial to phase III. Biometrics 58: 823-831.
    • (2002) Biometrics , vol.58 , pp. 823-831
    • Inoue, L.Y.T.1    Thall, P.F.2    Berry, D.A.3
  • 100
    • 2442678626 scopus 로고    scopus 로고
    • E-9. Available, Accessed March 6, 2007
    • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH E9). 1998. ICH harmonized tripartite guideline: Statistical principles for clinical trials, E-9. Available: http://www.ich.org/LOB/media/MEDIA485.pdf. Accessed March 6, 2007.
    • (1998) ICH harmonized tripartite guideline: Statistical principles for clinical trials
  • 101
    • 79957789708 scopus 로고    scopus 로고
    • Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses
    • Ioannidis JPA and Panagioutou OA. 2011. Comparison of effect sizes associated with biomarkers reported in highly cited individual articles and in subsequent meta-analyses. JAMA 305(21): 2200-2210.
    • (2011) JAMA , vol.305 , Issue.21 , pp. 2200-2210
    • Ioannidis, J.P.A.1    Panagioutou, O.A.2
  • 103
    • 70249116820 scopus 로고    scopus 로고
    • Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III
    • Kaufmann P et al. 2009. Phase II trial of CoQ10 for ALS finds insufficient evidence to justify phase III. Ann Neurol 66: 235-244.
    • (2009) Ann Neurol , vol.66 , pp. 235-244
    • Kaufmann, P.1
  • 104
    • 85123143274 scopus 로고    scopus 로고
    • ASTIN: An adaptive dose-response study of UK-279, 276 in acute ischemic stroke
    • Krams M, Lees KR, Hacke W, Grieve AP, Orgogozo JM, Ford GA, and for the ASTIN Study Investigators. 2003. ASTIN: An adaptive dose-response study of UK-279, 276 in acute ischemic stroke. Stroke 34: 2543-254.
    • (2003) Stroke , vol.34 , pp. 2254-2543
    • Krams, M.1    Lees, K.R.2    Hacke, W.3    Grieve, A.P.4    Orgogozo, J.M.5    Ford, G.A.6
  • 105
    • 34547670275 scopus 로고    scopus 로고
    • Cox regression methods for two-stage randomization designs
    • Lokhnygina Y, Helterbrand JD. 2007. Cox regression methods for two-stage randomization designs. Biometrics 63(2): 422-428.
    • (2007) Biometrics , vol.63 , Issue.2 , pp. 422-428
    • Lokhnygina, Y.1    Helterbrand, J.D.2
  • 106
    • 0036192067 scopus 로고    scopus 로고
    • Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials
    • Lunceford JK, Davidian M, Tsiatis AA. 2002. Estimation of survival distributions of treatment policies in two-stage randomization designs in clinical trials. Biometrics 58: 48-57.
    • (2002) Biometrics , vol.58 , pp. 48-57
    • Lunceford, J.K.1    Davidian, M.2    Tsiatis, A.A.3
  • 107
    • 33750854113 scopus 로고    scopus 로고
    • Adaptive seamless phase II/III designs: Background, operational aspects, and examples
    • Maca J, Bhattacharya S, Dragalin V, Gallo P, Krams M. 2006. Adaptive seamless phase II/III designs: background, operational aspects, and examples. Drug Inf J 40(4): 463-473.
    • (2006) Drug Inf J , vol.40 , Issue.4 , pp. 463-473
    • Maca, J.1    Bhattacharya, S.2    Dragalin, V.3    Gallo, P.4    Krams, M.5
  • 108
    • 38949196447 scopus 로고    scopus 로고
    • HLA-B*5701 screening for hypersensitivity to abacavir
    • Mallal S. et al. 2008. HLA-B*5701 screening for hypersensitivity to abacavir. NEJM 358: 568-579.
    • (2008) NEJM , vol.358 , pp. 568-579
    • Mallal, S.1
  • 109
    • 0038312289 scopus 로고    scopus 로고
    • Analysis and reporting of factorial trials: A systematic review
    • McAlister FA, Straus SE, Sackett DL, Altman DG. 2003. Analysis and reporting of factorial trials: A systematic review. JAMA 289: 2545-2553.
    • (2003) JAMA , vol.289 , pp. 2545-2553
    • McAlister, F.A.1    Straus, S.E.2    Sackett, D.L.3    Altman, D.G.4
  • 110
    • 3042728223 scopus 로고    scopus 로고
    • Design, analysis, and presentation of factorial randomized controlled trials
    • Montgomery AA, Peters TJ, Little P. 2003. Design, analysis, and presentation of factorial randomized controlled trials. BMC Med Res Methodol 3: 26.
    • (2003) BMC Med Res Methodol , vol.3 , pp. 26
    • Montgomery, A.A.1    Peters, T.J.2    Little, P.3
  • 111
    • 0038107066 scopus 로고    scopus 로고
    • Optimal dynamic treatment regimes (with discussion)
    • Murphy SA. 2003. Optimal dynamic treatment regimes (with discussion). JRSS-B 65: 331-366.
    • (2003) JRSS-B , vol.65 , pp. 331-366
    • Murphy, S.A.1
  • 112
    • 1542469617 scopus 로고    scopus 로고
    • Marginal mean models for dynamic regimes
    • Murphy SA, vander Laan MJ, Robins JM. 2001. Marginal mean models for dynamic regimes. JASA 96: 1410-1423.
    • (2001) JASA , vol.96 , pp. 1410-1423
    • Murphy, S.A.1    Vander Laan, M.J.2    Robins, J.M.3
  • 113
    • 27644481285 scopus 로고    scopus 로고
    • Applying a phase II futility study design to therapeutic stroke trials
    • Palesch Y, Tilley BC, Sackett DL, Johnston KC, Woolson R. 2005. Applying a phase II futility study design to therapeutic stroke trials. Stroke 36: 2410-2414.
    • (2005) Stroke , vol.36 , pp. 2410-2414
    • Palesch, Y.1    Tilley, B.C.2    Sackett, D.L.3    Johnston, K.C.4    Woolson, R.5
  • 114
    • 0033458198 scopus 로고    scopus 로고
    • Adaptive two-satge designs and the conditional error function
    • Posch M, Bauer P. Adaptive two-satge designs and the conditional error function. Biometrical J 1999, 41: 689-696.
    • (1999) Biometrical J , vol.41 , pp. 689-696
    • Posch, M.1    Bauer, P.2
  • 115
    • 30944469129 scopus 로고    scopus 로고
    • Testing and estimation in flexible group sequential designs with adaptive treatment selection
    • Posch M, Koenig F, Branson M, Brannath W, Dunger-Baldauf C, Bauer P. 2005. Testing and estimation in flexible group sequential designs with adaptive treatment selection. Stat Med 24: 3697-3714.
    • (2005) Stat Med , vol.24 , pp. 3697-3714
    • Posch, M.1    Koenig, F.2    Branson, M.3    Brannath, W.4    Dunger-Baldauf, C.5    Bauer, P.6
  • 116
    • 0027524863 scopus 로고
    • Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents
    • Ratain MJ, Mick R, Schilsky RL, Siegler M. 1993. Statistical and ethical issues in the design and conduct of phase I and II clinical trials of new anticancer agents. J Natl Cancer Inst 85: 1637-1643.
    • (1993) J Natl Cancer Inst , vol.85 , pp. 1637-1643
    • Ratain, M.J.1    Mick, R.2    Schilsky, R.L.3    Siegler, M.4
  • 117
    • 10744220820 scopus 로고    scopus 로고
    • Sequenced treatment alternatives to relieve depression (STAR*D): Rationale and design
    • Rush AJ et al. 2004. Sequenced treatment alternatives to relieve depression (STAR*D): Rationale and design. Controlled Clin Trials 25(1): 119-142.
    • (2004) Controlled Clin Trials , vol.25 , Issue.1 , pp. 119-142
    • Rush, A.J.1
  • 118
    • 35948994165 scopus 로고    scopus 로고
    • Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint
    • Schmidli H, Bretz F, Racine-Poon A. 2007. Bayesian predictive power for interim adaptation in seamless phase II/III trials where the endpoint is survival up to some specified timepoint. Stat Med 26: 4925-4938.
    • (2007) Stat Med , vol.26 , pp. 4925-4938
    • Schmidli, H.1    Bretz, F.2    Racine-Poon, A.3
  • 119
    • 0034752199 scopus 로고    scopus 로고
    • National Institute of Mental Health clinical antipsychotic trials of intervention effectiveness (CATIE): Alzheimer disease trial methodology
    • Schneider LS et al. 2007. National Institute of Mental Health clinical antipsychotic trials of intervention effectiveness (CATIE): Alzheimer disease trial methodology. Am J Geriatr Psychiatry 9(4): 346-60.
