Congressional Democrats are seeking to tighten clinical trial reporting requirements and bolster the massive online clinical trial registry data bank, Clinicaltrials.gov, by closing perceived loopholes that they say put trial participants at risk.
The Trial and Experimental Studies Transparency (TEST) Act of 2012 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.
Clinical research is becoming increasingly global, meaning that any modification to current trial reporting requirements would impact a growing number of trials.
Between 40 percent and 65 percent of clinical trials investigating FDA-regulated products were conducted outside the United States as of June 2010, according to The Department of Health and Human Services Office of the Inspector General. Many of these trials are not required to be registered with the clinical trials database, say TEST Act backers.
Congressman Edward Markey (D-Mass.) introduced the act. Markey says he is concerned that “unreported results and missing registrations leave participants, doctors and researchers vulnerable.” Strengthening standards for reporting outcomes would build trust with clinical trial participants and avoid putting people unnecessarily at risk, he says.
In addition to requiring the registration of foreign trials, the legislation would require all interventional biomedical studies on humans to be registered with the database before the first trial participant is enrolled and instruct the National Institutes of Health and the U.S. Food and Drug administration to provide a report to Congress regarding the implementation and compliance with the database requirements.
“The Clinical Trial Registry Data Bank is a valuable source of public information on human clinical trials,” says Representative Rosa DeLauro (D-Connecticut.), one of the Act’s co-sponsors. “Closing loopholes and strengthening reporting standards will help both Americans who want to do their due diligence on a particular drug or device and researchers evaluating the safety or efficacy of a drug.”
Representatives Henry Waxman (D-California.), and Jan Schakowsky (D-Illinois) are also co-sponsoring the legislation.
Groups backing the bill so far include The Patient, Consumer and Public Health Coalition and Consumers United for Evidence-Based Healthcare, whose members include groups such as Breast Cancer Action, Consumers Union, and the Union of Concerned Scientists.
The Association of Clinical Research Organizations, whose membership includes many of the companies that drugmakers contract with to run global clinical trials, such as Covance, Parexel International, and Quintiles, has not yet taken a position on the Act, a spokesman said.
August 09, 2012