Markey, House Dems Introduce Bill to Protect Human Subjects in Clinical Trials
TEST Act ensures disclosure of critical information about clinical trials and complete information about products on market
WASHINGTON, D.C. August 2, 2012– Despite containing valuable information that could benefit patients and protect additional ones from risk, many clinical trials involving human subjects are not registered in a publicly-accessible federal database and are not reporting critical study results. Congressman Edward J. Markey (D-Mass.), senior member of the Energy and Commerce Committee, today introduced H.R. 6272, the Trial and Experimental Studies Transparency (TEST) Act of 2012 to close these clinical trial loopholes and bring certainty and transparency to life-saving research studies. One of these loopholes results in registered trials never reporting study results, putting future human participants at risk if a different company decides to develop the same drug, but without important safety information from the previous study. The TEST Act updates and expands the clinical trial registry data bank – clinicaltrials.gov – with stronger reporting requirements, and requires 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. 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 is co-sponsored by Reps. Henry A. Waxman (D-Calif.), Rosa DeLauro (D-Conn.), and Jan Schakowsky (D-Ill.)....