    • (2007) Am J Geriatr Psychiatry , vol.9 , Issue.4 , pp. 346-360
    • Schneider, L.S.1
  • 120
    • 0024536437 scopus 로고
    • Optimal two stage design of phase II clinical trials
    • Simon R. 1989. Optimal two stage design of phase II clinical trials. Control Clin Trials 10: 1-10.
    • (1989) Control Clin Trials , vol.10 , pp. 1-10
    • Simon, R.1
  • 121
    • 84867439073 scopus 로고    scopus 로고
    • Clinical trials for predictive medicine
    • Simon R. 2012. Clinical trials for predictive medicine. Stat Med 31(25): 3031-3040.
    • (2012) Stat Med , vol.31 , Issue.25 , pp. 3031-3040
    • Simon, R.1
  • 122
    • 0032508983 scopus 로고    scopus 로고
    • Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: A randomized controlled trial
    • Shlay JC et al. 1998. Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: A randomized controlled trial. JAMA 280(18): 1590-1595.
    • (1998) JAMA , vol.280 , Issue.18 , pp. 1590-1595
    • Shlay, J.C.1
  • 124
    • 35648935906 scopus 로고    scopus 로고
    • Bayesian and frequentist two-stage treatment strategies based on sequential failure times subject to interval censoring
    • Thall PF, Wooten LH, Logothetis CJ, Millikan R, Tannir NM. 2007. Bayesian and frequentist two-stage treatment strategies based on sequential failure times subject to interval censoring. Stat Med 26: 4687-4702.
    • (2007) Stat Med , vol.26 , pp. 4687-4702
    • Thall, P.F.1    Wooten, L.H.2    Logothetis, C.J.3    Millikan, R.4    Tannir, N.M.5
  • 125
    • 33645864949 scopus 로고    scopus 로고
    • Optimizing the ongoing search for new treatments for Parkinson disease: Using futility designs
    • Tilley BC et al. 2006. Optimizing the ongoing search for new treatments for Parkinson disease: Using futility designs. Neurology 66: 628-633.
    • (2006) Neurology , vol.66 , pp. 628-633
    • Tilley, B.C.1
  • 126
    • 57449091501 scopus 로고    scopus 로고
    • Confirm and explore, a stepwise approach to clinical trial designs
    • Ting, N. 2008. Confirm and explore, a stepwise approach to clinical trial designs. Drug Information Journal 42(6): 545-554.
    • (2008) Drug Information Journal , vol.42 , Issue.6 , pp. 545-554
    • Ting, N.1
  • 127
    • 78649369122 scopus 로고    scopus 로고
    • A Futility Study of Minocycline in Huntington’s Disease
    • The Huntington Study Group DOMINO Investigators. 2010. A Futility Study of Minocycline in Huntington’s Disease. Mov Disord 25(13): 2219-2224.
    • (2010) Mov Disord , vol.25 , Issue.13 , pp. 2219-2224
  • 128
    • 33645894705 scopus 로고    scopus 로고
    • A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease
    • The NINDS NET-PD Investigators. 2006. A randomized, double-blind, futility clinical trial of creatine and minocycline in early Parkinson disease. Neurology 66: 664-671.
    • (2006) Neurology , vol.66 , pp. 664-671
  • 129
    • 33846115045 scopus 로고    scopus 로고
    • A clinical trial of coenzyme Q10 and GPI-1485 in in early Parkinson disease
    • The NINDS NET-PD Investigators. 2007. A clinical trial of coenzyme Q10 and GPI-1485 in in early Parkinson disease. Neurology 68: 20-28.
    • (2007) Neurology , vol.68 , pp. 20-28
  • 130
    • 1642358199 scopus 로고    scopus 로고
    • Optimal estimator for the survival distribution and related quantities for treatment policies in two-stage randomization designs in clinical trials
    • Wahed AS, Tsiatis AA. 2004. Optimal estimator for the survival distribution and related quantities for treatment policies in two-stage randomization designs in clinical trials. Biometrics 60: 124-133.
    • (2004) Biometrics , vol.60 , pp. 124-133
    • Wahed, A.S.1    Tsiatis, A.A.2
  • 131
    • 33644973742 scopus 로고    scopus 로고
    • Semiparametric efficient estimation of survival distribution for treatment policies in two-stage randomization designs in clinical trials with censored data
    • Wahed AS, Tsiatis AA. 2006. Semiparametric efficient estimation of survival distribution for treatment policies in two-stage randomization designs in clinical trials with censored data. Biometrika 93: 163-177.
    • (2006) Biometrika , vol.93 , pp. 163-177
    • Wahed, A.S.1    Tsiatis, A.A.2
  • 132
    • 0037108040 scopus 로고    scopus 로고
    • On changing a long-term trial midstream
    • Wittes J. 2002. On changing a long-term trial midstream. Stat Med 27: 2789-2795.
    • (2002) Stat Med , vol.27 , pp. 2789-2795
    • Wittes, J.1
  • 133
    • 0030604427 scopus 로고    scopus 로고
    • Tutorial in biostatistics: Designing studies for dose response
    • Wong WK, Lachenbruch PA. 1996, Tutorial in biostatistics: Designing studies for dose response. Stat Med 15: 343-359.
    • (1996) Stat Med , vol.15 , pp. 343-359
    • Wong, W.K.1    Lachenbruch, P.A.2
  • 134
    • 0023927449 scopus 로고
    • The preliminary report of the findings of the aspirin component of the ongoing Physicians’ Health Study. The FDA perspective on aspirin for the primary prevention of myocardial infarction
    • Young F, Nightingale S, Temple R. 1988. The preliminary report of the findings of the aspirin component of the ongoing Physicians’ Health Study. The FDA perspective on aspirin for the primary prevention of myocardial infarction. JAMA 259: 3158-3160.
    • (1988) JAMA , vol.259 , pp. 3158-3160
    • Young, F.1    Nightingale, S.2    Temple, R.3
  • 135
    • 33645852575 scopus 로고    scopus 로고
    • A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS
    • Zhou X et al. 2006. A two-stage design for a phase II clinical trial of coenzyme Q10 in ALS. Neurology 66: 660-663.
    • (2006) Neurology , vol.66 , pp. 660-663
    • Zhou, X.1
  • 136
    • 0022395309 scopus 로고
    • Early decision in clinical trials when treatment differences are small
    • Choi SC, Smith PJ, Becker DP. 1985. Early decision in clinical trials when treatment differences are small. Controlled Clin Trials 6: 280-288.
    • (1985) Controlled Clin Trials , vol.6 , pp. 280-288
    • Choi, S.C.1    Smith, P.J.2    Becker, D.P.3
  • 140
    • 36249028240 scopus 로고    scopus 로고
    • Data monitoring in clinical trials using prediction
    • Evans SR, Li L, Wei LJ. 2007a. Data monitoring in clinical trials using prediction. Drug Inf J 41: 733-742.
    • (2007) Drug Inf J , vol.41 , pp. 733-742
    • Evans, S.R.1    Li, L.2    Wei, L.J.3
  • 141
    • 84903836051 scopus 로고    scopus 로고
    • A randomized trial evaluating prosaptide™ for HIV-associated sensory neuropathies: Use of an electronic diary to record neuropathic pain
    • Evans SR, Simpson D, Kitch DW, King A, Clifford DB, Cohen BA, McArthur JC. 2007b. A randomized trial evaluating prosaptide™ for HIV-associated sensory neuropathies: use of an electronic diary to record neuropathic pain. PLoS One 2(7): e551. doi: 10.1371/journal.pone.0000551.
    • (2007) PLoS One , vol.2 , Issue.7 , pp. e551
    • Evans, S.R.1    Simpson, D.2    Kitch, D.W.3    King, A.4    Clifford, D.B.5    Cohen, B.A.6    McArthur, J.C.7
  • 142
    • 0008984727 scopus 로고
    • Group sequential methods for clinical trials allowing early acceptance of H0 and incorporating costs
    • Gould AL, Pecore VJ. 1982. Group sequential methods for clinical trials allowing early acceptance of H0 and incorporating costs. Biometrika 69(1): 75-80.
    • (1982) Biometrika , vol.69 , Issue.1 , pp. 75-80
    • Gould, A.L.1    Pecore, V.J.2
  • 143
    • 78650549662 scopus 로고    scopus 로고
    • Preexposure chemoprophylaxis for HIV prevention in men who have sex with men
    • Grant RM et al. 2010. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med 363: 2587-2599.
