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Volumn , Issue , 2012, Pages

Clinical Trials Handbook: Design and Conduct

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EID: 84891584996     PISSN: None     EISSN: None     Source Type: Book    
DOI: 10.1002/9781118422878     Document Type: Book
Times cited : (11)

References (104)
  • 1
    • 62849112328 scopus 로고    scopus 로고
    • Alzheimer's Disease Anti-inflammatory Prevention Trial: Design, methods, and baseline results
    • ADAPT Research Group
    • ADAPT Research Group: Alzheimer's Disease Anti-inflammatory Prevention Trial: Design, methods, and baseline results. Alzheimer's & Dementia 2009; 5: 93-104.
    • (2009) Alzheimer's & Dementia , vol.5 , pp. 93-104
  • 2
    • 0020315031 scopus 로고
    • A program for balancing the allocation of subjects to treatment in a clinical trial
    • Aickin M: A program for balancing the allocation of subjects to treatment in a clinical trial. Computers and Biomedical Research 1982; 15: 519-524.
    • (1982) Computers and Biomedical Research , vol.15 , pp. 519-524
    • Aickin, M.1
  • 6
    • 0025862281 scopus 로고
    • A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest: Design, methods and patient characteristics
    • Brain Resuscitation Clinical Trial II Study Group
    • Brain Resuscitation Clinical Trial II Study Group: A randomized clinical trial of calcium entry blocker administration to comatose survivors of cardiac arrest: Design, methods and patient characteristics. Control Clin Trials 1991; 12: 525-545.
    • (1991) Control Clin Trials , vol.12 , pp. 525-545
  • 7
    • 0025598872 scopus 로고
    • The run-in period in clinical trials
    • Brittain E, Wittes J: The run-in period in clinical trials. Control Clin Trials 1990; 11: 327-338.
    • (1990) Control Clin Trials , vol.11 , pp. 327-338
    • Brittain, E.1    Wittes, J.2
  • 9
    • 1842540786 scopus 로고
    • Monitoring clinical trial data for evidence of adverse or beneficial treatment effects
    • Canner PL: Monitoring clinical trial data for evidence of adverse or beneficial treatment effects. INSERM 1977; 76: 131-149.
    • (1977) INSERM , vol.76 , pp. 131-149
    • Canner, P.L.1
  • 10
    • 0024321898 scopus 로고
    • Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction
    • Cardiac Arrhythmia Suppression Trial (CAST) Investigators
    • Cardiac Arrhythmia Suppression Trial (CAST) Investigators: Preliminary report: Effect of encainide and flecainide on mortality in a randomized trial of arrhythmia suppression after myocardial infarction. N Engl J Med 1989; 321: 406-412.
    • (1989) N Engl J Med , vol.321 , pp. 406-412
  • 11
    • 0033012176 scopus 로고    scopus 로고
    • The Childhood Asthma Management Program (CAMP): Design, rationale, and methods
    • Childhood Asthma Management Program Research Group
    • Childhood Asthma Management Program Research Group: The Childhood Asthma Management Program (CAMP): Design, rationale, and methods. Control Clin Trials 1999; 20: 91-120.
    • (1999) Control Clin Trials , vol.20 , pp. 91-120
  • 12
    • 44949171503 scopus 로고    scopus 로고
    • Adaptive design methods in clinical trials-A review
    • Chow S-C, Chang M: Adaptive design methods in clinical trials-A review. Orphanet J Rare Dis 2008 3:11.
    • (2008) Orphanet J Rare Dis , vol.3 , pp. 11
    • Chow, S.-C.1    Chang, M.2
  • 13
    • 0028866278 scopus 로고
    • The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06
    • Christian MC, McCabe MS, Korn EL, Abrams JS, Kaplan RS, Friedman MA: The National Cancer Institute audit of the National Surgical Adjuvant Breast and Bowel Project Protocol B-06. N Eng J Med 1995; 333: 1469-1574.
    • (1995) N Eng J Med , vol.333 , pp. 1469-1574
    • Christian, M.C.1    McCabe, M.S.2    Korn, E.L.3    Abrams, J.S.4    Kaplan, R.S.5    Friedman, M.A.6
  • 14
    • 0014624185 scopus 로고
    • The Bayesian outlook and its application (including discussion by S Geisser, HO Hartley, O Kempthrone, H Rubin)
    • Cornfield J: The Bayesian outlook and its application (including discussion by S Geisser, HO Hartley, O Kempthrone, H Rubin). Biometrics 1969; 25: 617-657.
    • (1969) Biometrics , vol.25 , pp. 617-657
    • Cornfield, J.1
  • 15
    • 0002516459 scopus 로고
    • Sequential trials, sequential analysis and the likelihood principle
    • Cornfield J: Sequential trials, sequential analysis and the likelihood principle. Am Statistician 1966; 20: 18-23.
