Clinical Trial Registration
http://www.100md.com
《新英格兰医药杂志》
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@mail.nih.gov
References
Grass G. Clinical trial registration. N Engl J Med 2005;352:198-199.
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.)
Deborah A. Zarin, M.D.
ClinicalTrials.gov
Bethesda, MD 20894
dzarin@mail.nih.gov
References
Grass G. Clinical trial registration. N Engl J Med 2005;352:198-199.
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.)