Legislation to Protect Subjects in Clinical Trials Introduced

Legislation designed to protect clinical trial study participants, close dangerous loopholes, and bring certainty and public transparency to life-saving research studies, has been introduced, according to a statement by the bill’s sponsors. The Trial and Experimental Studies Transparency (TEST) Act of 2013 updates and expands clinicaltrials.gov, the clinical trial registry data bank with stronger reporting requirements, and requires that all foreign clinical studies meet the same registration and reporting requirements as domestic trials if they are used to support an application to market a product in the United States. Eighty percent of the drugs entering the U.S. market in 2008 were clinically tested overseas and a growing number of device trials are also moving abroad. Many of these trials are not required to be registered with the clinical trials database.

The TEST Act, introduced by Rep. Ed Markey (D-Mass.), is co-sponsored by Reps. Henry A. Waxman (D-Calif.), Rosa DeLauro (D-Conn.), and Jan Schakowsky (D-Ill.). A previous version of the legislation was introduced last year.

“If we were issuing a grade on the clinical trials report card, it would be Incomplete,” said Markey, senior member of the Energy and Commerce Committee in the press announcement. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable. Significant strides have been made since we established this registry in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials. Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk. I look forward to working with my colleagues on this legislation.”

According to sponsors, the TEST Act will require all interventional biomedical studies on humans to be registered with the database before the first participant is enrolled in the trial. It will strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial and provide for delayed submission of results (up to two years after trial completion) for trials on medical interventions that have never before been approved for any use. In addition, the sponsors report, the Act will instruct the Secretary of HHS to undergo a rulemaking to require foreign trials that are used to support an application for marketing in the U.S. to comply with the registration and reporting requirements of the database and instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements.