US Senator Charles Grassley called Friday for the National Institutes of Health to boost its efforts to compel public disclosure of results from human experiments, citing a jump in researchers’ compliance with a federal reporting law in response to a recent STAT investigation on the widespread failure of scientists to share clinical trial outcomes.
Earlier this week, the NIH said that in December and January, researchers had reported results for 25 percent more clinical trials than during the same period a year earlier, and attributed the improvement partly to the STAT coverage.
“It’s good news that media disclosure encouraged more reporting of clinical trial results. Investigative reporting deserves a lot of credit for affecting action in many fields. But NIH shouldn’t rely on media coverage to do its job here,” Grassley, an Iowa Republican and longtime advocate of openness in clinical research, said in a written statement.
STAT reported in December that Stanford University, Memorial Sloan Kettering Cancer Center, and other top academic and nonprofit research institutions — as well as major pharmaceutical companies — routinely have flouted a federal law that requires results from human trials to be reported to the government website ClincalTrials.gov. Several of the top recipients of NIH grants reported their results after the legal deadlines — or not at all — 95 percent of the time since reporting became mandatory in 2008.
The NIH can withhold grants from institutions that do not comply with the law, but has yet to use that power. The agency is working to clarify and tighten rules for reporting, and has said it intends to enforce the law on its grantees and internal researchers more vigorously as early as this spring.
Grassley opened a dialogue with NIH Director Dr. Francis Collins in December, following publication of the STAT investigation.
“Although reporting of clinical trial information to ClinicalTrials.gov is not yet what it should be, our data suggest that the rates of results reporting over the last several years are improving,” due partly to agency outreach and training for clinical researchers, Collins replied.
Better enforcement, Grassley said Friday, “sounds like a critical step to bring along outliers who don’t respond to other methods. NIH should continue its recent push to lead by example and report clinical trial results from its own researchers. It’s unclear why NIH has been behind in making this system as strong as it should be, but I appreciate the agency’s commitment to promoting greater reporting for patients’ benefit.”