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The government's clinical trial database

The National Institutes of Health have assembled a database of clinical trials and made it available to the public through the internet. Anyone can visit their comprehensive web site, at http://www.clinicaltrials.gov, to learn about which trials are recruiting test subjects, actively studying drug effects, or have completed their trials. In addition, visitors can learn much more about how clinical trials work, how to list a trial and how to find news on current or completed trials.

A main feature of the Clinical Trials website is the trial study search functionality. The basic search allows users to find studies based on any combination of the medical condition under investigation, the drug intervention being tested in the trial, and the location of the study. The advanced search gives users more search criteria such as search by sponsor, trial phase, funding agency, date range and age group(s) available for the study. The category search lets visitors find studies based on either an alphabetical or a regional list of conditions, drug interventions, study sponsors and locations. The site also offers a map-based search function to aid users in finding trials in their area. In all, the Clinical Trials site has data on over 65,000 studies in over 150 countries.  Note that clinical trials include those for diagnosis, etiology, and therapy for various diseases.

While the search functionality helps the general public find and learn about the status of current trials, the site also offers those entities that organize and recruit for clinical trials the requisite forms needed to post their data to the web site through its Protocol Registration System (PRS), found at http://prsinfo.clinicaltrials.gov. Any organization or study sponsor (doctor, hospital, pharmaceutical firm, university, etc.) that currently has an account with PRS can log into the system and enter their data into the Clinical Trials database. Once a PRS administrator reviews and approved the data, that data becomes available to visitors using the search functionality. If a study sponsor does not have a PRS account, a sponsor contact can apply for one free of charge. After the sponsor establishes an account, they can also create multiple user accounts so that users across borders, oceans and job titles can post relevant information on the study.

Although the NIH provides a useful service with this web site in terms of dispersing clinical trial data, it does not provide tacit approval or endorsement for any trial or treatment listed. Neither is this site a matching service between potential test subjects and organizations conducting clinical trials. Each trial sponsor must select human test subjects based on the condition being studied, the treatment under review and the patient's medical history. Moreover, the responsibility for conducting each study within prescribed ethical and safety protocols lies with the study sponsor, not with NIH. The Clinical Trials web site serves as a repository for study data in conjunction with the National Library of Medicine and the US Food and Drug Administration.

The Clinical Trials web site gives patients, doctors, sponsors and investigators the tools that they need to make educated, informed decisions regarding their participation in medical treatment studies from around the world. Such an educational resource is critical to both the health of the subject and the integrity of the study data.

 

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Last updated Fri, 03/27/2009 - 16:13