    • (1966) Am Statistician , vol.20 , pp. 18-23
    • Cornfield, J.1
  • 16
    • 0018962999 scopus 로고
    • Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project
    • Coronary Drug Project Research Group
    • Coronary Drug Project Research Group: Influence of adherence to treatment and response of cholesterol on mortality in the Coronary Drug Project. N Engl J Med 1980; 303: 1038-1041.
    • (1980) N Engl J Med , vol.303 , pp. 1038-1041
  • 17
    • 0017137743 scopus 로고
    • Aspirin in coronary heart disease
    • Coronary Drug Project Research Group
    • Coronary Drug Project Research Group: Aspirin in coronary heart disease. J Chron Dis 1976; 29: 625-642.
    • (1976) J Chron Dis , vol.29 , pp. 625-642
  • 18
    • 0015593704 scopus 로고
    • The Coronary Drug Project: Design, methods, and baseline results
    • Coronary Drug Project Research Group
    • Coronary Drug Project Research Group: The Coronary Drug Project: Design, methods, and baseline results. Circulation 1973; 47(Suppl I):I-1-I-50.
    • (1973) Circulation , vol.47 , Issue.SUPPL I , pp. 1-50
  • 19
    • 57149146140 scopus 로고    scopus 로고
    • National Emphysema Treatment Trial
    • Criner GJ Editor
    • Criner GJ Editor: National Emphysema Treatment Trial. (compendium of 34 parts ) Proc Am Thorac Soc 2008; 5: 379-574.
    • (2008) (compendium of 34 parts ) Proc Am Thorac Soc , vol.5 , pp. 379-574
  • 20
    • 0022405991 scopus 로고
    • A Test of the National Death Index Using the Coronary Artery Surgery Study (CASS)
    • Davis KB, Fisher L, Gillespie MJ, Pettinger M: A Test of the National Death Index Using the Coronary Artery Surgery Study (CASS). Control Clin Trials 6: 179-191, 1985.
    • (1985) Control Clin Trials , vol.6 , pp. 179-191
    • Davis, K.B.1    Fisher, L.2    Gillespie, M.J.3    Pettinger, M.4
  • 23
    • 0027934302 scopus 로고
    • Interim analysis: The alpha spending function approach
    • DeMets DL, Lan KKG: Interim analysis: The alpha spending function approach. Stat Med 1994; 13: 1341-1352.
    • (1994) Stat Med , vol.13 , pp. 1341-1352
    • DeMets, D.L.1    Lan, K.K.G.2
  • 24
    • 1542319172 scopus 로고    scopus 로고
    • HIPAA Administrative Simplification: Standard Unique Health Identifier for Health Care Providers (final rule)
    • Department of Health and Human Services
    • Department of Health and Human Services: HIPAA Administrative Simplification: Standard Unique Health Identifier for Health Care Providers (final rule). Federal Register 23 January 2004; 69: 3434-3469.
    • (2004) Federal Register 23 January , vol.69 , pp. 3434-3469
  • 25
    • 84887175431 scopus 로고    scopus 로고
    • Standards for privacy of individually identifiable health information (Unofficial version) (45 CFR Parts 160 and 164): Regulation text (28 Dec 2000: as amended: Part 160 (31 May 2002); Parts 160, 164 (14 Aug 2002); 31 pages; Oct
    • Department of Health and Human Services; Office for Civil Rights
    • Department of Health and Human Services; Office for Civil Rights: Standards for privacy of individually identifiable health information (Unofficial version) (45 CFR Parts 160 and 164): Regulation text (28 Dec 2000: as amended: Part 160 (31 May 2002); Parts 160, 164 (14 Aug 2002); 31 pages; Oct 2002.
    • (2002) , pp. 31
  • 26
    • 33644524168 scopus 로고
    • Diabetic Retinopathy Study: Report Number 6
    • Diabetic Retinopathy Study Research Group
    • Diabetic Retinopathy Study Research Group: Diabetic Retinopathy Study: Report Number 6. Design, methods, and baseline results. Invest Ophthalmol Vis Sci 1981; 21: 149-209.
    • (1981) Design, methods, and baseline results. Invest Ophthalmol Vis Sci , vol.21 , pp. 149-209
  • 27
    • 4243828610 scopus 로고
    • Informative drop-out in longitudinal data analysis
    • Diggle P, Kenward MG: Informative drop-out in longitudinal data analysis. Appl Statist 1994; 43: 49-93.
    • (1994) Appl Statist , vol.43 , pp. 49-93
    • Diggle, P.1    Kenward, M.G.2
  • 28
    • 0009663357 scopus 로고
    • A multiple comparison procedure for comparing several treatments with a control
    • Dunnett CW: A multiple comparison procedure for comparing several treatments with a control. JASA 1955; 50: 1096-1121.
