US launches new clinical trials database

The US National Institutes of Health and the Food and Drug Administration have jointly set up a database of all US clinical trials for serious illnesses, stated to be the most comprehensive central listing available.

The action is a result of the Food and Drug Modernization Act of 1997, which required the Department of Health and Human Services to establish a registry of the clinical trials being conducted for both the governmental and private sectors.

"This is the single place you can go where the most important information, we hope, will be available to everybody," said Dr Donald Lindberg of the National Library of Medicine, the largest medical library in the world, which is running the registry.

The website contains information on about 4000 studies being conducted at 47 000 sites nationwide, most of which are sponsored by the National Institutes of Health or universities. More studies, particularly trials run by drug companies, will likely be added.

Access to the new registry is free (http://clinicaltrials.gov), and the new registry will be regularly updated. … "Users are not asked to provide personal information, nor will they be sent unsolicited material."

A freephone number for the database is planned for 2001. The website also provides information for people considering participating in a trial. It has a list of 20 frequently asked questions and answers, including: what is a clinical trial; what is a protocol; what is informed consent; what is a control or control group; what protections are there for participants?

The website also contains information on understanding clinical trials from a patient's perspective, by Patty Delaney, a 10 year sur- vivor of Hodgkin's disease and member of the Food and Drug Administration's cancer liaison programme in the Office of Special Health Issues.

Fred Charatan, Florida


studentBMJ 2000;08:89-130 April ISSN 0966-6494