Grassley Notes Need for Continued Increased Reporting of Clinical Trial Results

Statement

Sen. Chuck Grassley is tracking how well scientific researchers report clinical trial results to the National Institutes of Health (NIH) in light of an investigative report showing lagging reporting. Researchers are required to report results to an NIH database, clinicaltrials.gov, for the benefit of patients and doctors. The news outlet STAT documented poor compliance by several leading outlets and then noted improved reporting after media coverage and public pressure. Grassley made the following comment on the improved reporting and his correspondence with NIH.

"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. Media coverage comes and goes, while NIH's obligation to ensure compliance with reporting requirements is constant. NIH's outreach and education methods to get better compliance are welcome.

"In addition, NIH has indicated it will be better equipped to take more enforcement action once a final rule outlining possible enforcement steps is in place. That 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. The agency should continue to make progress, and I'll continue to monitor the results."

Source