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April 2013 Technical Report to the LHNCBC Board of Scientific Counselors

The National Library of Medicine (NLM) launched in February 2000 in response to Section 113 of the Food and Drug Administration (FDA) Modernization Act of 1997 (FDAMA 113). Since then, the database has been expanded to accommodate certain scientific goals as well as key international registration policies including the International Committee of Medical Journal Editors (ICMJE) Obligation to Register Clinical Trials, which requires prospective registration in an acceptable public database as a condition of publication. Most recently, the registry requirements were expanded, and a results database was developed and added, in response to Section 801 of the FDA Amendments Act of 2007 (FDAAA 801).

Prospective registration and systematic results reporting provide for public access to key information about clinical research in humans. Public disclosure (1) allows people to find information on participation in research, (2) meets ethical and scientific obligations to ensure that research contributes to the medical evidence base, (3) promotes scientific integrity, and (4) provides summary information for exploring ethical, legal, and scientific aspects of the clinical research enterprise.

The Web site ( receives over 95 million page views and approximately 900,000 unique visitors per month. Data are submitted to through a Web-based Protocol Registration System (PRS) by over 12,000 sponsors including the U.S. federal government, pharmaceutical and device companies, academic, and international organizations. As of early March 2013, listed nearly 142,000 interventional and observational studies with locations in all 50 states and in 182 countries. Approximately one-third of the studies are (or will be) open to recruitment, and the remaining two-thirds are closed to recruitment or completed. The number of registered studies has increased nearly 10-fold since May 2005, the last review by the Board of Scientific Counselors (BoSC) [see Table 1]. Since the launch of the results database in September 2008, over 8,320 of the registered studies include summary results tables.

This report summarizes the changes and updates to the and Related Projects program since the May 2005 BoSC report. In particular, we focus in more detail on three key areas of development during the past 8 years:

  1. Developing and implementing a de novo “basic” results database [see Key Accomplishment 2 under section 4. Methods and Procedures]]
  2. Developing and implementing quality assurance (QA) criteria, a review process, and a system within the PRS to evaluate results submissions prior to public posting on [See Key Accomplishment 3 under section 4. Methods and Procedures]
  3. Using aggregate data from the registry and results database to assess the overall state of the clinical research enterprise [see Utilization under section 5. Evaluation Plan]
Zarin DA, Williams RJ, Bergeris AM, Dobbins H, Ide NC, Loane RF, Robbins A, Tse T. and Related Projects: Improving Access to Information about Clinical Trials April 2013 Technical Report to the LHNCBC Board of Scientific Counselors