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FDA Issues Guidance on Information Submission
ROCKVILLE, MD-The first public version of the Clinical Trials Data Bank can now be accessed at http://clinicaltrials.gov. The Modernization Act enacted in November 1997 directs the Secretary of Health and Human Services, acting through the Director, National Institutes of Health (NIH), to establish and maintain a data bank of information on clinical trials of new treatments for serious or life-threatening diseases and conditions. The data bank includes information about both federal and privately funded clinical trials, a description of the purpose of the experimental drug, patient eligibility criteria, location of the trial site, and a point of contact for individuals who want to participate. Section 113 of the Modernization Act stipulates the data bank information be in a format easily understood by the public.
Though this first phase of the data bank includes mostly NIH-sponsored trials, later in the year data from other Federal agencies and private companies should be included. In conjunction with the release of the database, the Food and Drug Administration (FDA) created a guidance document for sponsors of investigational new drug applications to submit information to the data bank. The guidance only proposes the statutory requirements for submission of information, not an actual implementation plan addressing procedural issues. The guidelines for submission include data, time, and certification requirements. There are guidelines for providing additional information.