    • (1955) JASA , vol.50 , pp. 1096-1121
    • Dunnett, C.W.1
  • 29
    • 0020533586 scopus 로고    scopus 로고
    • Sequential stopping rules and sequentially adjusted p-values; Does one require the other? Control Clin Trials 1983; 4: 3-10
    • Dupont WD: Sequential stopping rules and sequentially adjusted p-values; Does one require the other? Control Clin Trials 1983; 4: 3-10.
    • Dupont, W.D.1
  • 30
    • 0004029170 scopus 로고
    • Likelihood: An account of the Statistical Likelihood Concept of Likelihood and its Application to Scientific Inference
    • Cambridge University Press, Cambridge
    • Edwards AWF: Likelihood: An account of the Statistical Likelihood Concept of Likelihood and its Application to Scientific Inference. Cambridge University Press, Cambridge, 1972.
    • (1972)
    • Edwards, A.W.F.1
  • 31
    • 0003577283 scopus 로고
    • Code of Federal Regulations; 21
    • Food and Drug Administration, Parts 300-499, Revised as of April 1, Office of the Federal Register, National Archives and Records Administration, Washington, 1994
    • Food and Drug Administration: Code of Federal Regulations; 21, Parts 300-499, Revised as of April 1, 1994. Office of the Federal Register, National Archives and Records Administration, Washington, 1994.
    • (1994)
  • 32
    • 0019044714 scopus 로고
    • Deferring consent with incompetent patients in an intensive care unit
    • Fost N, Robertson JA: Deferring consent with incompetent patients in an intensive care unit. IRB 1980; 2(7): 5-6.
    • (1980) IRB , vol.2 , Issue.7 , pp. 5-6
    • Fost, N.1    Robertson, J.A.2
  • 33
    • 0023185342 scopus 로고
    • Equipoise and the ethics of clinical research
    • Freedman B: Equipoise and the ethics of clinical research. N Engl J Med 1987; 317: 141-145.
    • (1987) N Engl J Med , vol.317 , pp. 141-145
    • Freedman, B.1
  • 35
    • 0025776644 scopus 로고
    • The Glaucoma Laser Trial (GLT): 3
    • Glaucoma Laser Trial Research Group
    • Glaucoma Laser Trial Research Group: The Glaucoma Laser Trial (GLT): 3. Design and methods. Control Clin Trials 1991; 12: 504-524.
    • (1991) Design and methods. Control Clin Trials , vol.12 , pp. 504-524
  • 37
    • 0018579580 scopus 로고
    • Five-year findings of the Hypertension Detection and Follow-up Program: I
    • Hypertension Detection and Follow-up Program Cooperative Group
    • Hypertension Detection and Follow-up Program Cooperative Group: Five-year findings of the Hypertension Detection and Follow-up Program: I. Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA 1979; 242: 2562-2571.
    • (1979) Reduction in mortality of persons with high blood pressure, including mild hypertension. JAMA , vol.242 , pp. 2562-2571
  • 38
    • 0013488890 scopus 로고
    • The Hypertension Prevention Trial (HPT): Design, Methods, and Baseline Results
    • Hypertension Prevention Trial Research Group, (C Meinert, J Tonascia, S Tonascia, editors)
    • Hypertension Prevention Trial Research Group: The Hypertension Prevention Trial (HPT): Design, Methods, and Baseline Results (C Meinert, J Tonascia, S Tonascia, editors). Control Clin Trials 1989; 10(Suppl):1S-117S.
    • (1989) Control Clin Trials , vol.10 , Issue.SUPPL
  • 39
    • 0014683352 scopus 로고
    • Definition of ''sole contribution''
    • Ingelfinger FJ: Definition of ''sole contribution''. Engl J Med 1969; 281: 676-677.
    • (1969) Engl J Med , vol.281 , pp. 676-677
    • Ingelfinger, F.J.1
  • 40
    • 0013485680 scopus 로고
    • Review of the Fialuridine (FIAU) Clinical Trials
    • Institute of Medicine Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials, National Academy Press, Washington
    • Institute of Medicine Committee to Review the Fialuridine (FIAU/FIAC) Clinical Trials: Review of the Fialuridine (FIAU) Clinical Trials. National Academy Press, Washington, 1995.
    • (1995)
  • 41
    • 0031584064 scopus 로고    scopus 로고
    • Uniform requirements for manuscripts submitted to biomedical journals
    • International Committee of Medical Journal Editors
    • International Committee of Medical Journal Editors: Uniform requirements for manuscripts submitted to biomedical journals. N Engl J Med 1997; 336: 309-315.