    • (2010) N Engl J Med , vol.363 , pp. 2587-2599
    • Grant, R.M.1
  • 144
    • 0000860006 scopus 로고
    • Procedures for serial testing in censored survival data
    • Crowley J, Johnson RA (Eds.), Hayward, CA: Institute of Mathematical Statistics
    • Harrington DP, Fleming TR, Green SJ. 1982. Procedures for serial testing in censored survival data. In: Crowley J, Johnson RA (Eds.), Survival Analysis.. Hayward, CA: Institute of Mathematical Statistics. pp. 269-286.
    • (1982) Survival Analysis. , pp. 269-286
    • Harrington, D.P.1    Fleming, T.R.2    Green, S.J.3
  • 146
    • 0021323563 scopus 로고
    • Repeated confidence intervals for group sequential clinical trials
    • Jennison C, Turnbull BW. 1984. Repeated confidence intervals for group sequential clinical trials. Controlled Clin Trials 5: 33-45.
    • (1984) Controlled Clin Trials , vol.5 , pp. 33-45
    • Jennison, C.1    Turnbull, B.W.2
  • 147
    • 0000785248 scopus 로고
    • Design and analysis of group sequential tests based on the type I error spending rate function
    • Kim KKG, DeMets DL. 1987. Design and analysis of group sequential tests based on the type I error spending rate function. Biometrika 74: 149-154.
    • (1987) Biometrika , vol.74 , pp. 149-154
    • Kim, K.K.G.1    DeMets, D.L.2
  • 148
    • 70449529019 scopus 로고
    • Discrete sequential boundaries for clinical trials
    • Lan KKG, DeMets DL. 1983. Discrete sequential boundaries for clinical trials. Biometrika 70(3): 659-663.
    • (1983) Biometrika , vol.70 , Issue.3 , pp. 659-663
    • Lan, K.K.G.1    DeMets, D.L.2
  • 149
    • 84953030627 scopus 로고
    • Stochastically curtained tests in long-term clinical trials
    • Lan KKG, Simon R, Halperin M. 1982. Stochastically curtained tests in long-term clinical trials. Commun Stat C 1: 207-219.
    • (1982) Commun Stat C , vol.1 , pp. 207-219
    • Lan, K.K.G.1    Simon, R.2    Halperin, M.3
  • 150
    • 84901806870 scopus 로고    scopus 로고
    • Predicted interval plots: A graphical tool for data monitoring in clinical trials
    • Li L, Evans SR, Uno H, Wei LJ. 2009. Predicted interval plots: a graphical tool for data monitoring in clinical trials. Stat Biopharm Res 1(4): 348-355.
    • (2009) Stat Biopharm Res , vol.1 , Issue.4 , pp. 348-355
    • Li, L.1    Evans, S.R.2    Uno, H.3    Wei, L.J.4
  • 151
    • 0018687930 scopus 로고
    • A multiple testing procedure for clinical trials
    • O’Brien PC, Fleming TR. 1979. A multiple testing procedure for clinical trials. Biometrics 35: 549-556.
    • (1979) Biometrics , vol.35 , pp. 549-556
    • O’Brien, P.C.1    Fleming, T.R.2
  • 152
    • 0002296743 scopus 로고
    • Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis
    • Pampallona S, Tsiatis AA. 1994. Group sequential designs for one-sided and two-sided hypothesis testing with provision for early stopping in favor of the null hypothesis. J Stat Plann Inferace 42: 19-35.
    • (1994) J Stat Plann Inferace , vol.42 , pp. 19-35
    • Pampallona, S.1    Tsiatis, A.A.2
  • 153
    • 0035739456 scopus 로고    scopus 로고
    • Interim monitoring of group sequential trials using spending functions for the type I and type II error probabilities
    • Pampallona S, Tsiatis AA, Kim K. 2001. Interim monitoring of group sequential trials using spending functions for the type I and type II error probabilities. Drug Inf J 35: 1113-1121.
    • (2001) Drug Inf J , vol.35 , pp. 1113-1121
    • Pampallona, S.1    Tsiatis, A.A.2    Kim, K.3
  • 154
    • 0017744944 scopus 로고
    • Group sequential methods in the design and analysis of clinical trials
    • Pocock SJ. 1977. Group sequential methods in the design and analysis of clinical trials. Biometrika 64: 191-199.
    • (1977) Biometrika , vol.64 , pp. 191-199
    • Pocock, S.J.1
  • 155
    • 0001538421 scopus 로고
    • Two-sample repeated significance tests based on the modified Wilcoxon statistic
    • Slud EV, Wei LJ. 1982. Two-sample repeated significance tests based on the modified Wilcoxon statistic. J Am Stat Assoc 77: 862-868.
    • (1982) J Am Stat Assoc , vol.77 , pp. 862-868
    • Slud, E.V.1    Wei, L.J.2
  • 156
    • 0039051561 scopus 로고
    • Group sequential methods for survival analysis with staggered entry
    • Crowley J, Johnson RA (Eds.), Hayward, CA: Institute of Mathematical Statistics
    • Tsiatis AA. 1982. Group sequential methods for survival analysis with staggered entry. In: Crowley J, Johnson RA (Eds.), Survival Analysis. Hayward, CA: Institute of Mathematical Statistics. pp. 257-268.
    • (1982) Survival Analysis. , pp. 257-268
    • Tsiatis, A.A.1
  • 157
    • 84893786376 scopus 로고    scopus 로고
    • U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Office of Good Clinical Practice (OGCP) Office of Regulatory Affairs (ORA) August 2013 Procedural
    • US FDA. 2013. Guidance for industry oversight of clinical investigations-A risk-based approach to monitoring. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Center for Devices and Radiological Health (CDRH) Office of Good Clinical Practice (OGCP) Office of Regulatory Affairs (ORA) August 2013 Procedural.
    • (2013) Guidance for industry oversight of clinical investigations-A risk-based approach to monitoring
  • 158
    • 0023217456 scopus 로고
    • Approximately optimal one-parameter boundaries for group sequential trials
    • Wang SK, Tsiatis AA. 1987. Approximately optimal one-parameter boundaries for group sequential trials. Biometrics 43: 193-199.
    • (1987) Biometrics , vol.43 , pp. 193-199
    • Wang, S.K.1    Tsiatis, A.A.2
  • 159
    • 0021951614 scopus 로고
    • The futility index: An approach to the cost-effective termination of randomized clinical trials
    • Ware JH, Muller JE, Braunwald E. 1985. The futility index: An approach to the cost-effective termination of randomized clinical trials. Am J Med 78: 635-643.
    • (1985) Am J Med , vol.78 , pp. 635-643
    • Ware, J.H.1    Muller, J.E.2    Braunwald, E.3
  • 161
    • 0020729398 scopus 로고
    • Group sequential clinical trials with triangular continuation regions
    • Whitehead J, Stratton U. 1983. Group sequential clinical trials with triangular continuation regions. Biometrics 39: 227-236.
    • (1983) Biometrics , vol.39 , pp. 227-236
    • Whitehead, J.1    Stratton, U.2
  • 163
    • 84971580244 scopus 로고
    • Absence of evidence is not evidence of absence
    • Altman DG, Bland JM. 1995. Absence of evidence is not evidence of absence. BMJ 311: 485.
    • (1995) BMJ , vol.311 , pp. 485
    • Altman, D.G.1    Bland, J.M.2
  • 164
    • 0000862163 scopus 로고    scopus 로고
    • Improving doctors’ understanding of statistics
    • Altman DG, Bland JM. 1998. Improving doctors’ understanding of statistics. J R Stat Soc A 154: 223-267.
    • (1998) J R Stat Soc A , vol.154 , pp. 223-267
    • Altman, D.G.1    Bland, J.M.2
  • 165
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baseline data in clinical trials
    • Assman SF et al. 2000. Subgroup analysis and other (mis)uses of baseline data in clinical trials. Lancet 355: 1064-1069.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assman, S.F.1
  • 166
    • 0022501491 scopus 로고
    • The influence of interpretability on the assessment of diagnostic tests
    • Begg CB, Geenes RA, Iglewics B. 1986. The influence of interpretability on the assessment of diagnostic tests. J Chronic Dis 39(8): 575-584.
