A Bill To Strengthen Patient Safety In Clinical Trials

In a bid to strengthen standards for clinical trials, four Congressional Democrats have introduced a bill they contend would close loopholes that allow study results to go unreported. Known as Trial and Experimental Studies Transparency Act, the legislation would require that all foreign clinical studies meet the same requirements as domestic trials if they are used to support an application for marketing in the United States. The idea is to update ClinicalTrials.gov.

One loophole cited, for instance, means that results in registered trials are not reported, which may place future trial participants at risk if another drugmaker chooses to develop the same drug, but lacks safety data from the previous study. They note that 80 percent of the drugs that entered the US market in 2008 were clinically tested overseas, but many trials were not required to be registered with ClinicalTrials.gov.

"Unreported results and missing registrations leave participants, doctors and researchers vulnerable. Significant strides have been made since we established this registry (ClinicalTrials.gov) in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials," says Ed Markey, a Massachusetts Democrat who introduced the bill, in a statement.

The move comes after several scandals revealed that clinical trial data for various drugs was not fully disclosed and only became known after litigation or studies, such as meta-analyses, were published in medical journals. Examples included the Vioxx painkiller and the Avandia diabetes pill. The issue has consequently plagued the pharmaceutical industry and, at times, undermined its ability to maintain needed trust with physicians and patients.

"This bill would strengthen enforcement of important mechanisms to improve patient and consumer safety. Not only would all clinical trials be required to report their data regardless of FDA approval, it would allow for analysis of the safety as well as efficacy of drugs and devices," says Illinois Democrat Jan Schakowsky. "Increasing transparency while clarifying the registration and reporting requirements will maintain the Clinical Trial Registry Data Bank as a trusted resource” (here is the proposed legislation).

Whether the bill stands a chance of passage is unclear. There are no Republican sponsors and the pharmaceutical industry has been reluctant to support measures that require disclosure of additional data, especially if there is an argument to be made about data that can be considered proprietary. Nonetheless, patient safety resonates more so than ever in the wake of the various scandals and drugmakers may find themselves on the defensive by opposing disclosure.