Awebsite launched by the National Institutes of Health will link patients and clinical trials. The new site (http://clinicaltrials.gov/) is the government’s first attempt to make information about medical studies easily available to consumers.
The website will contain information on >4000 federal and private medical studies taking place at >47 000 locations nationwide. Of the 4000 studies, officials estimate that 2800 are actively recruiting patients. The Acting Director of the National Institutes of Health (NIH), Ruth L. Kirschstein, MD, 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 4000 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.”
Donald A. Lindberg, MD, director of the NIH’s National Library of Medicine, helped develop and currently administers the new database. He said the clinical trial database will not only meet the needs of patients, but advance the cause of science as well. “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. clinicaltrials.gov is a resource that will benefit trial participants, researchers, healthcare professionals and, over time, the general public.”
In 1997, Congress passed legislation requiring the US Department of Health and Human Services to develop mechanisms to give the public broad access to information about clinical trials on a wide range of disease. The legislation required that the department establish a registry for federally and privately funded trials on drugs for serious or life-threatening conditions. The new website/database, however, includes studies involving many conditions, not just those mandated by Congress. Officials said they wanted the database to be the most comprehensive one available on the Internet.
Alexa T. McCray, PhD, who directs the project for the National Library of Medicine, said the first phase of the project involved trials funded by the NIH or being conducted on the NIH campus in Bethesda, Md. The next phase will include trials in other federal agencies and those funded by private industry.
The website is confidential and requires no registration or personal identification. Its directors expect the website to attract the attention of people with serious illnesses, their families, advocacy groups, the media, and healthcare professionals.
In the listing for each study, the website outlines the purpose of the trial, whether it is actively recruiting patients, the criteria for patient participation, the location of the study, and contact information, as well as the specific disease or condition involved, the drug or therapy under study, and the phase of the trial. The website provides information only. Contact people and, sometimes, e-mail addresses are included in the listing to allow patients to contact the individuals conducting the trial to determine if the study is an appropriate one for them.
People who do not own a computer are expected to access the database in libraries, community health centers, cybercafes, and other public outlets at which Internet access is made available.
- Copyright © 2000 by American Heart Association