    • (1986) J Chronic Dis , vol.39 , Issue.8 , pp. 575-584
    • Begg, C.B.1    Geenes, R.A.2    Iglewics, B.3
  • 167
    • 0034653364 scopus 로고    scopus 로고
    • Comparing diagnostic tests: A simple graphic using likelihood ratios
    • Biggerstaff BJ. 2000. Comparing diagnostic tests: A simple graphic using likelihood ratios. Stat Med 19: 649-663.
    • (2000) Stat Med , vol.19 , pp. 649-663
    • Biggerstaff, B.J.1
  • 168
    • 0034668136 scopus 로고    scopus 로고
    • A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data
    • Bonetti M, Gelber RD. 2000. A graphical method to assess treatment-covariate interactions using the Cox model on subsets of the data. Stat Med 19: 2595-2609.
    • (2000) Stat Med , vol.19 , pp. 2595-2609
    • Bonetti, M.1    Gelber, R.D.2
  • 169
    • 20044377408 scopus 로고    scopus 로고
    • Patterns of treatment effects in subsets of patients in clinical trials
    • Bonetti M, Gelber RD. 2004. Patterns of treatment effects in subsets of patients in clinical trials. Biostatistics 5(3): 465-81.
    • (2004) Biostatistics , vol.5 , Issue.3 , pp. 465-481
    • Bonetti, M.1    Gelber, R.D.2
  • 170
    • 79953133534 scopus 로고    scopus 로고
    • Analysis of randomized comparative clinical trial data for personalized treatment selections
    • Cai T et al. 2011. Analysis of randomized comparative clinical trial data for personalized treatment selections. Biostatistics 12(2): 270-282.
    • (2011) Biostatistics , vol.12 , Issue.2 , pp. 270-282
    • Cai, T.1
  • 172
    • 31144457525 scopus 로고    scopus 로고
    • Clinical validation of the NeuroScreen
    • Ellis RJ et al. 2005. Clinical validation of the NeuroScreen. J NeuroVirol 11: 503-511.
    • (2005) J NeuroVirol , vol.11 , pp. 503-511
    • Ellis, R.J.1
  • 173
    • 85123158859 scopus 로고    scopus 로고
    • A presentation at the annual meeting of the AIDS Clinical Trials Group
    • Evans SR. 2012. SOS Plots. A presentation at the annual meeting of the AIDS Clinical Trials Group.
    • (2012) SOS Plots
    • Evans, S.R.1
  • 174
    • 0037151796 scopus 로고    scopus 로고
    • Post-randomization exclusions: The intention to treat principle and excluding patients from analysis
    • Fergusson D, Aaron SD, Guyatt G, Hebert P. 2002. Post-randomization exclusions: The intention to treat principle and excluding patients from analysis. BMJ 325: 652-654.
    • (2002) BMJ , vol.325 , pp. 652-654
    • Fergusson, D.1    Aaron, S.D.2    Guyatt, G.3    Hebert, P.4
  • 175
    • 0023049334 scopus 로고
    • Confidence intervals rather than p-values: Estimation rather than hypothesis testing
    • Gardner MJ, Altman DG. 1986. Confidence intervals rather than p-values: Estimation rather than hypothesis testing. BMJ 292: 746-750.
    • (1986) BMJ , vol.292 , pp. 746-750
    • Gardner, M.J.1    Altman, D.G.2
  • 176
    • 35348821297 scopus 로고    scopus 로고
    • The intention-to-treat approach in randomized controlled trials: Are authors saying what they do and doing what they say?
    • Gravel J, Opatrny L, Shapiro S. 2007. The intention-to-treat approach in randomized controlled trials: Are authors saying what they do and doing what they say? Clin Trials 4(4): 350-356.
    • (2007) Clin Trials , vol.4 , Issue.4 , pp. 350-356
    • Gravel, J.1    Opatrny, L.2    Shapiro, S.3
  • 177
    • 33645484954 scopus 로고    scopus 로고
    • Kappa statistic is not satisfactory for assessing the extent of agreement between raters
    • April 2002
    • Gwet K. 2002. Kappa statistic is not satisfactory for assessing the extent of agreement between raters. Statist Methods Inter-Rater Reliability Assessment, No. 1, April 2002, pp. 1-5.
    • (2002) Statist Methods Inter-Rater Reliability Assessment , vol.1 , pp. 1-5
    • Gwet, K.1
  • 178
    • 0033546995 scopus 로고    scopus 로고
    • What is meant by intention to treat analysis? Survey of published randomised controlled trials
    • Hollis S and Campbell F. 1999. What is meant by intention to treat analysis? Survey of published randomised controlled trials. BMJ 319: 670-674.
    • (1999) BMJ , vol.319 , pp. 670-674
    • Hollis, S.1    Campbell, F.2
  • 179
    • 0037125429 scopus 로고    scopus 로고
    • Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node-negative breast cancer: A randomized trial
    • International Breast Cancer Study Group (IBCG) (Castiglione et al.). 2002. Endocrine responsiveness and tailoring adjuvant therapy for postmenopausal lymph node-negative breast cancer: A randomized trial. J Natl Cancer Inst 94: 1054-1065.
    • (2002) J Natl Cancer Inst , vol.94 , pp. 1054-1065
  • 181
    • 0034061095 scopus 로고    scopus 로고
    • Statistical considerations in the intent-to-treat principle
    • Lachin JM. 2000. Statistical considerations in the intent-to-treat principle. Controlled Clinical Trials 21: 167-189.
    • (2000) Controlled Clinical Trials , vol.21 , pp. 167-189
    • Lachin, J.M.1
  • 182
    • 79959341794 scopus 로고    scopus 로고
    • Estimating subject-specific dependent competing risk profile with censored event time observations
    • Li Y et al. 2011. Estimating subject-specific dependent competing risk profile with censored event time observations. Biometrics 67(2): 427-435.
    • (2011) Biometrics , vol.67 , Issue.2 , pp. 427-435
    • Li, Y.1
  • 183
    • 84867183673 scopus 로고    scopus 로고
    • The prevention and treatment of missing data
    • Little RJ et al. 2012. The prevention and treatment of missing data. NEJM 367(14): 1355-1360.
    • (2012) NEJM , vol.367 , Issue.14 , pp. 1355-1360
    • Little, R.J.1
  • 186
  • 189
    • 70349240321 scopus 로고    scopus 로고
    • The effects of excluding patients from the analysis in randomized controlled trials: Meta-epidemiological study
    • Nuesch E, Trelle S, Reichenbach S, Rutjes AWS, Burgi E, Scherer M, Altman DG, Juni P. 2009. The effects of excluding patients from the analysis in randomized controlled trials: Meta-epidemiological study. BMJ 339: b3244 doi: 10.1136/bmj.b3244.
    • (2009) BMJ , vol.339 , pp. b3244
    • Nuesch, E.1    Trelle, S.2    Reichenbach, S.3    Rutjes, A.W.S.4    Burgi, E.5    Scherer, M.6    Altman, D.G.7    Juni, P.8
  • 190
    • 34248397713 scopus 로고    scopus 로고
    • Tutorial in biostatistics: Competing risks and multi-state models
    • Putter H, Fiocco M, Geskus RB. 2007. Tutorial in biostatistics: Competing risks and multi-state models. Stat Med 26: 2389-2430.
    • (2007) Stat Med , vol.26 , pp. 2389-2430
    • Putter, H.1    Fiocco, M.2    Geskus, R.B.3
  • 192
    • 84865482221 scopus 로고    scopus 로고
    • Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study
    • Robertson K et al. 2012. Improved neuropsychological and neurological functioning across three antiretroviral regimens in diverse resource-limited settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study. CID 55(6): 868-876.
    • (2012) CID , vol.55 , Issue.6 , pp. 868-876
    • Robertson, K.1
  • 193
    • 21844487694 scopus 로고
    • Semiparametric e_ciency in multivariate regression models with missing data
    • Robins JM, Rotnitzky A. 1995. Semiparametric e_ciency in multivariate regression models with missing data. J Am Stat Assoc 90: 122-129.
    • (1995) J Am Stat Assoc , vol.90 , pp. 122-129
    • Robins, J.M.1    Rotnitzky, A.2
  • 194
    • 84950421496 scopus 로고
    • Analysis of semiparametric regression models for repeated outcomes in the presence of missing data
    • Robins JM, Rotnitzky A, Zhao LP. 1995. Analysis of semiparametric regression models for repeated outcomes in the presence of missing data. J Am Stat Assoc 90: 106-129.
