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Previous Volume 352:1611 April 14, 2005 Number 15 Next

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To the Editor: In reply to the letter from Grass (Jan. 13 issue),¹ we would like to clarify that www.clinicaltrials.gov was expanded in October 2004 to allow for the registration of any clinical trial that has been approved by a human subjects review board (or the equivalent) and that conforms to the regulations of the appropriate national or international health authority. We encourage investigators and sponsors of clinical trials that meet these criteria to register their trials at this Web site. In addition, current U.S. law mandates the registration of trials that are designed to evaluate the efficacy of drugs for the treatment of serious or life-threatening diseases and that are intended to support a new drug application to the Food and Drug Administration.² For more information about registration of clinical trials, see http://prsinfo.clinicaltrials.gov.

Deborah A. Zarin, M.D.
ClinicalTrials.gov
Bethesda, MD 20894
dzarin{at}mail.nih.gov

References

1. Grass G. Clinical trial registration. N Engl J Med 2005;352:198-199. [Free Full Text]
2. Food and Drug Administration. Guidance for industry: information program on clinical trials for serious or life-threatening diseases and conditions. Rockville, Md.: Department of Health and Human Services, March 2002. (Accessed March 16, 2005, at http://www.fda.gov/cder/guidance/4856fnl.htm.)

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Related Letters:

Clinical Trial Registration
Grass G., Reveiz L., Cardona A. F., Ospina E. G., Kulvichit K., Kulwichit W., Lumbiganon P.
Extract | Full Text | PDF  
N Engl J Med 2005; 352:198-199, Jan 13, 2005. Correspondence

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