A quartet of House Democrats propose new legislation that would require all human clinical trials, including those conducted overseas, to be reported to ClinicalTrials.gov.
A quartet of House Democrats set out to close loopholes in the U.S. government's clinical trial reporting requirements to ensure that all human studies are publicly disclosed online.
Current rules aren't robust enough, according to the group, led by Rep. Edward Markey (D-Mass.), senior member of the Energy & Commerce Committee. Certain studies conducted overseas need not disclose details or study results, possibly putting future trial participants at risk, according to a press release.
The proposed Trial & Experimental Studies Transparency Act would require medical device and drug makers to report all studies and results publicly through the government's registry, ClinicalTrials.gov, if the studies are used to support an FDA application.