208089 ClinicalTrials.gov: A public database of clinical research

Monday, November 9, 2009

Rebecca J. Williams, PharmD , National Library of Medicine, National Institutes of Health, Bethesda, MD
Tony Tse, PhD , National Library of Medicine, National Institutes of Health, Bethesda, MD
ClinicalTrials.gov is a public registry and results database of clinical research, containing over 69,000 active and completed interventional and observational studies conducted in 161 countries (as of February 2009). Section 801 of the Food and Drug Administration Amendments Act of 2007 (FDAAA 801) requires registration and results reporting of certain publicly and privately funded clinical trials involving drugs, biologics and devices. In addition to US Federal Law, state laws and international policies support clinical trial registration and results reporting. For example, biomedical journal editors required clinical trial registration as a condition of publication in 2005 and, following this policy change, registration in ClinicalTrials.gov increased by 73%. Clinical trial registration policies and laws are motivated by ethical and scientific principles that support increased transparency in research. In general, such principles help meet ethical obligations to research participants and ensure that researchers and health care professionals have access to existing and developing scientific evidence. This latter principle is essential for informing systematic reviews that rely on publicly available evidence to accurately assess the risks and benefits of a health intervention. Guidelines addressing conduct of such reviews (e.g., Agency for Healthcare Research and Quality (AHRQ) Methods Guide for Comparative Effectiveness Reviews) recommend using publicly accessible databases such as ClinicalTrials.gov to identify relevant published and unpublished clinical research. This presentation will discuss the policy context for clinical trial registration and results reporting as well as the practical applications of ClinicalTrials.gov, including its utility in facilitating assessment of various health risks and benefits. Emphasis will also be given to the results reporting requirements of FDAAA 801 (effective as of September 2008), the types of information required to be submitted, and how the information can be searched.

Learning Objectives:
1. Describe the policy context and legal requirements for clinical trial registration and results reporting. 2. Demonstrate how ClinicalTrials.gov can be used to identify ongoing and completed clinical studies.

Keywords: Health Information Systems, Research Ethics

Presenting author's disclosure statement:

Qualified on the content I am responsible for because: The primary topic of the abstract is ClinicalTrials.gov. I am currently the Assistant Director of ClinicalTrials.gov.
Any relevant financial relationships? No

I agree to comply with the American Public Health Association Conflict of Interest and Commercial Support Guidelines, and to disclose to the participants any off-label or experimental uses of a commercial product or service discussed in my presentation.