July 17, 2007
Strong Federal Legislation Necessary to Require Clinical Trial Registries and Results Databases
Public Citizen Report Highlights Weaknesses in Current Databases That Allow Drug Companies to Withhold Unfavorable Results
WASHINGTON, D.C. – Publicly available clinical trial registries and databases of the trials’ outcomes are necessary to counteract the tendency of pharmaceutical companies to suppress unfavorable study results, according to a report released today by Public Citizen. The report compares existing and proposed registries and results databases and provides recommendations for federal legislation now pending before a congressional conference committee.
Clinical trial registry databases are catalogues of hypothesis-testing clinical trials conducted on human subjects. Information about the trial, such as the drug being tested and the purpose of the study, is placed in an online registry before the trial begins and remains available regardless of whether the trial is completed or published.
Results databases provide online repositories for the results of clinical trials whether or not they are published in the medical literature. They allow academics, regulatory bodies, public interest groups or study participants to review completed studies. They can also facilitate analyses that statistically combine other studies to evaluate the safety and efficacy of drugs. One such analysis of the diabetes drug Avandia used GlaxoSmithKline’s results database to demonstrate an increased risk of heart attacks from the drug.
Although the four public registries are generally of high quality, none is a results database, the study found. Conversely, while 12 of the 18 private Web sites included registries and results databases, these sites are voluntary, of variable quality and inconsistent design. Moreover, they are dispersed across the various company sites, forcing potential users to search multiple sites to find information. As with any non-public venture, there are significant questions as to transparency, enforceability and quality assurance.
“Pharmaceutical companies that withhold data about unfavorable study outcomes can cause serious harm,” said Dr. Peter Lurie, deputy director for the Health Research Group at Public Citizen and an author of the report. “In order to educate physicians and protect patients, there must be strong federal legislation to require clinical trial registries and results databases.”
Currently, only federally and privately funded trials of experimental treatments for “serious or life-threatening diseases and conditions” are required to be included in a registry. In 1997, Congress required the National Institutes of Health (NIH) to establish an online registry – ClinicalTrials.gov – for these types of clinical trials. But ClinicalTrials.gov, which has grown significantly in recent years, serves only as a registry, not as a results database, and is voluntary for all other types of trials.
Both the U.S. House and Senate have recently passed bills that seek to formalize the information that must be posted in clinical trial registries and, potentially, results databases. The House bill, H.R. 2900, is better than the Senate bill, S. 1082, in creating and enforcing a registry and results database. Unlike the Senate version, the House bill has an important provision requiring a summary of clinical trials for patients that would describe the most important elements of the study design and results – and the risks involved – in non-scientific terms.
The Senate bill’s approach has the potential to completely gut the results database initiative. It requires a feasibility study for the results database as well as a subsequent “negotiated rulemaking.” The 18-month study would recommend what types of information should be disclosed, the timeframe in which disclosure would occur and how the information would be released. The “negotiated rulemaking” would guarantee involvement by members of the pharmaceutical industry and could lead to an ineffective results database.
“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,” said Lurie. “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.”
READ the report.