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Volumn 83, Issue SPEC. ISS. C, 2004, Pages

New developments in medical clinical trials

Author keywords

Clinical trials; Study analysis; Study conduct; Study design

Indexed keywords

CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; HUMAN; METHODOLOGY; MULTICENTER STUDY; PROFESSIONAL STANDARD; RANDOMIZED CONTROLLED TRIAL; REVIEW;

EID: 4143150945     PISSN: 00220345     EISSN: None     Source Type: Journal    
DOI: 10.1177/154405910408301S04     Document Type: Conference Paper
Times cited : (14)

References (47)
  • 1
    • 0033565436 scopus 로고    scopus 로고
    • Longitudinal data analysis (repeated measures) in clinical trials
    • Albert PS (1999). Longitudinal data analysis (repeated measures) in clinical trials. Stat Med 18;1707-1732.
    • (1999) Stat Med , vol.18 , pp. 1707-1732
    • Albert, P.S.1
  • 2
    • 0032894129 scopus 로고    scopus 로고
    • Data and safety monitoring in the Concorde and Alpha trials
    • Armitage P (1999a). Data and safety monitoring in the Concorde and Alpha trials. Controlled Clin Trials 20:207-228.
    • (1999) Controlled Clin Trials , vol.20 , pp. 207-228
    • Armitage, P.1
  • 3
    • 0032919460 scopus 로고    scopus 로고
    • Data and safety monitoring in the Delta trials
    • Armitage P (1999b). Data and safety monitoring in the Delta trials. Controlled Clin Trials 20:229-241.
    • (1999) Controlled Clin Trials , vol.20 , pp. 229-241
    • Armitage, P.1
  • 4
    • 0028832009 scopus 로고
    • Clinical trial data and safety monitoring boards. The search for a constitution
    • Armstrong PW, Furberg CD (1995). Clinical trial data and safety monitoring boards. The search for a constitution. Circulation 91:901-904.
    • (1995) Circulation , vol.91 , pp. 901-904
    • Armstrong, P.W.1    Furberg, C.D.2
  • 6
    • 0032526166 scopus 로고    scopus 로고
    • Extending the simple linear regression model to account for correlated responses: An introduction to generalized estimating equation techniques and multi-level mixed modeling
    • Burton P, Gurin L, Sly P (1998). Extending the simple linear regression model to account for correlated responses: an introduction to generalized estimating equation techniques and multi-level mixed modeling. Stat Med 17:1261-1291.
    • (1998) Stat Med , vol.17 , pp. 1261-1291
    • Burton, P.1    Gurin, L.2    Sly, P.3
  • 7
    • 0031708453 scopus 로고    scopus 로고
    • Criteria for the validation of surrogate endpoints in randomized experiments
    • Buyse M, Molenberghs G (1998). Criteria for the validation of surrogate endpoints in randomized experiments. Biometrics 54:1014-1029.
    • (1998) Biometrics , vol.54 , pp. 1014-1029
    • Buyse, M.1    Molenberghs, G.2
  • 8
    • 0035005121 scopus 로고    scopus 로고
    • Recent advances in the analysis and presentation of safety data
    • Chuang-Stein C, Le V, Chen W (2001). Recent advances in the analysis and presentation of safety data. J Drug Inform Assoc 35:377-397.
    • (2001) J Drug Inform Assoc , vol.35 , pp. 377-397
    • Chuang-Stein, C.1    Le, V.2    Chen, W.3
  • 9
    • 0030670430 scopus 로고    scopus 로고
    • Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data
    • Cnaan A, Laird NM, Slasor P (1997). Using the general linear mixed model to analyse unbalanced repeated measures and longitudinal data. Stat Med 16:2349-2380.
    • (1997) Stat Med , vol.16 , pp. 2349-2380
    • Cnaan, A.1    Laird, N.M.2    Slasor, P.3
  • 10
  • 11
    • 0034732220 scopus 로고    scopus 로고