    • (1995) J Am Stat Assoc , vol.90 , pp. 106-129
    • Robins, J.M.1    Rotnitzky, A.2    Zhao, L.P.3
  • 195
    • 0442278084 scopus 로고    scopus 로고
    • Adjusting for nonignorable drop-out using semi-parametric nonresponse models (with comments)
    • Scharfstein DO, Rotnizky A, Robins JM. 1999. Adjusting for nonignorable drop-out using semi-parametric nonresponse models (with comments). J Am Stat Assoc 94: 1096-1146.
    • (1999) J Am Stat Assoc , vol.94 , pp. 1096-1146
    • Scharfstein, D.O.1    Rotnizky, A.2    Robins, J.M.3
  • 196
    • 84986253560 scopus 로고    scopus 로고
    • Difficulties in demonstrating superiority of an antibiotic for multi-drug resistant bacteria in non-randomized studies
    • Stafford KA, Boutin M, Evans SR, Harris AD. 2014. Difficulties in demonstrating superiority of an antibiotic for multi-drug resistant bacteria in non-randomized studies. CID 59: 1142-1147.
    • (2014) CID , vol.59 , pp. 1142-1147
    • Stafford, K.A.1    Boutin, M.2    Evans, S.R.3    Harris, A.D.4
  • 198
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine-Reporting of subgroup analyses in clinical trials
    • Wang R et al. 2007. Statistics in medicine-Reporting of subgroup analyses in clinical trials. NEJM 357(21): 2189-2194.
    • (2007) NEJM , vol.357 , Issue.21 , pp. 2189-2194
    • Wang, R.1
  • 199
    • 32844471041 scopus 로고    scopus 로고
    • A new paradigm for deriving and analyzing number needed to treat
    • Alemayehu D, Whalen E. 2006. A new paradigm for deriving and analyzing number needed to treat. J Biopharm Stat 16(2): 181-92.
    • (2006) J Biopharm Stat , vol.16 , Issue.2 , pp. 181-192
    • Alemayehu, D.1    Whalen, E.2
  • 200
    • 0032494717 scopus 로고    scopus 로고
    • Confidence intervals for the number needed to treat
    • Altman DG. 1998. Confidence intervals for the number needed to treat. Br Med J 317: 1309-1312.
    • (1998) Br Med J , vol.317 , pp. 1309-1312
    • Altman, D.G.1
  • 201
    • 0033524123 scopus 로고    scopus 로고
    • Calculating the number needed to treat where the outcome is time to an event
    • Altman DG, Andersen PK. 1999. Calculating the number needed to treat where the outcome is time to an event. Br Med J 319: 1492-1495.
    • (1999) Br Med J , vol.319 , pp. 1492-1495
    • Altman, D.G.1    Andersen, P.K.2
  • 202
    • 65849268320 scopus 로고    scopus 로고
    • Aspirin in the primary and secondary prevention of vascular disease: Collaborative meta-analysis of individual participant data from randomised trials
    • Antithrombotic Trialists’ (ATT) Collaboration. 2009. Aspirin in the primary and secondary prevention of vascular disease: Collaborative meta-analysis of individual participant data from randomised trials. Lancet 373: 1849-1860.
    • (2009) Lancet , vol.373 , pp. 1849-1860
  • 203
    • 0003572415 scopus 로고
    • Suite 303, Colborne Building 3, Victoria Hospital, 375 South Street, London ON N6A 4G5, Canada
    • Bellamy N. 1995. WOMAC User’s Guide, Suite 303, Colborne Building 3, Victoria Hospital, 375 South Street, London ON N6A 4G5, Canada.
    • (1995) WOMAC User’s Guide
    • Bellamy, N.1
  • 204
    • 29844450031 scopus 로고    scopus 로고
    • Number needed to treat (NNT)
    • 2nd edn., P. Armitageand T. Colton (eds.). Chichester, UK: Wiley
    • Bender R. 2005. Number needed to treat (NNT). In Encyclopedia of Biostatistics, 2nd edn., P. Armitageand T. Colton (eds.). Chichester, UK: Wiley. Vol. 6, pp. 3752-3761.
    • (2005) Encyclopedia of Biostatistics , vol.6 , pp. 3752-3761
    • Bender, R.1
  • 206
    • 0028221952 scopus 로고
    • A new proposal for benefit-less risk analysis in clinical trials
    • Chuang-Stein C. 1994. A new proposal for benefit-less risk analysis in clinical trials. Controlled Clin Trials 15: 30-43.
    • (1994) Controlled Clin Trials , vol.15 , pp. 30-43
    • Chuang-Stein, C.1
  • 207
    • 44649167607 scopus 로고    scopus 로고
    • Measures for conducting comparative benefit: Risk assessment
    • Chuang-Stein C, Entsuah R, Pritchett Y. 2008. Measures for conducting comparative benefit: risk assessment. Drug Inf J 42: 3: 223-233.
    • (2008) Drug Inf J , vol.42 , Issue.3 , pp. 223-233
    • Chuang-Stein, C.1    Entsuah, R.2    Pritchett, Y.3
  • 208
    • 0025913637 scopus 로고
    • Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials
    • Chuang-Stein C, Mohberg NR, Sinkula MS. 1991. Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials. Stat Med 10: 1349-1359.
    • (1991) Stat Med , vol.10 , pp. 1349-1359
    • Chuang-Stein, C.1    Mohberg, N.R.2    Sinkula, M.S.3
  • 209
    • 85123142150 scopus 로고    scopus 로고
    • Getting personal
    • February
    • Clarke B. February 2010. Getting personal. Int Clin Trials (15): 16-21.
    • (2010) Int Clin Trials , Issue.15 , pp. 16-21
    • Clarke, B.1
  • 211
    • 0029739081 scopus 로고    scopus 로고
    • Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: An Eastern Cooperative Oncology Group study
    • Cole BF, Gelber RD, Kirkwood JM. 1996. Quality-of-life-adjusted survival analysis of interferon alfa-2b adjuvant treatment of high-risk resected cutaneous melanoma: An Eastern Cooperative Oncology Group study. J Clin Oncol 14: 2666-2673.
    • (1996) J Clin Oncol , vol.14 , pp. 2666-2673
    • Cole, B.F.1    Gelber, R.D.2    Kirkwood, J.M.3
  • 212
    • 0028908929 scopus 로고
    • The number needed to treat: A clinically useful measure of treatment effect
    • Cook RJ, Sackett DL. 1995. The number needed to treat: A clinically useful measure of treatment effect. BMJ 310: 452-454.
    • (1995) BMJ , vol.310 , pp. 452-454
    • Cook, R.J.1    Sackett, D.L.2
  • 213
    • 21044448108 scopus 로고    scopus 로고
    • Bias of estimate of number needed to treat
    • Duncan BW, Olkin I. 2005. Bias of estimate of number needed to treat. Stat Med 24: 1837-1848.
    • (2005) Stat Med , vol.24 , pp. 1837-1848
    • Duncan, B.W.1    Olkin, I.2
  • 214
    • 63849288816 scopus 로고    scopus 로고
    • Safe drugs and the cost of good intentions
    • Eichler HG, Abadie E, Raine JM, Salmonson T. 2009. Safe drugs and the cost of good intentions. NEJM 360: 14: 1378-1380.
    • (2009) NEJM , vol.360 , Issue.14 , pp. 1378-1380
    • Eichler, H.G.1    Abadie, E.2    Raine, J.M.3    Salmonson, T.4
  • 216
    • 44649174352 scopus 로고    scopus 로고
    • Benefit: Risk evaluation in clinical trials
    • Evans SR. 2008. Benefit: risk evaluation in clinical trials. Drug Inf J 42(3): 221.
    • (2008) Drug Inf J , vol.42 , Issue.3 , pp. 221
    • Evans, S.R.1
  • 219
    • 84903836051 scopus 로고    scopus 로고
    • A randomized trial evaluating Prosaptide™ for HIV-associated sensory neuropathies: Use of an electronic diary to record neuropathic pain
    • Evans SR, Simpson D, Kitch DW, King A, Clifford DB, Cohen BA, McArthur JC. 2007. A randomized trial evaluating Prosaptide™ for HIV-associated sensory neuropathies: Use of an electronic diary to record neuropathic pain. PLoS ONE 2(7): e551. doi: 10.1371/journal.pone.0000551.
    • (2007) PLoS ONE , vol.2 , Issue.7 , pp. e551
    • Evans, S.R.1    Simpson, D.2    Kitch, D.W.3    King, A.4    Clifford, D.B.5    Cohen, B.A.6    McArthur, J.C.7
  • 220
    • 85123135218 scopus 로고    scopus 로고
    • Federal Coordinating Council for Comparative Effectiveness Research, HHS (FCC for CER). 2009. Report to the President and the Congress. http://www.hhs.gov/recovery/programs/cer/cerannualrpt.pdf.