    • (1997) N Engl J Med , vol.336 , pp. 309-315
  • 42
    • 0003857352 scopus 로고
    • Experimentation with Human Beings
    • Russell Sage Foundation, New York
    • Katz J: Experimentation with Human Beings. Russell Sage Foundation, New York, 1972.
    • (1972)
    • Katz, J.1
  • 44
    • 0019800734 scopus 로고
    • Design and Methodological Considerations in the National Cooperative Gallstone Study: A Multicenter Clinical Trial
    • The NCGS Protocol Committee ( Tyor MP, Bennett PH, Grundy SM, Hardison WGM, Shaw LW, Thistle JL, Vlahcevic ZR, and The National Cooperative Gallstone Study Group)
    • Lachin JM, Marks JW, Schoenfield LJ, and The NCGS Protocol Committee ( Tyor MP, Bennett PH, Grundy SM, Hardison WGM, Shaw LW, Thistle JL, Vlahcevic ZR, and The National Cooperative Gallstone Study Group): Design and Methodological Considerations in the National Cooperative Gallstone Study: A Multicenter Clinical Trial. Control Clin Trials 1981; 2: 177-230.
    • (1981) Control Clin Trials , vol.2 , pp. 177-230
    • Lachin, J.M.1    Marks, J.W.2    Schoenfield, L.J.3
  • 47
    • 0003424636 scopus 로고
    • Ethics and Regulation of Clinical Research
    • 2nd ed. Yale University Press, New Haven
    • Levine RJ: Ethics and Regulation of Clinical Research, 2nd ed. Yale University Press, New Haven, 1988.
    • (1988)
    • Levine, R.J.1
  • 48
    • 0020513189 scopus 로고
    • Argon laser photocoagulation for ocular histoplasmosis: Results of a randomized clinical trial
    • Macular Photocoagulation Study Group
    • Macular Photocoagulation Study Group: Argon laser photocoagulation for ocular histoplasmosis: Results of a randomized clinical trial. Arch Ophthalmol 1983; 101: 1347-1357.
    • (1983) Arch Ophthalmol , vol.101 , pp. 1347-1357
  • 49
    • 0020609839 scopus 로고
    • Argon laser photocoagulation for ideopathic neovascularization
    • Macular Photocoagulation Study Group
    • Macular Photocoagulation Study Group: Argon laser photocoagulation for ideopathic neovascularization. Results of a randomized clinical trial. Arch Ophthalmol 1983; 101: 1358-1361.
    • (1983) Results of a randomized clinical trial. Arch Ophthalmol , vol.101 , pp. 1358-1361
  • 50
    • 0020027985 scopus 로고
    • Argon laser photocoagulation for senile macular degeneration: Results of a randomized clinical trial
    • Macular Photocoagulation Study Group
    • Macular Photocoagulation Study Group: Argon laser photocoagulation for senile macular degeneration: Results of a randomized clinical trial. Arch Ophthalmol 1982; 100: 912-918.
    • (1982) Arch Ophthalmol , vol.100 , pp. 912-918
  • 51
    • 0036174553 scopus 로고    scopus 로고
    • Double placebo design in a prevention trial for Alzheimer's disease
    • for the ADAPT Research Group
    • Martin BK, Meinert CL, Breitner JCS for the ADAPT Research Group: Double placebo design in a prevention trial for Alzheimer's disease. Control Clin Trials 2002; 23: 93-99.
    • (2002) Control Clin Trials , vol.23 , pp. 93-99
    • Martin, B.K.1    Meinert, C.L.2    Breitner, J.C.S.3
  • 52
    • 84939187269 scopus 로고    scopus 로고
    • Clinical Trials: Design, Conduct, and Analysis
    • 2nd ed. Oxford University Press, New York
    • Meinert CL: Clinical Trials: Design, Conduct, and Analysis, 2nd ed. Oxford University Press, New York, 2012.
    • (2012)
    • Meinert, C.L.1
  • 53
    • 84862497314 scopus 로고    scopus 로고
    • An Insider's Guide to Clinical Trials
    • 279, Oxford University Press, New York
    • Meinert CL: An Insider's Guide to Clinical Trials (279 pages). Oxford University Press, New York, 2011.
    • (2011)
    • Meinert, C.L.1
  • 54
    • 0033557253 scopus 로고    scopus 로고
    • Redesign of trials under different enrollment mixes
    • Meinert CL: Redesign of trials under different enrollment mixes. Statist Med 1999; 18: 241-251.
    • (1999) Statist Med , vol.18 , pp. 241-251
    • Meinert, C.L.1
  • 55
    • 0032493079 scopus 로고    scopus 로고
    • Masked monitoring in clinical trials-Blind stupidity? N Engl J Med 1998; 338: 1381-1382
    • Meinert CL: Masked monitoring in clinical trials-Blind stupidity? N Engl J Med 1998; 338: 1381-1382.
