Planning of clinical trials

Journal of Internal Medicine

Volumn 255, Issue 4, 2004, Pages 427-438

  Boissel, J P ^a  

^a UNIVERSITÉ LYON 1   (France)

Author keywords

Clinical trial; Methodology

Indexed keywords

ARTICLE; CLINICAL PROTOCOL; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DATA ANALYSIS; HYPOTHESIS; INFORMATION PROCESSING; INFORMATION RETRIEVAL; METHODOLOGY; PLANNING; PRACTICE GUIDELINE; PRIORITY JOURNAL; QUALITY CONTROL; RANDOMIZED CONTROLLED TRIAL; SAMPLE SIZE; SCIENTIFIC LITERATURE; STATISTICAL ANALYSIS; TECHNIQUE; VALIDATION PROCESS;

CONTROL GROUPS; DOUBLE-BLIND METHOD; HUMANS; MODELS, BIOLOGICAL; RANDOM ALLOCATION; RANDOMIZED CONTROLLED TRIALS; RESEARCH DESIGN; SAMPLE SIZE; STATISTICS;

EID: 1842454173     PISSN: 09546820     EISSN: None     Source Type: Journal    
DOI: 10.1111/j.1365-2796.2004.01311.x     Document Type: Article

References (34)

1. Bernard C. Introduction à l'étude de la mèdecine expérimentale. Paris: Baillère, 1865.
2. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutical trials. J Chronic Dis 1967; 20: 637-48.
3. Huth EJ. Needed: review articles with more scientific rigour. Ann Intern Med 1987; 106: 470-1.
4. Grilli R, Magrini N, Penna A, Mura G, Liberati A. Practice guidelines developed by specialty societies: the need for a critical appraisal. Lancet 2000; 355: 103-6.
5. Moore TC. Deadly Medicine. New York: Simon & Schuster. 1995.
6. Kahan JP, Neu CR, Hamons GT, Illman BJ. The Decision to Initiate Clinical Trials of Current Medical Practices. Santa Monica, CA: Rand Corporation, 1985.
7. Freiman JA, Chalmers TC, Smith H, Kuebler RR. The importance of beta, the type II error and sample size in the design and interpretation of the randomized control trial: survey of 71 negative trials. New Engl J Med 1978; 299: 690-4.
8. Lachin JM. Introduction to sample size determination and power analysis for clinical trials. Control Clin Trials 1981; 2: 93-113.
9. Garret AD. Therapeutic equivalence: fallacies and falsification. Stat Med 2003; 22: 741-62.
10. Boissel JP, Collet JP, Moleur P, Haugh M. Surrogate endpoints: a basis for a rational approach. Eur J Clin Pharmacol 1992; 43: 235-44.
11. Buyse M, Molenberghs G. The validation of surrogate endpoints in randomized experiments. Biometrics 1998; 54: 1014-29.
12. Yusuf S, Collins R, Peto R. Why do we need some large, simple randomized trials? Stat Med 1984; 3: 409-20.
13. ISIS-2 (Second International Study of Infarct Survival) Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both, or neither among 17 187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988; ii: 349-60.
14. The EMIP Group. Pre-hospital thrombolytic therapy in patients with suspected acute myocardial infarction. N Engl J Med 1993; 329: 383-9.
15. Moseley JB, O'Malley K, Petersen NJ et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002; 347: 81-8.
16. Cochran WG, Cox GM. Experimental Designs. New York: Wiley & Sons, 1957.
17. Armitage P. Statistical Methods in Medical Research. Oxford: Blackwell, 1971.
18. Collet J-P, Boissel J-P and the VALIDATA Group. Sick population-treated population: the need for a better definition. Eur J Clin Pharmacol 1991; 41: 489-91.
19. Boissel JP, Peyrieux JC and the EPSIM Research Group. Sub-grouping of post myocardial infarction patients according to their one-year death risk. Eur Heart J 1987; 8: 1272-80.
20. Boissel JP, Leizorovicz A, Picolet H, Ducruet T and the APSI investigators. Efficacy of acebutolol after acute myocardial infarction (The APSI Trial). Am J Cardiol 1990; 66: 24-31.
21. The EPSIM Research Group. Controlled comparison of aspirin and oral anticoagulants in prevention of death after myocardial infarction. N Engl J Med 1982; 307: 701-8.
22. Boissel JP, Collet JP, Lièvre M, Girard P. An effect model for the assessment of drug benefit: example of antiarrhythmic drugs in postmyocardial infarction patients. J Cardiovasc Pharmacol 1993; 22: 356-63.
23. Boissel J-P, Gueyffier F, Haugh M. Response to 'Inclusion of Women and Minorities in Clinical Trials and the NIH Revitalization Act of 1993 - the perspective of NIH Clinical Trialists'. Control Clin Trials 1995; 16: 286-8.
24. Boissel JP. Individualizing aspirin therapy for prevention of cardiovascular events. JAMA 1998; 280: 1949-50.
25. Boissel JP, Gueyffier F, Cucherat M, Bricca G. Pharmacogenetics and responders to a therapy: theoretical background and practical problems. Clin Chem Lab Med 2003; 41: 564-72.
26. Meinert CL. Quality assurance in clinical trials. In: Boissel JP, Klimt CR, eds. Multicenter Controlled Trials: Principles and Problems. Paris: Inserm, 1979; 123-30.
27. Meier P. Terminating a trial - the ethical problem. Clin Pharmacol Therap 1979; 25: 633-40.
28. Canner PL. Monitoring clinical trial data for evidence of adverse or beneficial treatment. In: Boissel JP, Klimt CR, eds. Multicenter Controlled Trials: Principles and Problems. Paris: Inserm, 1979; 131-50.
29. Armitage P. Sequential Medical Trials. Oxford: Blackwell, 1975.
30. Pocock SJ. Group sequential methods in the design and analysis of clinical trials. Biometrika 1977; 64; 191-9.
31. DeMets DL, Lan KK. Interim analysis: the alpha spending function approach. Stat Med 1994; 13: 1341-52.
32. 2 DeMets DL, Ware JH. Asymmetric group sequential boundaries for monitoring clinical trials. Biometrika 1982; 69; 661-3.
33. Friedman LM, Furberg CD, DeMets DL. Fundamentals of Clinical Trials. Boston: John Wright PSG, 1981.
34. Pocock SJ. Clinical Trials: A Practical Approach. Chichester: Wiley & Sons, 1990.