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By Jeannie Baumann
Feb. 19 — Compliance with a legal requirement to post the results of clinical trials on a federally operated website appears to be improving, but more than a third of applicable study results are still missing, according to NIH data posted Feb. 19 by Sen. Charles E. Grassley (R-Iowa).
The overall rate of results reporting of probable, applicable clinical trials (pACTs) is 64 percent since the ClinicalTrials.gov results database went live in September 2008, Francis S. Collins, director of the National Institutes of Health, reported to Grassley. The NIH director said in his Feb. 5 letter that while the compliance level is “not yet what it should be,” the reporting rates have improved over the past several years due to outreach efforts that increase awareness of the requirements. He expects they will continue to improve.
Collins said the NIH remains “deeply committed” to carrying out the requirements of Section 801 of the Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85), which requires the results of most clinical trials that are regulated by the Food and Drug Administration to be posted on ClinicalTrials.gov. Phase I trials of drugs and biological products and small feasibility studies of devices aren't covered by the requirement. The law also requires registration of covered studies and establishment of a database to post adverse events as part of a larger effort to increase the transparency of the clinical trials process.
“Not only does public access provide a way for the public to identify trials in which they may be eligible to participate, it also helps inform future research, improve study design and prevent duplications of unsafe or unsuccessful trials,” Collins wrote to Grassley, who posted the letter Feb. 19. “We also know that enhancing transparency can affirm public trust in clinical research.”
Studies have indicated compliance with Section 801 is generally lacking, with NIH-funded trials at academic centers lagging behind industry (9 LSLR 323, 3/20/15). The data provided by Collins to Grassley generally supported those findings. For calendar years 2013 and 2014, 60 percent of pACT results were posted overall, including:
Collins noted that these numbers aren't necessarily definitive as “current ambiguities in the law and absence of independently verifiable information about all existing clinical trials being conducted worldwide” make it impossible to determine with certainly which clinical trials that are registered with ClinicalTrials.gov qualify as applicable clinical trials under FDAAA.
Collins added that the NIH is working with the FDA to issue a final rule to implement the reporting requirements for clinical trials in Section 801, along with a related draft policy to require all NIH-funded clinical trials to meet those same registration and reporting requirements (08 LSLR 1173, 11/28/14). While he didn't indicate when the final rule and policy would come out, Collins said he expects them to improve compliance with Section 801.
Grassley said in response to Collins's letter that the final rule 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,” Grassley said in his Feb. 19 statement. “The agency should continue to make progress, and I'll continue to monitor the results.”
In response to a question from Grassley in a Dec. 23, 2015, letter, Collins said the NIH has not issued any penalties over the last five years for failing to comply with Section 801. The forthcoming final rule will facilitate NIH enforcement actions, Collins said, adding that the FDA may issue additional monetary fines if the clinical trial falls under the FDA's jurisdiction.
“When a trial is subject only to NIH policy, we will be able to use our own enforcement tools, which include withholding funding of future grants, to ensure compliance,” he said.
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