Posted 03 August 2012
By Alexander Gaffney
A new bill proposed in the US House of Representatives would require clinical trial sponsors to publish the results of any clinical trial-domestic or foreign-conducted in support of a product application before the US Food and Drug Administration (FDA).
The bill, the Trial and Experimental Studies Transparency (TEST) Act of 2012, was introduced by Rep. Ed Markey (D-MA), a member of the House Energy and Commerce Committee whose oversight duties include the healthcare industry and FDA.
In a statement, Markey said the bill is intended to close what he referred to as "clinical trial loopholes" allowing companies to only disclose trials data favorable to its products. This, added Markey, is to the detriment of patients who may be enrolled in a duplicative study in the future without being made aware of the known safety risks.
"Unreported results and missing registrations leave participants, doctors and researchers vulnerable," Markey said. "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."
Foreign Clinical Trial Data Reporting Required
The bill would also expand requirements for companies to register clinical trials with a government database to include foreign-based trials conducted in support of an FDA product application.
"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," Markey explained. The congressman said this is necessary to combat an increasing trend of clinical trials being conducted oversees.
Sponsors would be required to list all studies with the database before the first patient is enrolled in a study, and the bill would mandate the results of the trial be posted to clinicaltrials.gov within one year of the conclusion of the trial. Studies on novel compounds or devices would be granted an extra year to report. Any requests to postpone or delay results would be made available to the public.
The US Department of Health and Human Services (DHHS) would be required to implement final regulations regarding the foreign clinical trial components of the law no later than one year after the passage of the law.