    • Meinert, C.L.1
  • 56
    • 0032010051 scopus 로고    scopus 로고
    • IRBs and randomized clinical trials
    • Meinert CL: IRBs and randomized clinical trials. IRB 1998; 20: 9-12.
    • (1998) IRB , vol.20 , pp. 9-12
    • Meinert, C.L.1
  • 57
    • 0032430615 scopus 로고    scopus 로고
    • Clinical trials and treatment effects monitoring (with discussion)
    • Meinert CL: Clinical trials and treatment effects monitoring (with discussion). Control Clin Trials 1998; 19: 515-543.
    • (1998) Control Clin Trials , vol.19 , pp. 515-543
    • Meinert, C.L.1
  • 58
    • 84887183781 scopus 로고    scopus 로고
    • Clinical Trials Dictionary: Terminology and Usage Recommendations; The Johns Hopkins Center for Clinical Trials, Baltimore, 1996
    • Meinert CL: Clinical Trials Dictionary: Terminology and Usage Recommendations; The Johns Hopkins Center for Clinical Trials, Baltimore, 1996.
    • Meinert, C.L.1
  • 59
    • 0029843341 scopus 로고    scopus 로고
    • An open letter to the FDA regarding changes in reporting procedures for drugs and biologics proposed in the wake of the FIAU tragedy
    • Meinert CL: An open letter to the FDA regarding changes in reporting procedures for drugs and biologics proposed in the wake of the FIAU tragedy. Control Clin Trials 1996; 17: 273-284.
    • (1996) Control Clin Trials , vol.17 , pp. 273-284
    • Meinert, C.L.1
  • 60
    • 84939187269 scopus 로고    scopus 로고
    • Clinical Trials: Design, Conduct, and Analysis
    • Oxford University Press, New York
    • Meinert CL, Tonascia S: Clinical Trials: Design, Conduct, and Analysis. Oxford University Press, New York, 1986.
    • (1986)
    • Meinert, C.L.1    Tonascia, S.2
  • 61
    • 0019976346 scopus 로고
    • Multiple Risk Factor Intervention Trial
    • Multiple Risk Factor Intervention Trial Research Group
    • Multiple Risk Factor Intervention Trial Research Group: Multiple Risk Factor Intervention Trial. Risk factor changes and mortality results. JAMA 1982; 248: 1465-1477.
    • (1982) Risk factor changes and mortality results. JAMA , vol.248 , pp. 1465-1477
  • 62
    • 0033380191 scopus 로고    scopus 로고
    • Rationale and design of the National Emphysema Treatment Trial (NETT): A prospective randomized trial of lung volume reduction surgery
    • National Emphysema Treatment Trial Research Group
    • National Emphysema Treatment Trial Research Group: Rationale and design of the National Emphysema Treatment Trial (NETT): A prospective randomized trial of lung volume reduction surgery. Chest 1999; 116: 1750-1761.
    • (1999) Chest , vol.116 , pp. 1750-1761
  • 63
    • 84887134700 scopus 로고    scopus 로고
    • Clinical coordinating center for lung volume reduction surgery for emphysema
    • National Heart, Lung, and Blood Institute, RFP-NIH-NHLBI-HR-97-01, Bethesda
    • National Heart, Lung, and Blood Institute: Clinical coordinating center for lung volume reduction surgery for emphysema. RFP-NIH-NHLBI-HR-97-01, Bethesda, 1997.
    • (1997)
  • 64
    • 84887158470 scopus 로고
    • Clinical Coordinating Center for the Study of a Childhood Management Program (CAMP)
    • National Heart, Lung, and Blood Institute, RFP-NIH-NHLBI-HR-90-12, Bethesda
    • National Heart, Lung, and Blood Institute: Clinical Coordinating Center for the Study of a Childhood Management Program (CAMP). RFP-NIH-NHLBI-HR-90-12, Bethesda, 1990.
    • (1990)
  • 65
    • 0029401355 scopus 로고    scopus 로고
    • What's in an oath? J Royal Coll of Phys of London 1995; 29: 518-524
    • Nutton V: What's in an oath? J Royal Coll of Phys of London 1995; 29: 518-524.
    • Nutton, V.1
  • 66
    • 0004214158 scopus 로고
    • Code of Federal Regulations, Title 45: Public Welfare, Part 46: Protection of Human Subjects
    • Office for Protection from Research Risks, Department of Health and Human Services, National Institutes of Health, Bethesda, Md, (revised) 18 June
    • Office for Protection from Research Risks: Code of Federal Regulations, Title 45: Public Welfare, Part 46: Protection of Human Subjects. Department of Health and Human Services, National Institutes of Health, Bethesda, Md, (revised) 18 June 1991.
