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Creating an NIH Clinical Trials Registry: A User Friendly Approach to Health Care: The National Institutes of Health (NIH)

Date: June 8, 1994
Source: Journal of the American Medical Association (JAMA)

Creating an NIH Clinical Trials Registry: A User Friendly Approach to Health Care: The National Institutes of Health (NIH) is surveying its existing information networks with the aim of assembling an easily accessed database of NIH- funded clinical trials--ongoing, completed but unpublished, and published.

Building on the impetus of a Congressional mandate to create a clinical trials registry for women's health, NIH's Office of Medical Applications of Research (OMAR), the Office of Research on Women's Health (ORWH), and the National Library of Medicine (NLM) are working to assemble a database of trials relevant not only to women's health, but across the spectrum of research. "The goal," says John Ferguson, MD, director of OMAR, "is to improve health care outcomes, and you want to have the best information across the board on which to base patient care decisions."

A December 1993 meeting at NIH, cosponsored by the Agency for Health Care Policy and Research, convened health officials, patient advocates, researchers and administrators of clinical trials registries to review the rationale for registries, exchange information on existing registries, identify users' needs, and explore the problems in setting up and maintaining registries. The logistical obstacles involved in managing registries are formidable, but among the benefits would be a health care system in which evidence from clinical trials can be more rapidly incorporated into clinical practice.

One of the key resources to registries of published clinical trials is the NLM. In recent years, NLM has expanded the number and variety of terms that can be used in indexing and searching the clinical trial literature. In addition, because indexers must rely solely on authors' explicit descriptions of research, the NLM is taking steps to emphasize to editors and authors the need to use terms specific to clinical trials. The NLM, OMAR, and the University of Maryland's Baltimore Cochrane Center are collaborating to "retrotag" already published randomized controlled clinical trial reports that were not so indexed, and are asking journal editors to contribute to the massive task of back searching for such papers.

Ongoing Trials a Greater Challenge Than Those Already Published: Experience with existing U.S. and European databases discussed at the meeting highlighted common problems of managing a database of ongoing clinical trials. At present, registries vary in both the types of studies they include and the information on each trial. The International Collaborative Group on Clinical Trials Registries, a consortium of registry keepers, has suggested a standard core content that could make data collection among registries more consistent.

Gathering and updating the information--and ensuring the resources needed to do so--are difficult challenges. OMAR is looking at its existing inventory of NIH-funded clinical trials with a view toward streamlining data acquisition with an emphasis on protocols, rather than program and funding information, which had been its focus, and making the database easier to update and use.

NIH already has two online clinical trials databases, AIDSTRIALS and PDQ. AIDSTRIALS, a collaborative effort of the National Institute of Allergy and Infectious Diseases, the Food and Drug Administration, the Centers for Disease Control and Prevention and the NLM, currently provides information on about 540 AIDS-related trials. The National Cancer Institute's PDQ provides information on cancer research protocols as well as other resources. (For more information, call the AIDS Clinical Trials Information Service at [800] TRIALS-A, or, for PDQ, [800] 422-6237.)

Internationally, there are about 24 clinical trials registries, most of which focus on AIDS. Registry advocates envision a time when anyone will be able to obtain information on-line on international clinical trials, if not through one unified registry then through a directory of registries like that at the University of Maryland. This registry is not yet on-line, but information is available by contacting Kay Dickersin, PhD (E-mail KDICKERS@UMAB.UMD.EDU, or fax [410] 706-8013). A systematic means of archiving and retrieving the experience of previous and ongoing research is central to wise, timely, and ethical use of therapies and health resources which is essential to health care system reform.

--by Willam R. Harlan, MD Associate Director for Disease Prevention, NIH

Editor's Note: Inquiries may be directed to Charlotte Armstrong, Writer-Editor, NIH, Bldg 31, Room 2B19, Bethesda, MD 20892; telephone (301) 496-8855.