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National Institutes of Health Launches ClinicalTrials.gov Results Database

The National Institutes of Health (NIH) today announced an expanded ClinicalTrials.gov database. The database will accept basic results information, in addition to trial registrations. Due to growing public interest and a desire for improved access to clinical trial information and greater transparency in clinical research, Congress enacted Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85, section 801). In response to this new legislative mandate, those responsible for conducting clinical trials will submit data after the trial is completed. The enhanced database will provide summary results statistics for a broad range of trials of drugs, medical devices and biological products that have been approved by the Food and Drug Administration. Patient-identifiable information will not be included.

"Providing scientists, physicians, and the public with results information could go a long way toward improving safety," said Director Elias Zerhouni, M.D.

Clinical trials are research studies that test how well new medical approaches work in people. Each study answers specific scientific questions and tries to find better ways to prevent, screen for, diagnose, or treat a disease. Since 2000, ClinicalTrials.gov, the largest single registry of clinical trials, has provided patients, families and members of the public with easy access to information about a trial's purpose, who may participate, locations, and phone numbers for more details. This Web site currently has information on nearly 62,000 ongoing and completed trials sponsored by the U.S. Federal government, pharmaceutical industry, academic, and international organizations with locations in all 50 States and in 157 countries.

"In time, the results database will be a powerful tool for researchers and health care consumers alike, and will have untold benefits for the public health too." said Donald A.B. Lindberg, M.D., Director of the NIH's National Library of Medicine which developed and administers the new results database.

Results information will be integrated into the clinical trial records that can be reached at http://clinicaltrials.gov/, and through its consumer health information service, MedlinePlus, at http://medlineplus.gov. MedlinePlus has extensive links to information about 750 diseases and health conditions, much of it from the NIH Institutes and Centers.

The National Institutes of Health (NIH) -- The Nation's Medical Research Agency -- includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

Located in Bethesda, Md., the National Library of Medicine is the world's largest library of the health sciences. For more information, visit the Web site at http://www.nlm.nih.gov.

*Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA, Public Law 110-85, section 801) enacted on September 27, 2007, expanded the scope of trials and information required to be submitted to Clinical Trials.gov and required the submission of results data. This system builds on the existing ClinicalTrials.gov Protocol Registration System and allows sponsors and principal investigators to clinical trials to submit "basic results" summary data necessary to satisfy statutory requirements. Submission will be publicly posted on ClinicalTrials.gov (http://clinicaltrials.gov/)

For more information contact:
Kathleen Cravedi
301-496-6308
cravedik@nlm.nih.gov

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