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Previous Volume 356:1581 April 12, 2007 Number 15 Next

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To the Editor: In their editorial, Drazen and Zarin (Jan. 11 issue)¹ express optimism about the registration of commercially sponsored clinical trials. Citing the ClinicalTrials.gov database, they report that 8% of pharmaceutical-industry registrations between January 1, 2006, and December 1, 2006, were missing information on outcome measures (down from 26% of registrations before January 1, 2006).

Unfortunately, little is known about the trial-registration policies and practices of major pharmaceutical companies.² For example, although the registration standards advocated by the International Committee of Medical Journal Editors³ are steps in the right direction, they only encourage, rather than guarantee, complete trial registration. In the absence of legal mandates for registration of all clinical trials, including phase 1 and phase 2 studies as well as trial results, no examination of today's voluntary registries can definitively indicate whether transparency in clinical research has truly improved, since unregistered trials necessarily remain unaccounted for in any analysis.

Currently, the Fair Access to Clinical Trials Act promises this legal mandate⁴ yet continues to lie dormant in U.S. congressional committees.⁵ Enactment of this legislation, should it come to pass, will be true cause for cheer.

Jason P. Lott, M.A.
University of Pennsylvania
Philadelphia, PA 19104
lottj{at}mail.med.upenn.edu

References

1. Drazen JM, Zarin DA. Salvation by registration. N Engl J Med 2007;356:184-185. [Free Full Text]
2. Lott JP, Katz KA. Pharmaceutical companies' policies and practices regarding prospective registration of dermatology-related clinical trials. Br J Dermatol 2006;155:635-638. [CrossRef][ISI][Medline]
3. De Angelis C, Drazen JM, Frizelle FA, et al. Clinical trial registration: a statement from the International Committee of Medical Journal Editors. N Engl J Med 2004;351:1250-1251. [Free Full Text]
4. Steinbrook R. Registration of clinical trials -- voluntary or mandatory? N Engl J Med 2004;351:1820-1822. [Free Full Text]
5. Henderson JK, Cassady Q. Drug deals 2006: cutting edge legal and regulatory issues in the pharmaceutical industry. Ann Health Law 2006;15:107-149. [Medline]

In the absence of legislation, investigators must be vigilant. It was not my goal to suggest that Dr. Motzer should have personally registered his clinical trial on the treatment of renal-cell carcinoma. Instead, I urge all investigators participating in a clinical trial to check the registration to be sure it is fair, accurate, and fully informative.

Jeffrey M. Drazen, M.D.

References

1. Kennedy-Enzi bill, S.484. (Accessed March 22, 2007, at http://thomas.loc.gov/cgi-bin/bdquery/D?d110:464:./list/bss/d110SN.lst::|TOM:/bss/110search.html|.)

PDF PDA Full Text Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear Related Article by Drazen, J. M. PubMed Citation

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