Correspondence

Trial Registration

N Engl J Med 2007; 356:1581April 12, 2007

Article

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@mail.med.upenn.edu

5 References

1. 1

   Drazen JM, Zarin DA. Salvation by registration. N Engl J Med 2007;356:184-185
   Full Text | Web of Science | Medline

2. 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 | Web of Science | Medline

3. 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
   Full Text | Web of Science | Medline

4. 4

   Steinbrook R. Registration of clinical trials -- voluntary or mandatory? N Engl J Med 2004;351:1820-1822
   Full Text | Web of Science | Medline

5. 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

Author/Editor Response

I concur with Mr. Lott that we would be better served if data on all clinical trials were available in public databases; legislation is one way to achieve this goal. In addition to the Fair Access to Clinical Trials Act, the Kennedy–Enzi bill1 was recently introduced, with many of the same broad goals of the Fair Access to Clinical Trials Act.

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.

1 References

1. 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|.)
   

Citing Articles (2)

Citing Articles

1. 1

   EMMA R.M. COHEN, JENNIFER M. O'NEILL, MICHEL JOFFRES, ROSS E.G. UPSHUR, EDWARD MILLS. (2009) REPORTING OF INFORMED CONSENT, STANDARD OF CARE AND POST-TRIAL OBLIGATIONS IN GLOBAL RANDOMIZED INTERVENTION TRIALS: A SYSTEMATIC SURVEY OF REGISTERED TRIALS. Developing World Bioethics 9:2, 74-80
   CrossRef

2. 2

   Eduardo Montero Ruiz, Joaquín López Álvarez. (2009) Respuesta de los autores. Medicina Clínica 132:19, 761-762
   CrossRef