    • Controlling alpha in a clinical trial: The case for secondary endpoints
    • D'Agostino RB Sr (2000). Controlling alpha in a clinical trial: the case for secondary endpoints (editorial). Stat Med 19:763-766.
    • (2000) Stat Med , vol.19 , pp. 763-766
    • D'Agostino Sr., R.B.1
  • 12
    • 0025976240 scopus 로고
    • Multiple comparisons in over-the-counter drug clinical trials with both positive and placebo controls
    • D'Agostino RB, Heeren TC (1991). Multiple comparisons in over-the-counter drug clinical trials with both positive and placebo controls. Stat Med 10:1-6.
    • (1991) Stat Med , vol.10 , pp. 1-6
    • D'Agostino, R.B.1    Heeren, T.C.2
  • 13
    • 0027934302 scopus 로고
    • Interim analysis: The alpha spending function approach
    • DeMets DL, Lan KKG (1994). Interim analysis: the alpha spending function approach. Stat Med 13:1341-1352.
    • (1994) Stat Med , vol.13 , pp. 1341-1352
    • DeMets, D.L.1    Lan, K.K.G.2
  • 15
    • 0032528867 scopus 로고    scopus 로고
    • Practical issues in equivalency trials
    • Ebbutt AF, Frith L (1998). Practical issues in equivalency trials. Stat Med 17:1691-1701.
    • (1998) Stat Med , vol.17 , pp. 1691-1701
    • Ebbutt, A.F.1    Frith, L.2
  • 16
    • 0029932955 scopus 로고    scopus 로고
    • Intent-to-treat versus as-treated analysis
    • Ellenberg JH (1996). Intent-to-treat versus as-treated analysis. J Drug Inform Assoc 30:535-544.
    • (1996) J Drug Inform Assoc , vol.30 , pp. 535-544
    • Ellenberg, J.H.1
  • 17
    • 0034687076 scopus 로고    scopus 로고
    • Placebo-controlled trials and active controlled trials in the evaluation of new treatment. Part 2: Practical issues and specific cases
    • Ellenberg SS, Temple R (2000). Placebo-controlled trials and active controlled trials in the evaluation of new treatment. Part 2: practical issues and specific cases. Ann Intern Med 133:464-470.
    • (2000) Ann Intern Med , vol.133 , pp. 464-470
    • Ellenberg, S.S.1    Temple, R.2
  • 18
    • 0032971979 scopus 로고    scopus 로고
    • Carvedilol and the Food and Drug Administration (FDA) approval process: The FDA paradigm and reflections on hypothesis testing
    • Fisher LD (1999). Carvedilol and the Food and Drug Administration (FDA) approval process: the FDA paradigm and reflections on hypothesis testing. Controlled Clin Trials 20:16-39.
    • (1999) Controlled Clin Trials , vol.20 , pp. 16-39
    • Fisher, L.D.1
  • 19
    • 0033011501 scopus 로고    scopus 로고
    • Carvedilol and the Food and Drug Administration approval process: An introduction
    • Fisher LD, Moye LA (1999). Carvedilol and the Food and Drug Administration approval process: an introduction. Controlled Clin Trials 20:1-15.
    • (1999) Controlled Clin Trials , vol.20 , pp. 1-15
    • Fisher, L.D.1    Moye, L.A.2
  • 20
    • 0030268577 scopus 로고    scopus 로고
    • Surrogate end points in clinical trials: Are we being misled?
    • Fleming TR, DeMets DL (1996). Surrogate end points in clinical trials: are we being misled? Ann Intern Med 125:605-613.
    • (1996) Ann Intern Med , vol.125 , pp. 605-613
    • Fleming, T.R.1    DeMets, D.L.2
  • 21
    • 0028273049 scopus 로고
    • Surrogate and auxiliary endpoints in clinical trials, with potential applications in cancer and AIDS research
    • Fleming TR, Prentice RL, Pepe MS, Glidden D (1994). Surrogate and auxiliary endpoints in clinical trials, with potential applications in cancer and AIDS research. Stat Med 13:955-968.
    • (1994) Stat Med , vol.13 , pp. 955-968
