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U.S. Department of Health and Human Services

For Consumers

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Food and Drug Administration Modernization Act (FDAMA) Section 113 and ClinicalTrials.gov

Information about clinical trials is available through the Resources link on the ClinicalTrials.gov Web site at http://clinicaltrials.gov/ct/info/resources.

FDA and the National Library of Medicine (NLM) helped more than 4,551,895 consumers learn about clinical trials and the ClinicalTrials.gov website, by broadcasting two FDA sponsored 60-second consumer health features and a series of interviews with Commissioner Mark McClellan. Dr. McClellan discussed medical research, human research subject safety, and clinical trials.gov. ClinicalTrials.gov is a Web-based database of medical research studies developed by the National Library of Medicine, in collaboration with colleagues at the National Institutes of Health (NIH) and the FDA.

Dr. Benjamin S. Carson, Director of the Division of Pediatric Neurosurgery of Johns Hopkins University recorded one of the 60-second audio news releases about clinical trials and ClinicalTrials.gov. It aired 762 times over 399 radio stations across the United States, reaching approximately 2,291,095 people.

To reach Spanish speaking consumers, Dr. Elmer Huerta, Director, Cancer Preventorium, Washington Hospital Center recorded the same news release. It was broadcast 305 times on 69 Spanish language radio stations, reaching some 2,260,800 listeners around the country.

In January and February 2004, local and national radio networks and stations conducted a number of 5 - 8 minute interviews with then FDA Commissioner Mark McClellan about topics ranging from "what a clinical trial is" to who should consider participating in medical research studies, and FDA's role in approving new drugs and treatments. The broadcasts reached more than 4,000,000 listeners around the country.

A representational transcript is available.