Clinical Trials Reporting and Publication (CRS Report for Congress)
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Release Date |
Revised July 12, 2007 |
Report Number |
RL32832 |
Report Type |
Report |
Authors |
Erin D. Williams, Domestic Social Policy Division |
Source Agency |
Congressional Research Service |
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Summary:
The central issue before Congress with respect to clinical trials reporting andpublication is how to balance the potential beneficial public health effects ofrequiring that clinical trials data be made public with the burdens that suchrequirements may place on companies and their innovation. Clinical trials, whichare conducted regularly to test the effects of new pharmaceuticals and medicaldevices, cost a significant amount of money, and by their nature may present somerisk to the people who participate in them. Manufacturers as well as medical journaleditors have been reluctant to publish clinical trial data indicating that products indevelopment are harmful or ineffective. The availability of such information mightsave a duplication of effort and studies that harm or fail to help patients.