ClinicalTrials.gov

ClinicalTrials.gov is a web-based resource that provides information on publicly and privately supported clinical studies on a wide range of diseases and conditions. The site is maintained by the National Library of Medicine (NLM) at the National Institutes of Health (NIH).

History

ClinicalTrials.gov was launched in February 2000 to improve public access to information on clinical studies. The creation of the site was mandated by the Food and Drug Administration Modernization Act of 1997 (FDAMA). The site was initially developed to provide patients, family members, and members of the public with current information about clinical research studies.

Purpose

The primary purpose of ClinicalTrials.gov is to provide a comprehensive database of clinical trials conducted around the world. It aims to:

• Improve public access to clinical trial information.
• Enhance the transparency of clinical research.
• Facilitate the recruitment of participants for clinical studies.
• Provide a resource for researchers, healthcare professionals, and the public.

Features

ClinicalTrials.gov includes several key features:

• **Searchable Database**: Users can search for clinical studies by condition, location, phase of the trial, and other criteria.
• **Study Records**: Each study record includes information about the purpose of the study, who may participate, locations, and contact information.
• **Results Database**: The site also includes a results database where summary results of completed studies are posted.

Registration and Results Reporting

The Food and Drug Administration Amendments Act of 2007 (FDAAA) requires that certain clinical trials of drugs, biologics, and devices be registered and that results be reported on ClinicalTrials.gov. This includes:

• **Applicable Clinical Trials**: Trials of drugs and biologics that are subject to FDA regulation.
• **Results Reporting**: Summary results must be submitted within a specified time frame after the trial's completion.

Impact

ClinicalTrials.gov has had a significant impact on the field of clinical research by:

• Increasing the transparency and accountability of clinical trials.
• Providing a valuable resource for patients and healthcare providers.
• Facilitating the recruitment of participants for clinical studies.
• Enhancing the ability of researchers to identify and collaborate on clinical trials.

See Also

• Clinical trial
• National Institutes of Health
• Food and Drug Administration
• Informed consent
• Randomized controlled trial

Related Pages

• Clinical trial
• National Institutes of Health
• Food and Drug Administration
• Informed consent
• Randomized controlled trial

‎