Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2000 May-Jun;7(3):313-23.
doi: 10.1136/jamia.2000.0070313.

Design and implementation of a national clinical trials registry

A T McCray  1 , N C Ide
Affiliations

Design and implementation of a national clinical trials registry

A T McCray et al. J Am Med Inform Assoc. 2000 May-Jun.

Abstract

The authors have developed a Web-based system that provides summary information about clinical trials being conducted throughout the United States. The first version of the system, publicly available in February 2000, contains more than 4,000 records representing primarily trials sponsored by the National Institutes of Health. The impetus for this system has come from the Food and Drug Administration (FDA) Modernization Act of 1997, which mandated a registry of both federally and privately funded clinical trials "of experimental treatments for serious or life-threatening diseases or conditions." The system design and implementation have been guided by several principles. First, all stages of system development were guided by the needs of the primary intended audience, patients and other members of the public. Second, broad agreement on a common set of data elements was obtained. Third, the system was designed in a modular and extensible way, and search methods that take extensive advantage of the National Library of Medicine's Unified Medical Language System (UMLS) were developed. Finally, since this will be a long-term effort involving many individuals and organizations, the project is being implemented in several phases.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Portion of document type definition (DTD) in current system.
Figure 2
Figure 2
System design.
Figure 3
Figure 3
Data preparation subsystem.
Figure 4
Figure 4
Portion of the clinical trials home page.
Figure 5
Figure 5
Results of a simple search.
Figure 6
Figure 6
Portion of a clinical trials record.
Figure 7
Figure 7
Focused search page.
See this image and copyright information in PMC

References

    1. FDA Modernization Act of 1997, Public Law 105-115, 105th Congress. Section 113, Information Program on Clinical Trials for Serious or Life-threatening Diseases. Food and Drug Administration Web site. Available at: http://www.fda.gov/cder/guidance/105-115.htm . Accessed Jan 11, 2000.
    1. Chalmers I. The Cochrane Collaboration: Preparing, maintaining, and disseminating systematic reviews of the effects of health care. Ann NY Acad Sci. 1993;703: 156-63. - PubMed
    1. Dickersin K. Report from the panel on the case for registers of clinical trials at the eighth annual meeting of the society for clinical trials. Control Clin Trials. 1988;9: 76-81. - PubMed
    1. Meinert CL. Toward prospective registration of clinical trials. Control Clin Trials. 1988;9: 1-5. - PubMed
    1. Sim I. A trial bank model for the publication of clinical trials. Proc AMIA Annu Fall Symp. 1995: 863-7. - PMC - PubMed

MeSH terms