    • (1991)
  • 67
    • 0018821027 scopus 로고
    • Persantine and aspirin in coronary heart disease
    • Persantine-Aspirin Reinfarction Study Research Group
    • Persantine-Aspirin Reinfarction Study Research Group: Persantine and aspirin in coronary heart disease. Circulation 1980; 62: 449-461.
    • (1980) Circulation , vol.62 , pp. 449-461
  • 68
    • 0024298599 scopus 로고
    • Preliminary report: Findings from the aspirin component of the ongoing Physicians' Health Study
    • Physicians' Health Study Research Group Steering Committee
    • Physicians' Health Study Research Group Steering Committee: Preliminary report: Findings from the aspirin component of the ongoing Physicians' Health Study. N Engl J Med 1988; 318: 262-264.
    • (1988) N Engl J Med , vol.318 , pp. 262-264
  • 69
    • 0003576014 scopus 로고
    • Clinical Trials: A Practical Approach
    • John Wiley and Sons, Chichester
    • Pocock SJ: Clinical Trials: A Practical Approach. John Wiley and Sons, Chichester, 1983.
    • (1983)
    • Pocock, S.J.1
  • 70
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definition and operational criteria
    • Prentice RL: Surrogate endpoints in clinical trials: Definition and operational criteria. Statistics in Medicine 1989; 8: 431-440.
    • (1989) Statistics in Medicine , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 71
    • 0012794373 scopus 로고
    • A sequential decision problem with finite memory
    • Robbins H: A sequential decision problem with finite memory. Proc Natl Acad Sci 1956; 42: 920-923.
    • (1956) Proc Natl Acad Sci , vol.42 , pp. 920-923
    • Robbins, H.1
  • 72
    • 84966203785 scopus 로고
    • Some aspects of the sequential design of experiments
    • Robbins H: Some aspects of the sequential design of experiments. Bull Am Mathematics Soc 1952; 58: 527-535.
    • (1952) Bull Am Mathematics Soc , vol.58 , pp. 527-535
    • Robbins, H.1
  • 73
    • 0029634362 scopus 로고
    • Cultural lag and the Hippocratic Oath
    • Robin ED, McCauley RF: Cultural lag and the Hippocratic Oath. Lacent 1995; 345: 1422-1424.
    • (1995) Lacent , vol.345 , pp. 1422-1424
    • Robin, E.D.1    McCauley, R.F.2
  • 74
    • 0004042466 scopus 로고
    • Management and the Worker
    • John Wiley & Sons, New York
    • Roethlisberger FJ, Dickson WJ: Management and the Worker. John Wiley & Sons, New York, 1964.
    • (1964)
    • Roethlisberger, F.J.1    Dickson, W.J.2
  • 76
    • 0019507465 scopus 로고
    • Chenodiol (chenodeoxycholic acid) for dissolution of gallstones: The National Cooperative Gallstone Study
    • The Steering Committee ( Baum RA, Habig RL, Hanson RF, Hersh T, Hightower NC Jr, Hoffmann AF, Lasser EC, Marks JW, Mekhjian H, Okun R, Schaefer RA, Shaw L, Soloway RD, Thistle JL, Thomas FB, Tyor MP) and the National Cooperative Gallstone Study Group
    • Schoenfield LJ, Lachin JM, The Steering Committee ( Baum RA, Habig RL, Hanson RF, Hersh T, Hightower NC Jr, Hoffmann AF, Lasser EC, Marks JW, Mekhjian H, Okun R, Schaefer RA, Shaw L, Soloway RD, Thistle JL, Thomas FB, Tyor MP) and the National Cooperative Gallstone Study Group: Chenodiol (chenodeoxycholic acid) for dissolution of gallstones: The National Cooperative Gallstone Study. Ann Intern Med 1981; 95: 257-282.
    • (1981) Ann Intern Med , vol.95 , pp. 257-282
    • Schoenfield, L.J.1    Lachin, J.M.2
  • 77
    • 0025831464 scopus 로고
    • Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: Final results of the Systolic Hypertension in the Elderly Program (SHEP)
    • SHEP Cooperative Research Group
    • SHEP Cooperative Research Group: Prevention of stroke by antihypertensive drug treatment in older persons with isolated systolic hypertension: Final results of the Systolic Hypertension in the Elderly Program (SHEP). JAMA 1991; 265: 3255-3294.
    • (1991) JAMA , vol.265 , pp. 3255-3294
  • 78
    • 0027454257 scopus 로고
    • Ethical issues and clinical trials
    • Shimm DS, Spece RG: Ethical issues and clinical trials. Drugs 1993; 46: 579-584.