    • Fleming, T.R.1    Prentice, R.L.2    Pepe, M.S.3    Glidden, D.4
  • 23
    • 0026573094 scopus 로고
    • Statistical validation of intermediate endpoints for chronic diseases
    • Freedman LS, Graubard BI, Schatzkin A (1992). Statistical validation of intermediate endpoints for chronic diseases. Stat Med 11:167-178.
    • (1992) Stat Med , vol.11 , pp. 167-178
    • Freedman, L.S.1    Graubard, B.I.2    Schatzkin, A.3
  • 24
    • 0034045316 scopus 로고    scopus 로고
    • Evaluation of safety data from controlled clinical trials: The clinical principles explained
    • Gait JE, Smith S, Brown SL (2000). Evaluation of safety data from controlled clinical trials: the clinical principles explained. J Drug Inform Assoc 34:273-287.
    • (2000) J Drug Inform Assoc , vol.34 , pp. 273-287
    • Gait, J.E.1    Smith, S.2    Brown, S.L.3
  • 25
    • 0035003536 scopus 로고    scopus 로고
    • Statistical methods for comparison to placebo in active-control trials
    • Hasselblad V, Kong DF (2001). Statistical methods for comparison to placebo in active-control trials. Drug Inform J 35:435-449.
    • (2001) Drug Inform J , vol.35 , pp. 435-449
    • Hasselblad, V.1    Kong, D.F.2
  • 26
    • 0033004225 scopus 로고    scopus 로고
    • Some issues in design and analysis of equivalence trials
    • Hauck WW, Anderson S (1999). Some issues in design and analysis of equivalence trials. J Drug Inform Assoc 33:109-118.
    • (1999) J Drug Inform Assoc , vol.33 , pp. 109-118
    • Hauck, W.W.1    Anderson, S.2
  • 27
    • 0032694404 scopus 로고    scopus 로고
    • Design issues in noninferiority/equivalence trials
    • Hwang IK, Morikawa T (1999). Design issues in noninferiority/equivalence trials. J Drug Inform Assoc 33:1205-1218.
    • (1999) J Drug Inform Assoc , vol.33 , pp. 1205-1218
    • Hwang, I.K.1    Morikawa, T.2
  • 31
    • 0034045125 scopus 로고    scopus 로고
    • Blinded sample size re-estimation in multi-armed clinical trials
    • Kieser M, Friede T (2000). Blinded sample size re-estimation in multi-armed clinical trials. J Drug Inform Assoc 34:455-460.
    • (2000) J Drug Inform Assoc , vol.34 , pp. 455-460
    • Kieser, M.1    Friede, T.2
  • 32
    • 0034731878 scopus 로고    scopus 로고
    • Alpha calculus in a clinical trial: Consideration and commentary for the new millennium
    • Koch GG (2000). Alpha calculus in a clinical trial: consideration and commentary for the new millennium (discussion). Stat Med 19:781-784.
    • (2000) Stat Med , vol.19 , pp. 781-784
    • Koch, G.G.1
  • 33
    • 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 Clin Trials 21:167-189.
    • (2000) Controlled Clin Trials , vol.21 , pp. 167-189
    • Lachin, J.M.1
  • 34
    • 0032972732 scopus 로고    scopus 로고
    • End-point interpretation in clinical trials: The case for discipline
    • Moye LA (1999). End-point interpretation in clinical trials: the case for discipline. Controlled Clin Trials 20:40-49.
    • (1999) Controlled Clin Trials , vol.20 , pp. 40-49
    • Moye, L.A.1
  • 35
    • 0343673950 scopus 로고    scopus 로고
    • Alpha calculus in a clinical trial: Consideration and commentary for the new millennium
    • Moye LA (2000). Alpha calculus in a clinical trial: consideration and commentary for the new millennium. Stat Med 19:767-789.
    • (2000) Stat Med , vol.19 , pp. 767-789
    • Moye, L.A.1
  • 36
    • 0034089435 scopus 로고    scopus 로고
    • Handling missing data in clinical trials: An overview
    • Myers WR (2000). Handling missing data in clinical trials: an overview. J Drug Inform Assoc 34:525-533.
