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www.fdanews.com/articles/96344-public-citizen-calls-for-clinical-trial-registry-and-results-databases-in-legislation

Public Citizen Calls for Clinical Trial Registry and Results Databases in Legislation

July 25, 2007

Legislation creating publicly available clinical trial results and registries databases is necessary to prevent pharmaceutical companies from concealing unfavorable study results, Public Citizen said in a report.

The report compares 22 current databases and gives recommendations for pending legislation that would regulate the creation of results and clinical trial registry databases. Of the 22 existing databases examined, four are public and 18 are private. The four public registries are “generally of high quality,” but none contain a results database, the report said. However, 17 of the private websites have a results database and 13 have a clinical trial registry.

While 12 of 18 private websites include a registry and results databases, the sites are voluntary and have inconsistent design and quality, raising questions about transparency and quality assurance, the report said. In addition, the registries are distributed throughout different companies’ websites, making them difficult to find and search.

Two bills that would regulate results and registry databases, H.R. 2900 and S. 1082, are pending before a conference committee. A spokesman for the Senate Health, Education, Labor and Pensions committee said the members of the conference committee have not been chosen yet.

Public Citizen said it prefers the House version of the bill because it would require a summary of clinical trials describing the most important elements of the study design, results and the risks in nontechnical language. The bill would also require the databases to be created in one year, while S. 1082 calls for a study to see what creating the databases would require and gives the FDA two years and six months to implement them.

The report may have left out some websites or missed aspects of existing websites, because there is no comprehensive list of results and registry databases, Public Citizen added. The report can be seen at www.citizen.org/publications/release.cfm?ID=7534.