Risk, Helsinki 2000 and the use of placebo in medical research

Clinical Medicine

Volumn 3, Issue 5, 2003, Pages 435-439

  Saunders, John ^a,b   Wainwright, Paul ^a  

^a SWANSEA UNIVERSITY   (United Kingdom)

^b NEVILL HALL HOSPITAL   (United Kingdom)

Author keywords

Declaration of Helsinki; Equivalence trials; Placebo; Research ethics

Indexed keywords

PLACEBO;

ACQUIRED IMMUNE DEFICIENCY SYNDROME; ALTRUISM; CLINICAL PRACTICE; HEALTH CARE; MEDICAL ETHICS; MEDICAL RESEARCH; REVIEW; RISK ASSESSMENT;

EID: 0142229372     PISSN: 14702118     EISSN: None     Source Type: Journal    
DOI: 10.7861/clinmedicine.3-5-435     Document Type: Review

References (19)

1. Miller FG, Rosenstein DL. The therapeutic orientation to clinical trials. N Engl J Med 2003;348:1383-6.
2. Levine RJ. The need to revise the Declaration of Helsinki. N Engl J Med 1999;341:531-4.
3. Brennan TA. Proposed revisions to the Declaration of Helsinki - will they weaken the ethical principles underlying human research? N Engl J Med 1999;341:527-31.
4. European Commission. The rules governing medicaments in the European Community. Brussels: EC, 1978 (Council Directive 75/318/EEC).
5. European Agency for the Evaluation of Medicinal Products/Committee for Proprietary Medicinal Products. Position statement on the use of placebo in clinical trials, with regard to the revised Declaration of Helsinki, 28 June 2001. www.emea.en.int/pdfs/human/press/pr/202001en.pdf
6. Food and Drug Administration. International Conference on Harmonisation: choice of control group in clinical trials. Fed Regist 1999;64:51767.
7. Bland M. WMA should not retreat on use of placebos. BMJ 2002;324:240.
8. Huston P, Peterson R. Withholding proven treatment in clinical research. N Engl J Med 2001;345:912-4.
9. Emanuel EJ, Miller FG. The ethics of placebo-controlled trials - a middle ground. N Engl J Med 2001;345:915-9.
10. Tramer MR, Reynolds DJ, Moore A, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. Review. BMJ 1998;317:875-80.
11. Leon AC. Can placebo controls reduce the number of nonresponders in clinical trials? A power-analytic perspective. Clin Ther 2001;23:596-603.
12. Garattini S, Bertele V, Li Bassi L. How can research ethics committees protect patients better? BMJ 2003;326:1199-201.
13. Collier J. Confusion over use of placebos in clinical trials. BMJ 1995;311:821-2.
14. Lewis JA, Jonsson B, Kreutz G, Sampaio C, van Zwieten-Boot B. Placebo-controlled trials and the Declaration of Helsinki. Lancet 2002;359:1337-40.
15. Royal College of Physicians. Guidelines on the practice of ethics committees in medical research involving human subjects. London: RCP, 1996.
16. International ethical guidelines for biomedical research involving human subjects. Geneva: Council of International Organisations of Medical Sciences, 2002.
17. Steering Committee on Bioethics. Draft additional protocol to the Convention on Human Rights and Biomedicine on Biomedical Research. Strasbourg: Council of Europe, 2003.
18. How consumers can and should improve clinical trials. Lancet 2001;357:1721.
19. Koops L, Lindley RI. Thrombolysis for acute ischaemic stroke: consumer involvement in design of new randomised controlled trial. BMJ 2002;325:415.