    • (2000) J Drug Inform Assoc , vol.34 , pp. 525-533
    • Myers, W.R.1
  • 37
  • 38
    • 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
  • 39
    • 0034731876 scopus 로고    scopus 로고
    • Alpha calculus in clinical trials: Considerations and commentary for the new millennium
    • O'Neill RT (2000). Alpha calculus in clinical trials: considerations and commentary for the new millennium (commentary). Stat Med 19:785-793.
    • (2000) Stat Med , vol.19 , pp. 785-793
    • O'Neill, R.T.1
  • 40
    • 0024520844 scopus 로고
    • Surrogate endpoints in clinical trials: Definition and operational criteria
    • Prentice RL (1989). Surrogate endpoints in clinical trials: definition and operational criteria. Stat Med 8:431-440.
    • (1989) Stat Med , vol.8 , pp. 431-440
    • Prentice, R.L.1
  • 41
    • 0032960273 scopus 로고    scopus 로고
    • Multiple imputation: A primer
    • Schafer JL (1999). Multiple imputation: a primer. Stat Methods Med Res 8:3-15.
    • (1999) Stat Methods Med Res , vol.8 , pp. 3-15
    • Schafer, J.L.1
  • 42
    • 0030965969 scopus 로고    scopus 로고
    • Testing for treatment differences with dropouts present in clinical trials - A composite approach
    • Shih WJ, Quan H (1997). Testing for treatment differences with dropouts present in clinical trials - a composite approach. Stat Med 16:1225-1239.
    • (1997) Stat Med , vol.16 , pp. 1225-1239
    • Shih, W.J.1    Quan, H.2
  • 43
    • 0031729840 scopus 로고    scopus 로고
    • A comparison of the random-effects pattern mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts
    • Siddiqui O, Ali MW (1998). A comparison of the random-effects pattern mixture model with last-observation-carried-forward (LOCF) analysis in longitudinal clinical trials with dropouts. J Biopharmaceut Stat 8:545-563.
    • (1998) J Biopharmaceut Stat , vol.8 , pp. 545-563
    • Siddiqui, O.1    Ali, M.W.2
  • 44
    • 0003077113 scopus 로고
    • A regulatory authority's opinion about surrogate endpoints
    • Nimmo WS, Tucker GT, editors. New York: Wiley
    • Temple RJ (1995). A regulatory authority's opinion about surrogate endpoints. In: Clinical measurement in drug evaluation. Nimmo WS, Tucker GT, editors. New York: Wiley.
    • (1995) Clinical Measurement in Drug Evaluation
    • Temple, R.J.1
  • 45
    • 0034687072 scopus 로고    scopus 로고
    • Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Part 1: Ethical and scientific issues
    • Temple R, Ellenberg SS (2000). Placebo-controlled trials and active-controlled trials in the evaluation of new treatments. Part 1: ethical and scientific issues. Ann Intern Med 133:455-463.
    • (2000) Ann Intern Med , vol.133 , pp. 455-463
    • Temple, R.1    Ellenberg, S.S.2
  • 46
    • 0034994805 scopus 로고    scopus 로고
    • The practical use of different strategies to handle dropouts in longitudinal studies
    • Verbeke G, LeSaffre E, Spiessens B (2001). The practical use of different strategies to handle dropouts in longitudinal studies. J Drug Inform Assoc 35:419-434.
    • (2001) J Drug Inform Assoc , vol.35 , pp. 419-434
    • Verbeke, G.1    Lesaffre, E.2    Spiessens, B.3
  • 47
    • 0024502084 scopus 로고
    • Surrogate endpoints in clinical trials: Cardiovascular disease
    • Wittes J, Lakatos E, Probstfeld J (1989). Surrogate endpoints in clinical trials: cardiovascular disease. Stat Med 8:415-425.
    • (1989) Stat Med , vol.8 , pp. 415-425
    • Wittes, J.1    Lakatos, E.2    Probstfeld, J.3


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.