"ClinicalTrials.gov" Launched

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When 49-year-old Margaret, a Maryland attorney and mother of two, was diagnosed with thyroid cancer, she was interested in investigating the potential of clinical trials.

But after doing some sleuthing, she couldn't find a central location where information on such studies was available. She finally called a friend who worked at NIH, who made inquiries and found a new study evaluating thyroid cancer treatments. Margaret enrolled in the trial and, three years later, remains cancer-free. But without her friend's "inside scoop," she admits she would never have known of the trial's existence.

As of February 29th, everyone with access to a computer and the Internet could get the "inside scoop." On that date, NLM launched a consumer-friendly resource, ClinicalTrials.gov. This online database contains information on over 4,000 federal and private scientific studies involving human subjects at more than 47,000 locations nationwide. You can access the database via the NLM Web site (www.nlm.nih.gov) or directly, at clinicaltrials.gov.

"Through this new database, NIH offers up-to-date information on promising patient-oriented research on hundreds of diseases and conditions," noted Acting National Institutes of Health Director Ruth L. Kirschstein, MD. "Most of the trials 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."

ClinicalTrials.gov provides patients, families and members of the public easy access to information about the location of clinical trials, their design and purpose, criteria for participation and, in many cases, further information about the disease and treatment under study. There are also links to individuals responsible for recruiting participants for each study.

"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, MD, Director of the National Library of Medicine, which developed and administered the new database.

"ClinicalTrials.gov will benefit trials participants, researchers, health care professionals and, over time, the general public."

Thanks in part to a successful media campaign, ClinicalTrials.gov has already proved to be quite popular. At NEWSLINE press time, it had logged nearly 4 million hits.

ClinicalTrials.gov grew out of 1997 legislation requiring the Department of Health and Human Services, through NIH, to establish a registry for both federally and privately funded trials "of experimental treatments for serious or life-threatening diseases and conditions," thereby broadening the public's access to information about clinical trials to a wide range of diseases.

Alexa T. McCray, PhD, who directs the ClinicalTrials.gov project at NLM, commented, "The project is proceeding in several major phases. In the first phase, we were interested in collecting information primarily about the 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 of the project is well underway. In the next phase we will include non-NIH sponsored trials from other Federal agencies and private industry." Dr. McCray heads NLM's Lister Hill National Center for Biomedical Communications. ClinicalTrials.gov is a completely confidential Web site. No registration or personal identification of any kind is required. People who search the site will not be contacted by the sponsors of clinical trials or by anyone else.

More information about ClinicalTrials.gov, in the form of a "Q&A" document, is available from publicinfo@nlm.nih.gov or by calling 301- 496-6308. It is also linked to a press release about the new database, available on the Web at: www.nlm.nih.gov/news/press_releases/clintrlpr00.html .

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