Disciplined analyses in clinical trials: The dark heart of the matter

Statistical Methods in Medical Research

Volumn 17, Issue 3, 2008, Pages 253-264

  Moyé, Lemuel A ^a  

^a UNIVERSITY OF TEXAS SCHOOL OF PUBLIC HEALTH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CARVEDILOL; PLACEBO;

ANALYTICAL ERROR; ARTICLE; CLINICAL RESEARCH; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONGESTIVE HEART FAILURE; DATA ANALYSIS; DATA COLLECTION METHOD; EFFECT SIZE; EXPLORATORY RESEARCH; HUMAN; METHODOLOGY; PREDICTION; RANDOM SAMPLE; SOCIAL ENVIRONMENT; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; SYSTEMATIC ERROR;

CONTROLLED CLINICAL TRIALS AS TOPIC; HUMANS; PROSPECTIVE STUDIES; RESEARCH DESIGN; SAMPLE SIZE; UNITED STATES;

EID: 48049094783     PISSN: 09622802     EISSN: None     Source Type: Journal    
DOI: 10.1177/0962280207080641     Document Type: Article

References (37)

1. Packer M, Bristow MR, Cohn JN, Colucci WS, Fowler MB, Gilbert EM, Shusterman NH. The effect of carvedilol on morbidity and mortality in patients with chronic heart failure. New England Journal of Medicine 1996; 334: 1349-55.
2. Fisher L. Carvedilol and the FDA approval process: the FDA paradigm and reflections upon hypothesis testing. Controlled Clinical Trials 1999; 20: 16-39.
3. Moyé LA, Abernethy D. Carvedilot in patients with chronic heart failure (Letter). New England Journal of Medicine 1996; 335: 1318-19.
4. Packer M, Cohn JN, Colucci WS. Response to Moyé and Abernethy. New England Journal of Medicine 1996; 335: 1318-19.
5. Fisher LD, Moyé LA. Carvedilol and the food and drug administration approval process: an introduction. Controlled Clinical Trials 1999; 20: 1-15.
6. Moyé LA. P Value interpretation in clinical trials. The case for discipline. Controlled Clinical Trials 1999; 20: 40-9.
7. Fisher LD. Carvedilol and the Food and Drug Administration-Approval Process: a brief response to Professor Moyé's article. Controlled Clinical Trials 1999; 20: 50-1.
8. Moyé LA. Statistical reasoning in medicine: the intuitive P-value primer. Springer-Verlag, 2000.
9. Moyé LA. Random research. Circulation 2000; 103: 3150-3.
10. MRFIT Investigators. Multiple risk factor intervention trial. Journal of the American Medical Association 1982; 248: 1465-77.
11. Feldman AM, Bristow MR, Parmley MW, Carson PE, Pepine CJ, Gilbert EM, Strobeck JE, Hendrix GH, Powers ER, Bain RP, White BG, for The Vesnarinone Study Group. Effects of vesnarinone on morbidity and mortality in patients with heart failure. New England Journal of Medicine 1993; 329: 149-55.
12. Cohn JN, Goldstein SO, Greenberg BH, Lorell BH, Bourge RC, Jaski BE, Gottlieb SO, McGrew F, DeMets DL, White BG, for The Vesnarinone Trial Investigators. A dose dependent increase in mortality seen with vesnarinone among patients with severe heart failure. New England Journal of Medicine 1998; 339: 1810-16.
13. MRFIT Investigators. Multiple risk factor intervention trial. Journal of the American Medical Association 1982; 248: 1465-77.
14. Pitt B, Poole-Wilson P, Segal R, Martinez F, Dickstein K, Camm A, Konstam M, Riegger G, Klinger G, Neaton G. Effect of losartan compared with captoprit on mortality in patients with symptomatic heart failure randomized trial-The losartan heart failure survival study. ELITE II. Lancet 2000; 355: 1582-87.
15. Multicenter dilitiazem post infarction trial research group. The effect of dilitiazem on mortality and reinfarction after myocardial infarction. New England Journal of Medicine 1989; 319: 385-92.
16. Packer M. Presentation of the results of the Prospective Randomized Amlodipine Survival Evaluation-2 Trial (PRAISE-2) at the American College of Cardiology Scientific Sessions, Anaheim, CA, March 15, 2000.
17. Lewis JA. Statistical issues in the regulation of medicines. Statistics in Medicine 1995; 14: 127-36.
18. Pocock SJ, Geller NL, Tsiatis AA. The analysis of multiple endpoints in clinical trials. Biometrics 1987; 43: 487-98.
19. Pfeffer MA, Stevenson LW. β-Adrenergic blockers and survival in heart failure. New England Journal of Medicine 1996; 334: 1396-7.
20. Berger VW, Rezvani Z, Makarewisz VA. Direct effect on validity of response run-in selection in clinical trials. Controlled Clinical Trials 2003; 24: 156-66.
21. Lachin JM. Introduction to sample size determinations and power analyses for clinical trials. Controlled Clinical Trials 1981; 2: 93-114.
22. Sahai H, Khurshid A. Formulae and tables for determination of sample size and power in clinical trials for testing differences in proportions for the two sample design. Statistics in Medicine 1996; 15: 1-21.
23. Donner A. Approach to sample size estimation in the design of clinical trials - a review. Statistics in Medicine 1984; 3: 199-214.
24. George SL, Desue MM. Planning the size and duration of a clinical trial studying the time to some critical event. Journal of Chronic Disease 1974; 27: 15-24.
25. Davy SJ, Graham OT. Sample size estimation for comparing two or more treatment groups in clinical trials. Statistics in Medicine 1991; 10: 3-43.
26. Moyé LA. Multiple Analyses and Clinical Trials. Springer, 2003.
27. Berger VE. On the generation and ownership of alpha in medical studies. Controlled Clinical Trials 2004; 25: 613-19.
28. Moyé LA. Alpha calculus in clinical trials: considerations and commentary for the new millenium. Statistics in Medicine 2000; 19: 767-79.
29. Moyé LA, Alpha calculus in clinical trials: considerations and commentary for the new millenium. Rejoinder Statistics in Medicine 2000; 19: 795-99.
30. Miles JL. Data torturing. New England Journal of Medicine 1993; 329: 1196-99.
31. Yusuf S, Wittes J, Probstfield J, Tyroler HA. Analysis and interpretation of treatment effects in subgroups of patients in randomized clinical trials. Journal of the American Medical Association 1991; 266: 93-8.
32. Friedman L, Furberg C, DeMets D. Fundamentals of clinical trial, third edition; Mosby 1996, 308.
33. Berger BW. Improving the information content of categorical clinical trial endpoints. Controlled Clinical Trials 2002; 23: 502-14.
34. Nester MR. An applied statistician's creed. Applied Statistics 1996; 45: 4401-410.
35. Rothman RJ. No adjustments are needed for multiple comparisons. Epidemiology 1990; 1: 43-6.
36. Fisher LD. Carvedilol and the FDA approval process: the FDA paradigm and reflections upon hypothesis testing. Controlled Clinical Trials 1999; 20: 16-39.
37. Moyé LA. Face to Face with Katrina Survivors: A First Responder's Tribute. Greensboro, North Carolina. Open Hand Publishing, 2006.