Catherine D. De Angelis, MD, MPH; Jeffrey M. Drazen, MD; Frank A. Frizelle, MB, ChB, MMedSc, FRACS; Charlotte Haug, MD, PhD, MSc; John Hoey, MD; Richard Horton, FRCP; Sheldon Kotzin, MLS; Christine Laine, MD, MPH; Ana Marusic, MD, PhD; A. John P.M. Overbeke, MD, PhD; Torben V. Schroeder, MD, DMSc; Harold C. Sox, MD; Martin B. Van Der Weyden, MD
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Table. Minimal Registration Data Set
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Nikheel S Kolatkar
Brigham and Women's Hospital
July 22, 2005
Medical Meetings: Science or Sales?
DeAngelis et. al. reviewed the International Committee of Medical Journal Editors (ICMJE) joint policy advocating clinical trial registration (1). The policy, in addition to disclosure requirements regarding author contribution and conflict of interest, exemplify actions scientific journals are taking to promote integrity and transparency. Like the ICMJE, medical societies should establish guidelines covering presentations at their scientific meetings. As summarized by Dr. DeAngelis during the recent 87th Annual Meeting of the Endocrine Society (ENDO), the distinction between science and sales at medical meetings is becoming blurred (2). At ENDO (not including ancillary continuing medical education programs), 13% (1/8) of Plenary Sessions, 25% (17/69) of Scientific Symposia, 25% (19/72) of Meet-The-Professor sessions, were labeled as "supported" by a company (3). In each case, the sponsor sold a product, service, or diagnostic referenced during the presentation. Support of individual scientific presentations is analogous to sponsorship of individual journal articles and such presentations should be marked "advertisement" under Title 18, Section 1734 of the United States Code (4).
1. Is This Clinical Trial Fully Registered? A Statement From the International Committee of Medical Journal Editors. DeAngelis CD, Drazen JM, Frizelle FA, Haug C, et. al. Ann Int Med 2005;143(2):146-148.
2. Issues in Publishing Clinical Trials "“ An Editor's Perspective. Oral presentation at the 87th Annual Meeting of the Endocrine Society, San Diego, California, June 4, 2005.
3. The 87th Annual Meeting of the Endocrine Society Final Program. The Endocrine Society. 2005.
4. http://www.access.gpo.gov/uscode/title18/title18.html. Accessed on July 22, 2005.
Advocate Lutheran General Hospital
July 23, 2005
Institutunal Review Boards as Surrogate Registries
Clinical trial registries are the future for clinical research. However, one must also address concerns regarding those current and past clinical trials which may carry the risks of data derived conclusions or have other uncertainties regarding the intended primary outcome. Perhaps Institutional Review Boards now ought to publish all of their archives. In my experience, IRB filings are typically quite thorough. While these documents will certainly not contain all 20 elements of the proposed Minimum Data Registration Set, they will potentially fill in some of the gaps in our understanding of certain research and also call our attention to trials which were most likely undertaken though never published.
De Angelis CD, Drazen JM, Frizelle FA, Haug C, Hoey J, Horton R, et al. Is This Clinical Trial Fully Registered?: A Statement from the International Committee of Medical Journal Editors*. Ann Intern Med. 2005;143:146-148. doi: 10.7326/0003-4819-143-2-200507190-00016
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Published: Ann Intern Med. 2005;143(2):146-148.
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