    • (2009) Report to the President and the Congress
  • 221
    • 52649135630 scopus 로고    scopus 로고
    • Identifying and addressing safety signals in clinical trials
    • Fleming T. 2008. Identifying and addressing safety signals in clinical trials. NEJM 359(13): 1400-1402.
    • (2008) NEJM , vol.359 , Issue.13 , pp. 1400-1402
    • Fleming, T.1
  • 222
    • 0037202567 scopus 로고    scopus 로고
    • Regression analysis based on pairwise ordering of patients’ clinical histories
    • Follman D. 2002. Regression analysis based on pairwise ordering of patients’ clinical histories. Stat Med 21: 3353-3367.
    • (2002) Stat Med , vol.21 , pp. 3353-3367
    • Follman, D.1
  • 224
    • 68149132770 scopus 로고    scopus 로고
    • Estimating the number needed to treat from continuous outcomes in randomised controlled trials: Methodological challenges and worked example using data from the UK Back Pain Exercise and Manipulation (BEAM) trial
    • Froud R, Eldridge S, Lall R, Underwood M. 2009. Estimating the number needed to treat from continuous outcomes in randomised controlled trials: Methodological challenges and worked example using data from the UK Back Pain Exercise and Manipulation (BEAM) trial. BMC Med Res Methodol 9: 35.
    • (2009) BMC Med Res Methodol , vol.9 , pp. 35
    • Froud, R.1    Eldridge, S.2    Lall, R.3    Underwood, M.4
  • 225
    • 0024462761 scopus 로고
    • A quality-of-life oriented endpoint for comparing treatments
    • Gelber RD, Gelman RS, Goldhirsch A. 1989. A quality-of-life oriented endpoint for comparing treatments. Biometrics 45: 781-795.
    • (1989) Biometrics , vol.45 , pp. 781-795
    • Gelber, R.D.1    Gelman, R.S.2    Goldhirsch, A.3
  • 226
    • 0026081121 scopus 로고
    • A statistical comparison of durg safety in safety in controlled clinical trials: The genie score as an objective measure of lab abnormalities
    • Gilbert GS, Ting N, Zubkoff L. 1991. A statistical comparison of durg safety in safety in controlled clinical trials: The genie score as an objective measure of lab abnormalities. Drug Inf J 25: 81-96.
    • (1991) Drug Inf J , vol.25 , pp. 81-96
    • Gilbert, G.S.1    Ting, N.2    Zubkoff, L.3
  • 228
    • 11344274277 scopus 로고    scopus 로고
    • The number needed to treat: A useful clinical measure or a case of the Emperor’s new clothes?
    • Grieve A. 2003. The number needed to treat: A useful clinical measure or a case of the Emperor’s new clothes? Pharm Stat 2: 87-102.
    • (2003) Pharm Stat , vol.2 , pp. 87-102
    • Grieve, A.1
  • 229
    • 77952482465 scopus 로고    scopus 로고
    • Illustrating rating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache
    • Haas M, Schneider M, Vavrek D. 2010. Illustrating rating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat 18: 9.
    • (2010) Chiropr Osteopat , vol.18 , pp. 9
    • Haas, M.1    Schneider, M.2    Vavrek, D.3
  • 230
    • 34447555783 scopus 로고    scopus 로고
    • Current assessment of risk-benefit by regulators: Is it time to introduce decision analysis?
    • Hughes DA, Bayoumi AM, Pirmohamed M. 2007. Current assessment of risk-benefit by regulators: Is it time to introduce decision analysis? Clin Pharmacol Ther 82: 2: 123-127.
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 123-127
    • Hughes, D.A.1    Bayoumi, A.M.2    Pirmohamed, M.3
  • 231
    • 0034354086 scopus 로고    scopus 로고
    • Number needed to treat: Properties and problems
    • Hutton JL. 2000. Number needed to treat: Properties and problems. J R Stat Soc 163: 403-419.
    • (2000) J R Stat Soc , vol.163 , pp. 403-419
    • Hutton, J.L.1
  • 235
    • 85123141764 scopus 로고    scopus 로고
    • International Conference on Harmonization
    • ICH 2c. 2012. Periodic benefit-risk evaluation report, International Conference on Harmonization.
    • (2012) Periodic benefit-risk evaluation report
  • 237
    • 85123135277 scopus 로고    scopus 로고
    • International Conference on Harmonization
    • ICH 2e. 2004. Pharmacovigilance planning, International Conference on Harmonization.
    • (2004) Pharmacovigilance planning
  • 241
    • 34548575455 scopus 로고    scopus 로고
    • Limitations of applying summary results of clinical trials to individual patients: The need for risk stratification
    • Kent DM, Hayward RA. 2007. Limitations of applying summary results of clinical trials to individual patients: The need for risk stratification. JAMA 298: 10: 1209-1212.
    • (2007) JAMA , vol.298 , Issue.10 , pp. 1209-1212
    • Kent, D.M.1    Hayward, R.A.2
  • 242
    • 33745929924 scopus 로고    scopus 로고
    • Time-to-event analyses for long-term treatments-The APPROVe Trial
    • Lagakos SW. 2006. Time-to-event analyses for long-term treatments-The APPROVe Trial. NEJM 355(2): 113-117.
    • (2006) NEJM , vol.355 , Issue.2 , pp. 113-117
    • Lagakos, S.W.1
  • 243
  • 244
    • 0032890561 scopus 로고    scopus 로고
    • Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: Application to highly cited trials in cardiovascular medicine
    • Mancini GBJ, Schulzer M. 1999. Reporting risks and benefits of therapy by use of the concepts of unqualified success and unmitigated failure: Application to highly cited trials in cardiovascular medicine. Circulation 99: 377-383.
    • (1999) Circulation , vol.99 , pp. 377-383
    • Mancini, G.B.J.1    Schulzer, M.2
  • 246
    • 51649085327 scopus 로고    scopus 로고
    • The “number needed to treat” turns 20-And continues to be used and misused
    • McAlister FA. 2008. The “number needed to treat” turns 20-And continues to be used and misused. CMAJ 179(6): 549-553.
    • (2008) CMAJ , vol.179 , Issue.6 , pp. 549-553
    • McAlister, F.A.1
  • 247
    • 1242341330 scopus 로고    scopus 로고
    • Benefits and harms associated with hormone replacement therapy: Clinical decision analysis
    • Minelli C, Abrams KR, Sutton AJ, Cooper NJ. 2004. Benefits and harms associated with hormone replacement therapy: Clinical decision analysis. BMJ 328: 371.
    • (2004) BMJ , vol.328 , pp. 371
    • Minelli, C.1    Abrams, K.R.2    Sutton, A.J.3    Cooper, N.J.4
  • 248
    • 84864819168 scopus 로고    scopus 로고
    • A longitudinal model and graphic for benefit-risk analysis, with case study
    • Norton JD. 2011. A longitudinal model and graphic for benefit-risk analysis, with case study. Drug Inf J 45: 741-747.
    • (2011) Drug Inf J , vol.45 , pp. 741-747
    • Norton, J.D.1
  • 249
    • 85123151313 scopus 로고    scopus 로고
    • Are cholesterol drugs a good idea for healthy people?
    • March 2010
    • O’Callaghan T. 2010. Are cholesterol drugs a good idea for healthy people? Time, March 2010, http://healthland.time.com/2010/03/31/are-cholesterol-drugs-a-good-idea-for-healthy-people.
    • (2010) Time
    • O’Callaghan, T.1
  • 250
    • 44649133246 scopus 로고    scopus 로고
    • A perspective on characterizing benefits and risks derived from clinical trials: Can we do more?
    • O’Neil RT. 2007. A perspective on characterizing benefits and risks derived from clinical trials: Can we do more? Drug Inf J 42: 3: 235-245.
    • (2007) Drug Inf J , vol.42 , Issue.3 , pp. 235-245
    • O’Neil, R.T.1
  • 251
    • 0016527308 scopus 로고
    • A survey of the benefits and risks in the practice of radiology
    • Payne JT, Loken. MK. 1975. A survey of the benefits and risks in the practice of radiology. CRC Crit Rev Clin Radiol Nucl Med 6: 425-439.
    • (1975) CRC Crit Rev Clin Radiol Nucl Med , vol.6 , pp. 425-439
    • Payne, J.T.1    Loken, M.K.2
  • 252
    • 33645881922 scopus 로고    scopus 로고
    • The charisma of subgroups and the subgroups of CHARISMA
    • 354
    • Pfeffer MA, Jarcho JA. 2006. The charisma of subgroups and the subgroups of CHARISMA. NEJM 354; 16: 20: 1744-1746.
