Democrats in the House are proposing changes to the U.S.'s clinical trial registry, a move that would impose stronger reporting requirements and mandate that foreign studies meet the same standards as domestic ones if they're conducted for FDA approval.
The Trial and Experimental Studies Transparency Act, introduced by Rep. Edward Markey (D-MA), is designed to bolster ClinicalTrials.gov, the feds' public data bank. Under current regulations, many human trials conducted around the world aren't recorded in the searchable database, meaning researchers often duplicate the same studies, unaware of risks they may pose for participants.
Most important to many in the CRO world, though, is the requirement that foreign-conducted trials conform to U.S. regulations. In 2008, about 80% of drugs entering the American market were tested overseas, and more and more medical devices are following the same trend, according to Markey's office. Many of those trials weren't required to list their data on ClinicalTrials.gov, and the congressman's bill would change all that.
"If we were issuing a grade on the clinical trials report card, it would be Incomplete," Markey said in a statement. "Unreported results and missing registrations leave participants, doctors and researchers vulnerable."
However, as Ed Silverman writes in Pharmalot, it's unclear whether the bill, sponsored solely by Democrats, has a future in the Republican-controlled House. And Markey and company are unlikely to find any support among members of the industry, which generally opposes any regulations that would mandate additional data disclosure.
- read Markey's statement
- get Pharmalot's take