Skip to main navigation menu Skip to main content Skip to site footer

Reflections

Vol. 6 No. 1 (2001)

The Placebo Standard in Regulatory Market Approval: Why the Declaration of Helsinki Has Been Ignored for 35 years

  • Patrick James Villeneuve, B.Sc., B.A.Sc.
DOI
https://doi.org/10.26443/mjm.v6i1.417
Submitted
October 29, 2020
Published
2020-12-01

Abstract

N/A

References

  1. World Medical Association Recommendations Guiding Physicians in Biomedical Research Involving Human Subjects. World Medical Association 48th General Assembly; 1996.
  2. ICH Harmonised tripartite guideline: General considerations for clinical trials (E8). Step 4; July 17, 1997
  3. Freedman B. Equipoise and the ethics of clinical research. New England Journal of Medicine 1987; 317: 141-145.
  4. Aspinall RL, Goodman NW. Denial of effective treatment and poor quality of clinical information in placebo controlled trials of ondansetron for postoperative nausea and vomiting: a review of published trials. BMJ 1995; 331: 844-846.
  5. Rothman KJ, Michels KB. The continuing unethical use of placebo controls. New England Journal of Medicine 1994; 331: 394-398.
  6. Brody BA. When are placebo-controlled trials no longer appropriate? Controlled Clinical Trials 1997; 18: 602-612.
  7. ICH Harmonised tripartite guideline: choice of control group and related issues in clinical trials (E10) Step 4; July 20, 2000.
  8. Temple R. Appears in: The use of placebos in clinical trials and the ethics of the use of placebos. US Department Of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Committee for Advanced Scientific Education Seminar Series; 1999.
  9. GUSTO Investigators. An international randomized trial comparing four thrombolytic strategies for acute myocardial infarction. New England Journal of Medicine 1993; 329: 673-682.
  10. Mascioli SR, Grimm RH Jr, Neaton JD, et al. Characteristics of participants at baseline in the treatment of mild hypertension study (TOHMS). American Journal of Cardiology 1990; 66: 32-50.
  11. Henry D, Hill S. Comparing treatments. BMJ 1995; 310: 1279.
  12. Collins R. Appears in: Basic statistical considerations for the evaluation of active controlled clinical trials. 82nd meeting of the cardiovascular and renal drugs committee. US Department
  13. of Health and Human Services, Public Health Service, Food and Drug Administration; 1997.
  14. Tramer MR, Reynolds DJ, Moore RA, McQuay HJ. When placebo controlled trials are essential and equivalence trials are inadequate. BMJ 1998, 317: 875-880.

Downloads

Download data is not yet available.