Trial Registration for Public Trust: Making the Case for Medical Devices
- Ida Sim MD, PhD
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Recently, several pharmaceutical companies have been shown to have withheld negative clinical trial results from the public. These incidents have resulted in a concerted global effort to register all trials at inception, so that all subsequent results can be tracked regardless of whether they are positive or negative. These trial registration policies have been driven in large part by concern about the pharmaceutical sector. The medical device industry is much smaller, and different from the pharmaceutical industry in some fundamental ways. This paper examines the issues surrounding registration of device trials and argues that these differences with pharmaceutical should not exempt device trials from registration.
- People of the State of New York vs GlaxoSmithKline. Filed June 2, 2004.
- Curfman GD, Morrissey S, Drazen JM. Expression of concern: Bombardier et al., Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. N Engl J Med. 2000;343:1520–8. N Engl J Med 2005;353(26):2813–4.
- DeAngelis, CD, Drazen, JM, Frizelle, FA (2004) Clinical trial registration: a statement from the international committee of medical journal editors. JAMA 292: pp. 1363-1364 CrossRef
- AdvaMed Response to the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) Request for Comments on Delayed Disclosure. March 31, 2006.
- Popp, RL, Lorell, BH, Stone, GW, Laskey, W, Smith, JJ, Kaplan, AV (2006) An outline for public registration of clinical trials evaluating medical devices. J Am Coll Cardiol 47: pp. 1518-1521 CrossRef
- Profitless prosperity. The Economist, April 20, 2006.
- Cutler, D (2007) The demise of the blockbuster?. N Engl J Med 356: pp. 1292-1293 CrossRef
- Maisel, WH (2004) Medical device regulation: an introduction for the practicing physician. Ann Intern Med 140: pp. 296-302
- Califf, RM (2006) Evaluation of diagnostic imaging technologies and therapeutics devices: better information for better decisions: proceedings of a multidisciplinary workshop. Am Heart J 152: pp. 50-58 CrossRef
- Rennie, D (2004) Trial registration: a great idea switches from ignored to irresistible. JAMA 292: pp. 1359-1362 CrossRef
- Dickersin, K, Rennie, D (2003) Registering clinical trials. JAMA 290: pp. 516-523 CrossRef
- Krleza-Jeric, K, Chan, AW, Dickersin, K, Sim, I, Grimshaw, J, Gluud, C (2005) Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1). BMJ 330: pp. 956-958 CrossRef
- World Health Organization. International Clinical Trials Registry Platform. Available at: http://www.who.int/ictrp/. Accessed March 29, 2007.
- World Health Organization. International Clinical Trials Registry Platform Glossary. Available at: http://www.who.int/ictrp/glossary/en/index.html. Accessed March 29, 2007.
- IFPMA Comments to ICTRP Consultation on Delayed Disclosure. January 25, 2006. Available at: http://www.who.int/ictrp/3005_IFPMA_25Jan06.pdf. Accessed March 29, 2007.
- Sim, I, Chan, AW, Gülmezoglu, AM, Evans, T, Pang, T (2006) Clinical trial registration: transparency is the watchword. Lancet 367: pp. 1631-1633 CrossRef
- Laine, C, Horton, R, Deangelis, CD (2006) Clinical trial registration: Looking back and moving ahead. N Engl J Med. 356: pp. 2734-2736 CrossRef
- Lassman S. RE: PhRMA comments on international clinical trials registry platform (ICTRP) disclosure timing. January 25, 2006. Available at: http://www.who.int/ictrp/3010_PhRMA_25Jan06.pdf. Accessed March 29, 2007.
- World Medical Association. Declaration of Helsinki. 9 Oct 2004. Available at: http://www.wma.net/e/policy/b3.htm. Accessed March 29, 2007.
- Nuremberg Code. Trials of war criminals before the Nuremberg military tribunals under control council law No. 10. In: U.S. Government Printing Office; Washington, D.C; 1949:181–2.
- Palmisano S. The information puzzle. Newsweek, December 2, 2005.
- Enhancing Drug Safety and Innovation Act, H.R. 1561, 110th Congress, 1st Session (2007).
- Enhancing Drug Safety and Innovation Act, S. 484, 110th Congress, 1st Session (2007).
- Derbis J, Toigo T, Woods J, Evelyn B, Banks D. FDAMA Section 113: Information program on clinical trials for serious or life threatening diseases: update on implementation. In: 9th Annual FDA Science Forum. Washington, D.C; 2003.
- Zarin, DA, Tse, T, Ide, NC (2005) Trial registration at ClinicalTrials.gov between May and October 2005. N Engl J Med 353: pp. 2779-2787 CrossRef
- Patsopoulos, NA, Ioannidis, JP, Analatos, AA (2006) Origin and funding of the most frequently cited papers in medicine: database analysis. BMJ 332: pp. 1061-1064 CrossRef
- Trial Registration for Public Trust: Making the Case for Medical Devices
- Open Access
- Available under Open Access This content is freely available online to anyone, anywhere at any time.
Journal of General Internal Medicine
Volume 23, Issue 1 Supplement, pp 64-68
- Cover Date
- Print ISSN
- Online ISSN
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- medical device industry
- trial registration policies
- public trust
- Industry Sectors
- Ida Sim MD, PhD (1) (2)
- Author Affiliations
- 1. Division of General Internal Medicine, Department of Medicine, University of California, San Francisco, 400 Parnassus Ave., Rm. A-405, San Francisco, CA, 94143-0320, USA
- 2. Center for Clinical and Translational Informatics, University of California, San Francisco, San Francisco, CA, 94143-0320, USA