    • (1993) Drugs , vol.46 , pp. 579-584
    • Shimm, D.S.1    Spece, R.G.2
  • 79
    • 0017743105 scopus 로고
    • Adaptive treatment assignment method and clinical trials
    • Simon R: Adaptive treatment assignment method and clinical trials. Biometrics 1977; 33: 743-749.
    • (1977) Biometrics , vol.33 , pp. 743-749
    • Simon, R.1
  • 80
    • 84887202374 scopus 로고    scopus 로고
    • SOCA General Handbook
    • Studies of the Ocular Complications of AIDS Research Group, accessed (6:38am Saturday) 10 December
    • Studies of the Ocular Complications of AIDS Research Group: SOCA General Handbook, https://jhuccs1.us/soca/SOCAgenhandbook/socagenhndbk.pdf, accessed (6:38am Saturday) 10 December 2011.
    • (2011)
  • 81
    • 0035059340 scopus 로고    scopus 로고
    • The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir CMV Retinitis Trial
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: The ganciclovir implant plus oral ganciclovir versus parenteral cidofovir for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Ganciclovir Cidofovir CMV Retinitis Trial. Am J Ophthalmol 2001; 131: 457-467.
    • (2001) Am J Ophthalmol , vol.131 , pp. 457-467
  • 82
    • 0031468277 scopus 로고    scopus 로고
    • MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Monoclonal Antibody Cytomegalovirus Retinitis Trial
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: MSL-109 adjuvant therapy for cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome: The Monoclonal Antibody Cytomegalovirus Retinitis Trial. Arch Ophthalmol 1997; 115: 1528-1536.
    • (1997) Arch Ophthalmol , vol.115 , pp. 1528-1536
  • 83
    • 1842294582 scopus 로고    scopus 로고
    • Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: The HPMPC Peripheral Cytomegalovirus Retinitis Trial
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group
    • Studies of the Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: Parenteral cidofovir for cytomegalovirus retinitis in patients with AIDS: The HPMPC Peripheral Cytomegalovirus Retinitis Trial. A randomized, controlled trial. Ann Intern Med 1997; 126: 264-274.
    • (1997) A randomized, controlled trial. Ann Intern Med , vol.126 , pp. 264-274
  • 85
    • 27844458643 scopus 로고
    • Studies of ocular complications of AIDS foscarnet-ganciclovir cytomegalovirus retinitis trial: 1
    • Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group (ACTG)
    • Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group (ACTG): Studies of ocular complications of AIDS foscarnet-ganciclovir cytomegalovirus retinitis trial: 1. Rationale, design, and methods. Control Clin Trials 1992; 13: 22-39.
    • (1992) Rationale, design, and methods. Control Clin Trials , vol.13 , pp. 22-39
  • 86
    • 11944275015 scopus 로고
    • Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis
    • Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group
    • Studies of Ocular Complications of AIDS Research Group in collaboration with the AIDS Clinical Trials Group: Mortality in patients with the acquired immunodeficiency syndrome treated with either foscarnet or ganciclovir for cytomegalovirus retinitis. N Engl J Med 1992; 326: 213-220.
    • (1992) N Engl J Med , vol.326 , pp. 213-220
  • 87
    • 0016211783 scopus 로고
    • Minimization: A new method of assigning patients to treatment and control groups
    • Taves DR: Minimization: A new method of assigning patients to treatment and control groups. Clin Pharmacol Ther 1974; 15: 443-453.
    • (1974) Clin Pharmacol Ther , vol.15 , pp. 443-453
    • Taves, D.R.1
  • 88
    • 84887209903 scopus 로고
    • NIH Revitalization Act of 1993
    • United States Congress (103rd; 1st session), 42 USC §, Clinical Research Equity Regarding Women and Minorities; Part I: Women and Minorities as Subjects in Clinical Research
    • United States Congress (103rd; 1st session): NIH Revitalization Act of 1993, 42 USC § 131 (1993); Clinical Research Equity Regarding Women and Minorities; Part I: Women and Minorities as Subjects in Clinical Research. 1993.
    • (1993) , vol.131
  • 89
    • 0020418923 scopus 로고
    • Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VIII. Evaluation of insulin therapy: Final report
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VIII. Evaluation of insulin therapy: Final report. Diabetes 1982; 31(Suppl 5): 1-81.
    • (1982) Diabetes , vol.31 , Issue.SUPPL. 5 , pp. 1-81
  • 90
    • 10544234410 scopus 로고
    • Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VII
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: VII. Mortality and selected nonfatal events with insulin treatment. JAMA 1978; 240: 37-42.
    • (1978) Mortality and selected nonfatal events with insulin treatment. JAMA , vol.240 , pp. 37-42
  • 91
    • 0016410374 scopus 로고
    • A Study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes:V. Evaluation of Phenformin therapy
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: A Study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes:V. Evaluation of Phenformin therapy. Diabetes 1975; 24(Suppl 1): 65-184.
