Diabetes Dateline

New Database Provides Information About Research Studies

The National Institutes of Health (NIH) has launched the first phase of a new database for consumers, ClinicalTrials.gov, which has information on more than 4,000 Federal and private medical studies involving patients and others at more than 47,000 locations throughout the country.

ClinicalTrials.gov provides consumers with access to information about the design, purpose, and location of clinical trials; criteria for participation; the disease and treatment (drug or other therapy) being studied; and the phase of the trial. Links to those responsible for recruiting participants are also provided. Even trials in progress that are not currently accepting new patients are included to help patients identify medical centers where research is being conducted.

Clinical trials are medical research studies designed to evaluate the safety and effectiveness of new drugs, medical procedures, or other means of treating, diagnosing, or preventing diseases. Such studies help scientists learn how patients respond to medications or therapy and may lead to new or improved treatments. All clinical trials have criteria, or guidelines, that must be met before a person is eligible to participate. Guidelines can include factors such as age, medical history, type of disease, and current medical condition. Some research studies seek volunteers who have the illnesses or conditions that will be studied in the trial, while others need healthy volunteers.

Acting NIH Director Ruth L. Kirschstein, M.D., said, "Through this new database, NIH offers up-to-date information on promising patient-oriented research on hundreds of diseases and conditions. Most of the 4,000 clinical trials now in the database are funded by NIH Institutes and Centers and result from a long, fruitful partnership between NIH and the American people who support and participate in our work."

"If we are to continue making the giant strides in diagnosis, treatment, and cure of illness that marked the last century, we must have active participation in clinical trials by well-informed volunteers," said Donald A.B. Lindberg, M.D., director of NIH's National Library of Medicine, which developed and administers the new database. "ClinicalTrials.gov is a resource that will benefit trial participants, researchers, health care professionals, and, over time, the general public."

ClinicalTrials.gov is also available through the National Library of Medicine's web site at www.nlm.nih.gov and through its consumer health information service, MEDLINEplus at http://medlineplus.gov. This site provides extensive links to information about 350 diseases and conditions, much of it from NIH Institutes and Centers.

"The project is proceeding in several major phases," noted Alexa T. McCray, Ph.D., who directs the ClinicalTrials.gov project at the National Library of Medicine. "In the first phase we were interested in collecting information primarily about studies that are being funded by NIH or that are being conducted right here on the NIH campus. With the release of ClinicalTrials.gov, the first phase is well under way. In the next phase we will include non-NIH-sponsored trials from other Federal agencies and private industry."

The database currently includes a number of privately funded AIDS and cancer studies, as well as some trials being conducted by other agencies and universities, and a few international trials.

ClinicalTrials.gov is a direct result of the Food and Drug Administration (FDA) Modernization Act of 1997, which required the Department of Health and Human Services, through NIH, to broaden the public's access to information about clinical trials on a wide range of diseases.

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