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U.S. Department of Health and Human Services

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1,000 Industry-sponsored Studies Milestone

 

FDA News

 

FOR IMMEDIATE RELEASE
P03-86
October 27, 2003

 

Media Inquiries: 301-827-6242Consumer Inquiries: 888-INFO-FDA


A Milestone for ClinicalTrials.gov Web Site

 

ClinicalTrials.gov, an Internet data bank providing useful information on studies of drugs and biological products regulated by the Food and Drug Administration, has reached a significant new landmark by posting its 1,000th study sponsored by the private sector. The clinical trials web site http://ClinicalTrials.gov, the world’s largest source of clinical trial information, now lists a total of approximately 8,600 federally- and privately-sponsored trials throughout the United States and abroad.

“The listing of 1,000 industry-sponsored studies is a milestone in our efforts to make critically important public health information available to patients," said Mark B. McClellan, M.D., Ph.D., Commissioner of Food and Drugs. "We will continue to work with the private sector to help improve access to promising new treatments.”

ClinicalTrials.gov was launched in February 2000 by the National Library of Medicine, a component of the National Institutes of Health (NIH), in consultation with FDA and other agencies. The data bank is authorized by the FDA Modernization Act, which requires drug companies and other organizations to make public their studies of experimental medications for serious or life-threatening diseases. After publishing the final guidance on listing of studies in ClinicalTrials.gov, FDA notified more than 2,000 private sector drug sponsors of their legal obligation to promote data submission through a Web-based protocol-registration system http://PRSinfo.ClinicalTrials.gov/. This system provides a straightforward and efficient way for sponsors to submit the information about their studies electronically.

Further information about clinical trials of medical products is available on FDA’s web site at http://www.fda.gov.

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