    • (1975) Diabetes , vol.24 , Issue.SUPPL. 1 , pp. 65-184
  • 92
    • 0015216518 scopus 로고
    • Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: IV
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: Effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: IV. A preliminary report on phenformin results. JAMA 1971; 217: 777-784.
    • (1971) A preliminary report on phenformin results. JAMA , vol.217 , pp. 777-784
  • 93
    • 0000559926 scopus 로고
    • A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: 1. Design, methods, and baseline characteristics
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: 1. Design, methods, and baseline characteristics. Diabetes 1970; 19(Suppl 2): 747-783.
    • (1970) Diabetes , vol.19 , pp. 747-783
  • 94
    • 0014914649 scopus 로고
    • A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: II. Mortality results
    • University Group Diabetes Program Research Group
    • University Group Diabetes Program Research Group: A study of the effects of hypoglycemic agents on vascular complications in patients with adult-onset diabetes: II. Mortality results. Diabetes 1970; 19(Suppl 2): 785-830.
    • (1970) Diabetes , vol.19 , Issue.SUPPL. 2 , pp. 785-830
  • 95
    • 0003527849 scopus 로고    scopus 로고
    • Webster's Eleventh New Collegiate Dictionary
    • Merriam-Webster Inc, Springfield, Mass
    • Webster's Eleventh New Collegiate Dictionary. Merriam-Webster Inc, Springfield, Mass, 2009.
    • (2009)
  • 96
    • 0003527849 scopus 로고    scopus 로고
    • Webster's Ninth New Collegiate Dictionary
    • Merriam-Webster Inc, Springfield, Mass
    • Webster's Ninth New Collegiate Dictionary. Merriam-Webster Inc, Springfield, Mass, 1991.
    • (1991)
  • 97
    • 0024262955 scopus 로고
    • Properties of the urn randomization in clinical trials
    • Wei LJ, Lachin JM: Properties of the urn randomization in clinical trials. Control Clin Trials 1988; 9: 345-364.
    • (1988) Control Clin Trials , vol.9 , pp. 345-364
    • Wei, L.J.1    Lachin, J.M.2
  • 98
    • 84950610940 scopus 로고
    • A class of designs for sequential clinical trials
    • Wei LJ: A class of designs for sequential clinical trials. JASA 1977; 72: 382-386.
    • (1977) JASA , vol.72 , pp. 382-386
    • Wei, L.J.1
  • 99
    • 0028610538 scopus 로고
    • The hippocratic oath and ethics in medicine
    • Winau R: The hippocratic oath and ethics in medicine. Forensic Sci Int 1994; 69: 285-289.
    • (1994) Forensic Sci Int , vol.69 , pp. 285-289
    • Winau, R.1
  • 100
    • 0024502084 scopus 로고
    • Surrogate endpoints in clinical trials: Cardiovascular diseases
    • Wittes J, Lakatos E: Surrogate endpoints in clinical trials: Cardiovascular diseases. Statistics in Medicine 1989; 8: 415-425.
    • (1989) Statistics in Medicine , vol.8 , pp. 415-425
    • Wittes, J.1    Lakatos, E.2
  • 101
    • 0029826323 scopus 로고    scopus 로고
    • Design and Baseline Characteristics of Participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study
    • for the AASK Pilot Study Investigators
    • Wright JT Jr, Kusek JW, Toto RD, Lee JY, Agodoa LY, Kirk KA, Randall OS, Glassock R for the AASK Pilot Study Investigators: Design and Baseline Characteristics of Participants in the African American Study of Kidney Disease and Hypertension (AASK) Pilot Study. Control Clin Trials 1996; 16: 3S-16S.
    • (1996) Control Clin Trials , vol.16
    • Wright Jr, J.T.1    Kusek, J.W.2    Toto, R.D.3    Lee, J.Y.4    Agodoa, L.Y.5    Kirk, K.A.6    Randall, O.S.7    Glassock, R.8
  • 102
    • 0025737883 scopus 로고
    • Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials
    • Yusuf S, Wittes J, Probstfield J, Tyroler HA: Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. JAMA 266: 93-98, 1991.
    • (1991) JAMA , vol.266 , pp. 93-98
    • Yusuf, S.1    Wittes, J.2    Probstfield, J.3    Tyroler, H.A.4
  • 104
    • 34247981226 scopus 로고
    • Play the winner rule and the controlled clinical trial
    • Zelen M: Play the winner rule and the controlled clinical trial. JASA 1969; 64: 131-146.
    • (1969) JASA , vol.64 , pp. 131-146
    • Zelen, M.1


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