Improving Public Access to Clinical Trial Information

In May, a study in the New England Journal of Medicine informed the public about the link between the diabetes drug Avandia and heart attacks.

The authors of the article didn’t conduct an independent analysis to discover the link, it analyzed and compiled data from a variety of sources – including a clinical trial registry database maintained by Avandia’s drugmaker, GlaxoSmithKline.

Publicly available clinical trial registries and databases of the trials’ outcomes exist to prevent pharmaceutical companies from suppressing unfavorable study results.

Clinical trial registry databases contain information about the trial, such as the drug being tested and the study’s purpose, before the trial begins. The information is available regardless of whether the trial is completed.  Ideally, when and if clinical trials are completed, the results would be logged in another database, whether or not they are published in medical literature.

However, the problem with clinical registry databases is that they all contain different information. Public Citizen wants the databases to be standardized and government-regulated to make sure they contain the same kinds of information, according to a new report released in July.

“All of the currently available clinical trial registries and results databases are inadequate,” according to the report.

Access to complete, comprehensive clinical trials registries is essential for scientists who review studies to see if any health risks are overlooked, such as in the case of Avandia. The database for Avandia contained enough easily searchable information about the drug to make the study successful, but this may not always be the case. That’s why these registries and results databases should be regulated, according to Public Citizen.

Public Citizen’s report compares existing and proposed registries and results databases, finding that while private registries and databases exist, they are of variable quality. Further, because these private registries are voluntary, they are designed inconsistently and information is included inconsistently. This can limit the accessibility of the information because online visitors have to search harder for information which, in some registries, may not even exist. As with any non-public venture, there are significant questions as to transparency, enforceability and quality assurance.

The lack of standardized databases for clinical trial registries and results prevents pharmaceutical companies from truly being held accountable, according to Public Citizen. 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. (There are four public registries which are generally of high quality, but none is a results database, the report found.)

“Requiring full disclosure from the pharmaceutical companies prevents them from manipulating information by purposely excluding results that conflict with their business models,” said Dr. Peter Lurie, deputy director of the Health Research Group at Public Citizen and co-author of the report. “Without any secrets, other members of the scientific community can monitor progress and will know about any changes or abandoned studies, which would make the public more comfortable with the actions of these mistrusted corporate giants. Further, registries help recruit patients into clinical trials, which is also important.”

The only way to force standardized databases is for Congress to enact legislation, which would also assess penalties for non-compliance, according to Public Citizen.

Both the US 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 standardized 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.

“We hope that Congress passes a law that will help to make the information in these databases more consistent. The law also needs to have an enforcement mechanism,” Lurie said. “Without such a mechanism, pharmaceutical companies will have no motivation to release all the information about their clinical trials.”

To read the report, visit www.citizen.org/publications/release.cfm?ID=7534.