WASHINGTON (May 16, 2013) – Many clinical trials involving humans are still not registered in a publicly-accessible database and critical study results are not reported, putting people participating in the studies at risk due to lack of information sharing among studies. In order to protect study participants, close dangerous loopholes, and bring certainty and public transparency to life-saving research studies, Rep. Ed Markey (D-Mass.) introduced new legislation to take the errors out of clinical trial reporting.

The Trial and Experimental Studies Transparency (TEST) Act of 2013 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 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.

Clinicaltrials.gov was updated in 2007 to become a mandatory registry, directly addressing issues stemming from a lack of transparency of clinical trials. High-profile examples included Paxil®, Avandia®, and Vioxx® trials, in which safety concerns and negative results were suppressed by the drug companies, leading to injuries to patients and in some cases death.
“If we were issuing a grade on the clinical trials report card, it would be Incomplete,” said Rep. Markey. “Unreported results and missing registrations leave participants, doctors and researchers vulnerable.

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.

--Strengthen reporting requirements so that results from all covered trials are posted on the database within one year of the completion of the trial.

--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.

-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.