    • (2006) NEJM , vol.16 , Issue.20 , pp. 1744-1746
    • Pfeffer, M.A.1    Jarcho, J.A.2
  • 253
    • 52649127401 scopus 로고    scopus 로고
    • The application of global benefit-risk assessment in clinical trial design and some statistical considerations
    • Pritchett Y, Tamura R. 2008. The application of global benefit-risk assessment in clinical trial design and some statistical considerations. Pharm Stat 7: 170-178.
    • (2008) Pharm Stat , vol.7 , pp. 170-178
    • Pritchett, Y.1    Tamura, R.2
  • 254
    • 84865482221 scopus 로고    scopus 로고
    • Improved Neuropsychological and Neurological Functioning Across Three Antiretroviral Regimens in Diverse Resource-Limited Settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study
    • Robertson et al. 2012. Improved Neuropsychological and Neurological Functioning Across Three Antiretroviral Regimens in Diverse Resource-Limited Settings: AIDS Clinical Trials Group Study A5199, the International Neurological Study. CID 55(6): 868-876.
    • (2012) CID , vol.55 , Issue.6 , pp. 868-876
    • Robertson1
  • 256
    • 3142744004 scopus 로고    scopus 로고
    • Number needed to treat estimates incorporating effects over the entire range of clinical outcomes
    • Savor JL. 2004. Number needed to treat estimates incorporating effects over the entire range of clinical outcomes. Arch Neurol 61: 1066-1070.
    • (2004) Arch Neurol , vol.61 , pp. 1066-1070
    • Savor, J.L.1
  • 257
    • 33749618085 scopus 로고    scopus 로고
    • Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease
    • Schneider LS, Tariat PN, Dagerman KS. 2006. Effectiveness of atypical antipsychotic drugs in patients with Alzheimer’s disease. N Engl J Med 355: 1528-1538.
    • (2006) N Engl J Med , vol.355 , pp. 1528-1538
    • Schneider, L.S.1    Tariat, P.N.2    Dagerman, K.S.3
  • 258
    • 33750629336 scopus 로고    scopus 로고
    • Joint distribution approaches to simultaneously quantifying benefit and risk
    • Shaffer ML, Watterberg KL. 2006. Joint distribution approaches to simultaneously quantifying benefit and risk. BMC Med Res Methodol 6: 48.
    • (2006) BMC Med Res Methodol , vol.6 , pp. 48
    • Shaffer, M.L.1    Watterberg, K.L.2
  • 259
    • 0035962354 scopus 로고    scopus 로고
    • Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours
    • Shakespeare TP, Gebski VJ, Veness MJ, Simes J. 2001. Improving interpretation of clinical studies by use of confidence levels, clinical significance curves, and risk-benefit contours. Lancet 357: 1349-1353.
    • (2001) Lancet , vol.357 , pp. 1349-1353
    • Shakespeare, T.P.1    Gebski, V.J.2    Veness, M.J.3    Simes, J.4
  • 260
    • 75149190882 scopus 로고    scopus 로고
    • Statistical methods to analyze adverse events data of randomized clincial trials
    • Siddiqui O. 2009. Statistical methods to analyze adverse events data of randomized clincial trials. J Biopharm Stat 19: 889-899.
    • (2009) J Biopharm Stat , vol.19 , pp. 889-899
    • Siddiqui, O.1
  • 261
    • 34447561715 scopus 로고    scopus 로고
    • Quantitative decision analysis: A work in progress
    • Temple R. 2007. Quantitative decision analysis: A work in progress. Clin Pharmacol Ther 82: 2: 127-130.
    • (2007) Clin Pharmacol Ther , vol.82 , Issue.2 , pp. 127-130
    • Temple, R.1
  • 262
    • 0141974142 scopus 로고    scopus 로고
    • A closer look at the distribution of number needed to treat (NNT): A Bayesian approach
    • Thabane L. 2003. A closer look at the distribution of number needed to treat (NNT): A Bayesian approach. Biostatistics 4: 3: 365-370.
    • (2003) Biostatistics , vol.4 , Issue.3 , pp. 365-370
    • Thabane, L.1
  • 263
    • 33751584603 scopus 로고    scopus 로고
    • Adaptive dose selection using efficacy-toxicity trade-offs: Illustrations and practical considerations
    • Thall PF, Cook JD, Estey EH. 2006. Adaptive dose selection using efficacy-toxicity trade-offs: Illustrations and practical considerations. J Biopharm Stat 16: 623-638.
    • (2006) J Biopharm Stat , vol.16 , pp. 623-638
    • Thall, P.F.1    Cook, J.D.2    Estey, E.H.3
  • 264
    • 0035977439 scopus 로고    scopus 로고
    • Number needed to treat (NNT) estimation of a measure of clinical benefit
    • Walter SD. 2001. Number needed to treat (NNT) estimation of a measure of clinical benefit. Stat Med 20: 3947-3962.
    • (2001) Stat Med , vol.20 , pp. 3947-3962
    • Walter, S.D.1
  • 265
    • 0035970781 scopus 로고    scopus 로고
    • Estimating the number needed to treat (NNT) index when the data are subject to error
    • Walter SD, Irwig L. 2001. Estimating the number needed to treat (NNT) index when the data are subject to error. Stat Med 20: 893-906.
    • (2001) Stat Med , vol.20 , pp. 893-906
    • Walter, S.D.1    Irwig, L.2
  • 266
    • 33645998383 scopus 로고    scopus 로고
    • Novel methods for multivariate ordinal data applied to olympic medals, risk profiles, genomic pathways, genetic diplotypes, pattern sensitivity, and array normalization
    • Wittkowski K. 2004. Novel methods for multivariate ordinal data applied to olympic medals, risk profiles, genomic pathways, genetic diplotypes, pattern sensitivity, and array normalization. Comput Sci Stat 35: 626-646.
    • (2004) Comput Sci Stat , vol.35 , pp. 626-646
    • Wittkowski, K.1
  • 267
    • 0032534738 scopus 로고    scopus 로고
    • Statistical reviewing for medical journals
    • Altman DG. 1998. Statistical reviewing for medical journals. Stat Med 17: 2661-2674.
    • (1998) Stat Med , vol.17 , pp. 2661-2674
    • Altman, D.G.1
  • 268
    • 0000862163 scopus 로고    scopus 로고
    • Improving doctors’ understanding of statistics
    • Altman DG, Bland JM. 1998. Improving doctors’ understanding of statistics. J R Stat Soc A 154: 223-267.
    • (1998) J R Stat Soc A , vol.154 , pp. 223-267
    • Altman, D.G.1    Bland, J.M.2
  • 269
    • 0034712491 scopus 로고    scopus 로고
    • Subgroup analysis and other (mis)uses of baselin data in clinical trials
    • Assman SF, Pocock SJ, Enos LE, Kasten LE. 2000. Subgroup analysis and other (mis)uses of baselin data in clinical trials. Lancet 355: 1064-1069.
    • (2000) Lancet , vol.355 , pp. 1064-1069
    • Assman, S.F.1    Pocock, S.J.2    Enos, L.E.3    Kasten, L.E.4
  • 270
    • 0023878385 scopus 로고
    • Guidelines for statistical reporting in articles for medical journals
    • Bailar JC, Mosteller F. 1988. Guidelines for statistical reporting in articles for medical journals. Ann Intern Med 108: 266-273.
    • (1988) Ann Intern Med , vol.108 , pp. 266-273
    • Bailar, J.C.1    Mosteller, F.2
  • 272
    • 0037422847 scopus 로고    scopus 로고
    • Standards for reporting of diagnostic accuracy. Toward complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. Standards for reporting of diagnostic accuracy
    • Bossuyt PM, Reitsma JB, Bruns DE Gatsonis PP, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, De Vet HC. 2003. Standards for reporting of diagnostic accuracy. Toward complete and accurate reporting of studies of diagnostic accuracy: The STARD initiative. Standards for reporting of diagnostic accuracy. Ann Intern Med 138: 40-44.
    • (2003) Ann Intern Med , vol.138 , pp. 40-44
    • Bossuyt, P.M.1    Reitsma, J.B.2    Bruns, D.E.3    Gatsonis, P.P.4    Glasziou, P.P.5    Irwig, L.M.6    Lijmer, J.G.7    Moher, D.8    Rennie, D.9    De Vet, H.C.10
  • 273
    • 77955506490 scopus 로고    scopus 로고
    • Outcome reporting among drug trials registered in clinicaltrials.gov
    • Bourgeois FT, Murthy S, Mandl KD. 2010. Outcome reporting among drug trials registered in clinicaltrials.gov. Ann Intern Med 153: 158-166.
