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Publicly-available clinical trial registries and databases of trials outcomes are needed in order to counteract pharmaceutical companies’ “suppression” of unfavourable study results, US consumer group Public Citizen has claimed.
Dr Peter Lurie, deputy director of Public Citizen’s health research group, said: “Pharmaceutical companies that withhold data about unfavourable study outcomes can cause serious harm. In order to educate physicians and protect patients, there must be strong Federal legislation to require clinical trial registries and results databases.”
An investigation by the group into currently available US registries and databases has found that the four public registries are generally of high quality, but none is a results database. Public Citizen says 12 of the 18 private websites include registries and results databases, but they are voluntary and of variable quality and inconsistent design. Also, as they are dispersed across various company sites, potential users have to search multiple sites in order to find information.
“As with any non-public venture, there are significant questions as to transparency, enforceability and quality assurance,” the group comments.
Currently, only Federally and privately-funded trials of experimental treatments for serious or life-threatening diseases and conditions must be included in a registry. ClinicalTrials.gov, the on-line registry established by the US National Institutes of Health (NIH) in 1997 for such trials, has grown significantly in recent years but serves only as a registry, not as a results database, and is voluntary for all other types of trials.
Both the US House of Representatives and Senate have recently passed bills seeking to formalise the information that must be posted in clinical trial registries and, potentially, results databases. Public Citizen says the House bill, HR 2900, is better than the Senate’s version, S 1082, because it requires a summary of clinical trials for patients, describing the most important elements of the study design and results, and the risks involved, in nonscientific terms.
The Senate bill, on the other hand, “has the potential to completely gut the results database initiative,” the group warns. It requires an 18-month feasibility study for the results database, plus a subsequent “negotiated rulemaking” which would guarantee involvement by members of the pharmaceutical industry and could lead to an ineffective results database, it adds.
“A weak Federal law, such as the current Senate bill, could cripple the recent push for registry and results posting by deferring the crucial details of the results database to reports and industry-influenced proceedings. Congress should put patient health above the pharmaceutical industry’s bottom line and pass a bill with strong guidelines for the disclosure of all clinical trials and their results,” says Dr Lurie.
PharmaTimes 2/8/2007
