Correspondence
Clinical Trial Registration
N Engl J Med 2005; 352:1611April 14, 2005
- Article
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.
2 ReferencesDeborah A. Zarin, M.D.
ClinicalTrials.gov, Bethesda, MD 20894
dzarin@mail.nih. gov 1
Grass G . Clinical trial registration. N Engl J Med 2005;352:198-199
Full Text | Web of Science | Medline2
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.)
