Why 'underpowered' trials are not necessarily unethical

Lancet

Volumn 350, Issue 9080, 1997, Pages 804-807

  Edwards, S J L ^a   Lilford, R J ^a   Braunholtz, David ^a   Jackson, Jennifer ^b  

^a UNIVERSITY DEPARTMENT OF MEDICINE   (United Kingdom)

^b UNIVERSITY OF LEEDS   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

BAYES THEOREM; EVIDENCE BASED MEDICINE; MEDICAL ETHICS; MEDICAL RESEARCH; METHODOLOGY; PATIENT CARE; PRIORITY JOURNAL; PROFESSIONAL STANDARD; QUALITY CONTROL; RESOURCE ALLOCATION; SHORT SURVEY; STATISTICAL ANALYSIS;

EID: 0030961105     PISSN: 01406736     EISSN: None     Source Type: Journal    
DOI: 10.1016/S0140-6736(97)02290-3     Document Type: Note

References (26)

1. Altman DG. Statistics and ethics in medical research III. How large a sample? BMJ 1980; 281: 1336-38.
2. Fayers PM, Machin D. Sample size: how many patients are necessary? Br J Cancer 1995; 72: 1-9.
3. Barnard GA. Must clinical trials be large? The interpretation of p-values and the combination of test results. Stat Med 1990; 9: 601-14.
4. De Bono M, Fawdry RDS, Lilford RJ. Size of trials for evaluation of antenatal tests of fetal well-being in high risk pregnancy. J Perinat Med 1990; 18: 77-87.
5. Lilford RJ, Braunholtz D. The statistical basis of public policy: a paradigm shift is overdue. BMJ 1996; 313: 603-07.
6. Liberati A. Meta-analysis: statistical alchemy for the 21st Century: discussion. J Clin Epidemiol 1995; 48: 81-86.
7. Thompson SG, Pocock SJ. Can meta-analysis be trusted? Lancet 1991; 338: 1127-30.
8. Sim I, Hlatky MH. Growing pains of meta-analysis. BMJ 1996; 313: 702-03.
9. Cappelleri JC, Ioannidis JP, Schmid CH, et al. Large trials vs meta-analysis of smaller trials: how do their results compare? JAMA 1996; 276: 1332-38.
10. Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbe KA. Incorporating variation of the quality of individual randomized trials into meta analysis. J Clin Epidemiol 1992; 45: 255-65.
11. Schulz KF, Chalmers I, Hayes RJ, Altman DG. Empirical evidence of bias: dimensions of methodological quality associated with estimates of treatment effects in controlled trials. JAMA 1995; 273: 408-12.
12. Antman EM, Lau J, Kupelnick B, Mosteller F, Chalmers TC. A comparison of results of meta-analysis of randomized controlled trials and recommendations of clinical experts. Treatment for myocardial infarction. JAMA 1992; 268: 240-48.
13. Fayers P, Armitage T. Towards an international register for cancer trials: the UKCCR register of UK trials. Eur J Cancer 1993; 29A: 907-12.
14. Stewart LA, Parmar MKB. Meta-analysis of the literature or of individual patient data: is there a difference? Lancet 1993; 341: 418-22.
15. Lilford RJ. Johnson N. The alpha and beta errors in randomised controlled trials. N Engl J Med 1990; 322: 780-81.
16. Schwartz D, Lellouch J. Explanatory and pragmatic attitudes in therapeutic trials. J Chronic Dis 1967; 20: 637-48.
17. Lilford RJ. Evaluating new treatments and technologies in perinatal medicine: practical problems, ethics and solutions. Int J Technol Assess Health Care 1989; 5: 459-72.
18. Freedman LS. The size of clinical trials in cancer research - what are the current needs? Br J Cancer 1989; 59: 396-400.
19. Lilford RJ, Thornton JG, Braunholtz D. Clinical trials and rare diseases: away out of the conundrum. BMJ 1995; 311: 1621-25.
20. Goodman SN, Berlin JA. The use of predicted confidence intervals when planning experiments and the misuse of power when interpreting results. Ann Intern Med 1994; 121: 200-06.
21. Freeman PR. The role of p-values in analysing trial results. Stat Med 1993; 12: 1443-52.
22. Botros S. Equipoise, consent, and the ethics of randomised controlled trials. In: Byrne P, ed. Ethics and Law in Health Care. Chichester-New York: John Wiley, 1990: 9-24.
23. Thornton H, Baum M. Ethics of clinical trials - the forbidden fruit phenomena. Breast 1996; 5: 1-4.
24. Lilford RJ, Jackson J. Equipoise and the ethics of randomisation. J R Soc Med 1995; 88: 552-59.
25. Clayton D. Ethically optimized designs. Br J Clin Pharmacol 1982; 13: 469-80.
26. Thornton JG, Lilford RJ. Preterm breech babies and randomized trials of rare conditions. Br J Obstet Gynaecol 1996; 103: 611-13.