    • (2010) Ann Intern Med , vol.153 , pp. 158-166
    • Bourgeois, F.T.1    Murthy, S.2    Mandl, K.D.3
  • 274
    • 77952787734 scopus 로고    scopus 로고
    • Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes
    • Boutron I, Dutton S, Ravaud P, Altman DG. 2010. Reporting and interpretation of randomized controlled trials with statistically nonsignificant results for primary outcomes. JAMA 303(20): 2058-2064.
    • (2010) JAMA , vol.303 , Issue.20 , pp. 2058-2064
    • Boutron, I.1    Dutton, S.2    Ravaud, P.3    Altman, D.G.4
  • 275
    • 0025913637 scopus 로고
    • Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials
    • Chuang-Stein C, Mohberg NR, Sinkula MS. 1991. Three measures for simultaneously evaluating benefits and risks using categorical data from clinical trials. Stat Med 10: 1349-1359.
    • (1991) Stat Med , vol.10 , pp. 1349-1359
    • Chuang-Stein, C.1    Mohberg, N.R.2    Sinkula, M.S.3
  • 277
    • 78951480208 scopus 로고    scopus 로고
    • Development of a framework for enhancing the transparency, reproducibility, and communication of the benefit-risk balance of medicines
    • Coplan PM, Noel RA, Levitan BS, Feguson J, Mussen F. 2011. Development of a framework for enhancing the transparency, reproducibility, and communication of the benefit-risk balance of medicines. Clin Pharmacol Ther 89(2): 312-315.
    • (2011) Clin Pharmacol Ther , vol.89 , Issue.2 , pp. 312-315
    • Coplan, P.M.1    Noel, R.A.2    Levitan, B.S.3    Feguson, J.4    Mussen, F.5
  • 278
    • 1442354597 scopus 로고    scopus 로고
    • Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: The TREND statement
    • Des Jarlais DC, Lyles C, Crepaz N. 2004. Improving the reporting quality of nonrandomized evaluations of behavioral and public health interventions: The TREND statement. Am J Public Health 94(3): 361-366.
    • (2004) Am J Public Health , vol.94 , Issue.3 , pp. 361-366
    • Des Jarlais, D.C.1    Lyles, C.2    Crepaz, N.3
  • 279
    • 77953059620 scopus 로고    scopus 로고
    • Common statistical concerns in clinical trials
    • Evans SR. 2010. Common statistical concerns in clinical trials. J Exp Stroke Transl Med 3(1): 1-7.
    • (2010) J Exp Stroke Transl Med , vol.3 , Issue.1 , pp. 1-7
    • Evans, S.R.1
  • 281
    • 0018878995 scopus 로고
    • How to detect, correct and prevent errors in the medical literature
    • Glantz SA. 1980. How to detect, correct and prevent errors in the medical literature. Biostatistics 61: 1-7.
    • (1980) Biostatistics , vol.61 , pp. 1-7
    • Glantz, S.A.1
  • 282
    • 0034595229 scopus 로고    scopus 로고
    • Claims of equivalence in medical research: Are they supported by the evidence?
    • Greene WL, Concato J, Feinstein AR. 2000. Claims of equivalence in medical research: Are they supported by the evidence? Ann Intern Med 132: 715-722.
    • (2000) Ann Intern Med , vol.132 , pp. 715-722
    • Greene, W.L.1    Concato, J.2    Feinstein, A.R.3
  • 283
    • 27644579038 scopus 로고    scopus 로고
    • Statistical methods in the journal (letter)
    • Horton NJ, Switzer SS. 2005. Statistical methods in the journal (letter). N Engl J Med 353: 1977-1979.
    • (2005) N Engl J Med , vol.353 , pp. 1977-1979
    • Horton, N.J.1    Switzer, S.S.2
  • 285
    • 0023805341 scopus 로고
    • Randomized trial of intravenous strptokinase, oral aspirin, both, or neither among 17, 187 cases of suspected acute myocardial infarction: ISIS-2
    • ISIS-2 Collaborative Study Group. 1988. Randomized trial of intravenous strptokinase, oral aspirin, both, or neither among 17, 187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 2(8607): 349-360.
    • (1988) Lancet , vol.2 , Issue.8607 , pp. 349-360
  • 286
    • 33745929924 scopus 로고    scopus 로고
    • Time-to-event analyses for long-term treatments-The APPROVe Trial
    • Lagakos SW. 2006. Time-to-event analyses for long-term treatments-The APPROVe Trial. NEJM 355(2): 113-117.
    • (2006) NEJM , vol.355 , Issue.2 , pp. 113-117
    • Lagakos, S.W.1
  • 288
    • 84864819168 scopus 로고    scopus 로고
    • A longitudinal model and graphic for benefit: Risk analysis with case study
    • Norton JD. 2011. A longitudinal model and graphic for benefit: risk analysis with case study. Drug Inf J 45: 741-747.
    • (2011) Drug Inf J , vol.45 , pp. 741-747
    • Norton, J.D.1
  • 289
    • 33644792767 scopus 로고    scopus 로고
    • Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement
    • Piaggio G, Elbourne DR, Altman DG, Pocock SJ, Evans SJW. 2006. Reporting of noninferiority and equivalence randomized trials: An extension of the CONSORT statement. JAMA 295: 1152-1160.
    • (2006) JAMA , vol.295 , pp. 1152-1160
    • Piaggio, G.1    Elbourne, D.R.2    Altman, D.G.3    Pocock, S.J.4    Evans, S.J.W.5
  • 290
    • 84859005251 scopus 로고    scopus 로고
    • Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study
    • Prayle AP, Hurley MN, Smyth AR. 2011. Compliance with mandatory reporting of clinical trial results on ClinicalTrials.gov: Cross sectional study. BMJ 344: d7373. doi: 10.1136/bmj.d7373.
    • (2011) BMJ , vol.344 , pp. d7373
    • Prayle, A.P.1    Hurley, M.N.2    Smyth, A.R.3
  • 291
    • 84862955602 scopus 로고    scopus 로고
    • Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis
    • Ross JS, Tse T, Zarin DA, Xu H, Zhou L, Krumholz HM. 2011. Publication of NIH funded trials registered in ClinicalTrials.gov: Cross sectional analysis. BMJ 344: d7292. doi: 10.1136/bmj.d7292.
    • (2011) BMJ , vol.344 , pp. d7292
    • Ross, J.S.1    Tse, T.2    Zarin, D.A.3    Xu, H.4    Zhou, L.5    Krumholz, H.M.6
  • 292
    • 36348939350 scopus 로고    scopus 로고
    • Statistics in medicine-reporting of subgroup analyses in clinical trials
    • Wang R, Lagakos SW, Ware JH, Hunter DJ, Drazen JM. 2007. Statistics in medicine-reporting of subgroup analyses in clinical trials. N Engl J Med 357(21): 2189-2194.
    • (2007) N Engl J Med , vol.357 , Issue.21 , pp. 2189-2194
    • Wang, R.1    Lagakos, S.W.2    Ware, J.H.3    Hunter, D.J.4    Drazen, J.M.5
  • 293
    • 0019277715 scopus 로고
    • An assessment of physician knowledge of epidemiology and biostatistics
    • Weiss ST, Samet JM. 1980. An assessment of physician knowledge of epidemiology and biostatistics. J Med Educ 55: 692-697.
    • (1980) J Med Educ , vol.55 , pp. 692-697
    • Weiss, S.T.1    Samet, J.M.2
  • 294
    • 34547630893 scopus 로고    scopus 로고
    • Clinician attitudes towards biostatistics
    • West CP, Ficalora RD. 2007. Clinician attitudes towards biostatistics. Mayo Clin Proc 82: 939-943.
    • (2007) Mayo Clin Proc , vol.82 , pp. 939-943
    • West, C.P.1    Ficalora, R.D.2
  • 295
    • 34548426480 scopus 로고    scopus 로고
    • Medicine residents’ understanding of the biostatistics and results in he medical literature
    • Windish DM, Huot SJ, Free ML. 2007. Medicine residents’ understanding of the biostatistics and results in he medical literature. JAMA 298: 1010-1022.
    • (2007) JAMA , vol.298 , pp. 1010-1022
    • Windish, D.M.1    Huot, S.J.2    Free, M.L.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.