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Effective Date for Medical Device Clinical Trials Rules Included in HHS Regulatory Agenda

June 11, 2018

HHS will publish its semi-annual regulatory agenda on Monday, and it includes a February 21, 2019, effective date for a new rule that will require that data from medical device studies conducted outside the U.S. be gathered in accordance with good clinical practices, including review and approval from an independent ethics committee and well-documented informed consent. The agency’s final rule applies to data intended to support IDE applications, 510(k) submissions, and de novo classification requests, as well as applications for premarket approval, product development protocols and humanitarian device exemptions. It also applies to bench and in vitro diagnostic studies of de-identified specimens. The new mandates would replace the current pre-market approval regulations that require clinical studies to conform to the Declaration of Helsinki or the law of the country where the research is conducted, whichever carries greater protection for human subjects, the FDA said. The rule does not apply to all clinical investigations performed overseas, but only sets criteria for FDA acceptance of data used to support device marketing applications or submissions.

NICE’s Service for New Product Economic Model Review Wins First Endorsement
UK regulators have won their first endorsement for their new peer-reviewed service designed to help clinical researchers put together more thorough studies for drugs, devices, diagnostics and treatments. The National Institute for Health and Care Excellence launched what it called PRIMA — Preliminary Independent Model Advice — as a service last December. It’s designed to help researchers “ensure the quality of their model structure, coding, usability and transparency.” On Thursday, regulators announce that drug company Takeda had endorsed the service, after completing two PRIMA projects. “We appreciated the PRIMA team’s engaging and flexible approach at this pivotal stage in development and look forward to using the service as part of our model development going forward,” the company said in a news release. Takeda was one of the first companies to test PRIMA.

Market Pressures, IP Rights Depriving Public of Key Data, Group Claims
Results from nearly 40 percent of clinical trials for Crohn’s Disease remain publicly unavailable —further proof that market pressures are depriving the public of important health data, a public advocacy group is claiming. The Center for Economic and Policy Research, a Washington, DC-based think tank, wanted to get a handle on whether drug companies’ intellectual property rights was in conflict with the public’s right to know about safety. The group selected Crohn’s Disease as the lens to which the view the problem. Researchers found that of the 53 trials published at the FDA’s ClinicalTrials.gov site, only 32 had led to published journal pieces as of January, 2018. Of those trials that had led to published pieces, there were still information gaps. “The other studies did not indicate, for example, whether the treatment was more effective for men than women or for younger people than older people,” the center said in announcing its findings. “The lack of transparency surrounding drug safety and efficacy data is an enormous loss to potential users of data, etiher clinicians or other investigators,” the group said. “As a policy matter, the government could require full disclosure of test results for any study receiving any form of government funding.” You can read the group’s full report here: http://www.fdanews.com/ext/resources/files/2018/06-08-18-CEPR.pdf?1528468800.

Clinical Trials Should Focus on Organoids, Study Group Urges
Clinical trial funding should focus on human-based methods, such as organoids, in order to help improve the world’s drug pipeline, a panel of researchers and trial experts has agreed. Representatives from the Humane Society, the National Institutes of Health, the FDA and others who met at the BioMed21 Collaboration workshop also agreed that incentives should be realigned so that researchers are rewarded for standardizing and sharing data and “consistent ontology.” Also, researchers have to improve interoperability amongst communications and other technologies so that research can benefit from “improved interdisciplinary and international collaboration,” the group said in a report published in the latest edition of Drug Discovery Today. The workshop was held to help focus on what organizers called “human-relevant research.” More than 90 percent of drug candidates entering clinical trials will not be approved by regulators, organizers said. “Without significant intervention, the pipeline responsible for new drug production is predicted to dry up completely within 50 years,” the group said.