The final rule, which was issued by the US Department of Health and Human Services, will go into effect January 18, 2017 and will mark a “change in business as usual,” Francis Collins, M.D., Ph.D., the director of the National Institutes of Health (NIH) said during a media telebriefing.
Failure to comply with the new rule may have legal consequences, including civil monetary penalties.
The NIH also released a complementary policy for registering and submitting summary results information to ClinicalTrials.gov.
Upholding a pledge
During the telebriefing, Collins expressed excitement about the news, explaining that the new rule will “maximize the value of clinical trials and honor trial participants.”
“Clinical trials are vital to medical advances, and increasing the availability of information about clinical trials is good for patients, for the public and for science,” he said.
Specifically, Collins noted that often “just as much, maybe more” is learned from clinical trials in which a product or intervention is deemed unsafe or ineffective, as is learned from successful trials.
“So, sharing the results of information from clinical trials is how researchers from different disciplines and countries form collaborations, learn from others, identify new scientific opportunities, and work to turn newly discovered information into shared knowledge and practical advances,” he explained.
“We, as a community, have had a disappointing track record on making those results available,” he said. “Such low reporting of clinical trial information is simply not acceptable.”
Robert Califf, MD, MACC, the Food and Drug Administration's (FDA) commissioner of food and drugs echoed Collins’ comments, stating “This is really an important day,” calling the final rule “very significant.”
“Providing this information [clinical trial results] to the public gives us a tremendous chance to improve the entire system and do a better job with diagnostics and therapeutics,” he said.
“The public’s participation in clinical trials makes it possible to further advance scientific progress … The new rules outlined in the final rule are expected to provide greater transparency,” Califf added.
However, he explained the real purpose of the changes is to “hold true to the pledge” made to study participants.
John Lewis, senior vice president, Policy and Public Affairs, Association of Clinical Research Organizations (ACRO), told us he expects the bigger influence on advancing research will come from making ClinicalTrials.gov more useful for patients and physicians looking for new and active clinical trials.
To help prepare for the increased volume of submissions, the National Library of Medicine is making workflow improvements.
Nick Payton at Comprehend Systems told us he expects an indirect byproduct of this general move toward data quality and transparency will be additional investment in more flexible IT capable of aggregating data across systems and studies.
“The new rules create additional momentum behind heightened emphasis on data quality and transparency,” Nick Payton at Comprehend Systems. “Because data is the output of clinical trials, data quality can influence the outcome of trials, which, in turn, impacts the extent to which patients ultimately receive treatment they need.”
As such, Payton explained additional emphasis on and prioritization of data quality will therefore hold broader implications for the life sciences industry. “These regulations are another example of changing standards for data quality in the industry,” he added.
For more information, visit www.nih.gov.