Institutional review boards should require clinical trial registration

Archives of Internal Medicine

Volumn 167, Issue 15, 2007, Pages 1576-1580

  Levin, Leonard A ^a,b   Palmer, Julie Gage ^c  

^a UNIVERSITY OF WISCONSIN SCHOOL OF MEDICINE AND PUBLIC HEALTH   (United States)

^b UNIVERSITÉ DE MONTRÉAL   (Canada)

^c UNIVERSITY OF CHICAGO LAW SCHOOL   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

CLINICAL TRIAL; HEALTH CARE ORGANIZATION; INFORMED CONSENT; LEGAL ASPECT; MEDICAL ETHICS; PRIORITY JOURNAL; REGISTER; REVIEW; RISK BENEFIT ANALYSIS;

CLINICAL TRIALS; ETHICS COMMITTEES, RESEARCH; HUMANS; INFORMED CONSENT; REGISTRIES;

EID: 34548012195     PISSN: 00039926     EISSN: 15383679     Source Type: Journal    
DOI: 10.1001/archinte.167.15.1576     Document Type: Review

References (27)

1. World Health Organization International Clinical Trials Registry Platform (ICTRP). http://www.who .int/ictrp/background/en. World Health Organization Web site. Accessed March 17, 2007.
2. American Medical Association Council on Scientific Affairs. Featured Report: Influence of Funding Source on Outcome, Validity, and Reliability of Pharmaceutical Research (A-04) Full Text. Chicago, IL: American Medical Association; 2004.
3. The Ottawa Group. The Ottawa statement, part one: principles for international registration of protocol information and results from human trials of health-related interventions. http://ottawagroup.ohri.ca/statement.html. Accessed March 17, 2007.
4. The Ottawa Group. Draft - The Ottawa statement, part two: principles of operationalisation for international trial registration. http://ottawagroup. ohri.ca/statement2.html. Accessed March 17, 2007.
5. Aronson D. Biotechnology Industry Organization comments on the WHO International Clinical Trials Registry Platform. http://www.who.int/ictrp/ BiotechnologyIndustryOrganization_DebraAronson. pdf. Accessed March 17, 2007.
6. The European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japan Pharmaceutical Manufacturers (JPMA), and the Pharmaceutical Research and Manufacturers of America (PhRMA). Joint position on the disclosure of clinical trial information via clinical trial registries and databases. http://www.ifpma.org/documents/NR2204/joint position_clinical trials .pdf. Accessed May 28, 2007.
7. Committee on Clinical Trial Registries. Developing a National Registry of Pharmacologic and Biologic Clinical Trials: Workshop Report. Washington, DC: National Academies Press; 2006.
8. DeAngelis CD, Drazen JM, Frizelle FA, et al. Is this clinical trial fully registered? a statement from the International Committee of Medical Journal Editors. JAMA. 2005;293(23):2927-2929.
9. Avorn J. Dangerous deception - hiding the evidence of adverse drug effects. N Engl J Med. 2006; 355(21):2169-2171.
10. DeAngelis CD, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. JAMA. 2004;292(11):1363-1364.
11. International Committee of Medical Journal Editors. Journals that have requested inclusion on the list of publications that follow the ICMJE's Uniform Requirements for Manuscripts Submitted to Biomedical Journals. http://www.icmje.org/jrnlist .html. Accessed April 4, 2006.
12. The Nuremberg Code: Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10. Vol 2. Washington, DC: US Government Printing Office; 1949:181-182.
13. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Belmont Report: ethical principles and guidelines for the protection of human subjects of research. National Institutes of Health Web site. http://ohsr.od.nih.gov/guidelines/belmont.html. 1979. Accessed July 5, 2007.
14. Is GSK guilty of fraud? Lancet. 2004;363(9425):1919.
15. Frank RN. Potential new medical therapies for diabetic retinopathy: protein kinase C inhibitors. Am J Ophthalmol. 2002;133(5):693-698.
16. Daugherty C, Ratain MJ, Grochowski E, et al. Perceptions of cancer patients and their physicians involved in phase I trials. J Clin Oncol. 1995;13(5):1062-1072.
17. Protection of Human Subjects, 45 USC §46.116 (2005).
18. Protection of Human Subjects, 45 USC §46.111 (2005).
19. Grimes v Kennedy Krieger Institute Inc, 366 Md 29, 131 (2001).
20. Abney et al v Amgen Inc, 443 F3d 540 (6th Cir 2006).
21. Proceedings of the Fordham University Summit on Bio-Pharmaceuticals in the 21st Century: responsibility, sustainability, and public trust. 2005.http: //www.clinicaltrialsethics.org/content/FordhamRegistriesDatabaseWhitePaper_ Sept_2_2005.pdf. Accessed March 18, 2007.
22. Rennie D. Trial registration: a great idea switches from ignored to irresistible. JAMA. 2004;292(11):1359-1362.
23. Guidance documents. http://www.fda.gov/cder/guidance/index.htm. Food and Drug Administration Center for Drug Evaluation and Research Web site. Accessed March 17, 2007.
24. Zarin D. Clinicaltrials.gov comments on the WHO Clinical Trial Registry Platform. http://www.who.int/ictrp/ClinicalTrials_gov-Deborah_Zerin.pdf. Accessed March 17, 2007.
25. Lemmens T, Bouchard R. Comments on the legal, regulatory and ethical aspects of the WHO Clinical Trial Registry Platform. http://www.who.int/ictrp/ 011_Lemmens_Bouchard_5April06.pdf. Accessed March 17, 2007.
26. Laine C, Horton R, DeAngelis CD, et al. Clinical trial registration: looking back and moving ahead. JAMA . 2007;298(1):93-94.
27. Wood AJ, Darbyshire J. Injury to research volunteers-the clinical - research nightmare. N Engl J Med. 2006;354(18):1869-1871.