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.
"If we were issuing a grade on the clinical trials report card, it would be Incomplete," Markey said in prepared remarks. "Strengthening standards for reporting outcomes will help maintain the trust of clinical trial participants and avoid putting people unnecessarily at risk."
The group, which includes Reps. Henry Waxman (D-Calif.), Rosa DeLauro (D-Conn.), and Jan Schakowsky (D-Ill.), warned that the concealed information prevents future researchers from being informed before undertaking trials of their own.
Researchers experimenting with a new device or drug may not have the benefit of knowing how a similar device may have harmed a patient in the past, the Reps. warned. Boosting reporting requirements could make the ClinicalTrials.gov registry, established through legislation in 2007, a stronger tool in helping protect patients and progress medical research.
"Unreported results and missing registrations leave participants, doctors and researchers vulnerable," Markey added. "Significant strides have been made since we established this registry in 2007, and the TEST Act will create additional certainty regarding registration and reporting requirements and promote transparency in clinical trials."
The measure also won the support of the Patient, Consumer and Public Health Coalition and Consumers United for Evidence-Based Healthcare, which have the backing of a long list of groups including the Union of Concerned Scientists, Consumers Union and Public Citizen, among others.
According to the legislation, the TEST Act propose to:
- 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
- Instruct the Secretary of HHS to undergo a rulemaking to 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
- Instruct NIH and the FDA to provide a report to Congress regarding the implementation and compliance with the database requirements.
The bill is the latest move in Markey’s long involvement in bolstering regulation around human testing. In 1986 he released a report entitled "American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens," in which he documented radiation experiments conducted on more than 700 patients and offered recommendations on protections for clinical trial subjects.
Markey, who is occasionally at odds with the medical device industry, is also the author of the Safety of Untested & New Devices Act, which would give the FDA the power to request that companies submitting new devices speak for any recalls or safety issues in predicate products. It would also grant the FDA authority to reject claims of equivalence if the predicate device, or its predicates further down the line, had been corrected, removed or were undergoing regulatory action for design flaws.