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Clinical Trials

clinical trials

Clinical Trials

http://clinicaltrials.gov

Provides a search engine to find clinical trials in your area.

ClinicalTrials.gov is a Web-based resource that provides patients, their family members, health care professionals, researchers, and the public with easy access to information on publicly and privately supported clinical studies on a wide range of diseases and conditions.  The Web site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

ClinicalTrials.gov was created as a result of the Food and Drug Administration Modernization Act of 1997 (FDAMA).  FDAMA required the U.S. Department of Health and Human Services, through NIH, to establish a registry of clinical trials information for both federally and privately funded trials conducted under investigational new drug applications (IND) to test the effectiveness of experimental drugs for serious or life-threatening diseases or conditions.  NIH and the Food and Drug Administration (FDA) worked together to develop the site, which was made available to the public in February 2000.

ClinicalTrials.gov includes information about medical studies in human volunteers.  Most of the records in ClinicalTrials.gov describe clinical trials (also called interventional studies).

A clinical trial is a research study in which human volunteers are assigned to interventions (for example, a medical product, behavior, or procedure) based on a protocol (or plan) and are then evaluated for effects on biomedical or health outcomes.

ClinicalTrials.gov also includes records describing observational studies and programs providing access to investigational drugs outside of clinical trials (expanded access).  Studies listed in the database are conducted in all 50 States and in 185 countries.  ClinicalTrials.gov does not contain all clinical studies conducted in the United States because not all studies are required by law to be registered.  However, the number of studies registered each year has increased over time as more policies and laws requiring registration have been enacted and as more sponsors and investigators voluntarily register their studies.

 

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