Interagency Communication On Trial Designs Urged At FDA/NIH Meeting

Article preview from "The Gray Sheet"- June 7, 2010

FDA and National Institutes of Health staff should compare notes earlier to ensure that research conducted under the NIH umbrella also meets the needs of FDA regulators, speakers said at a June 2 public meeting sponsored by the agencies.

Interagency Communication On Trial Designs Urged At FDA/NIH Meeting

Article preview from "The Gray Sheet"- June 7, 2010

FDA and National Institutes of Health staff should compare notes earlier to ensure that research conducted under the NIH umbrella also meets the needs of FDA regulators, speakers said at a June 2 public meeting sponsored by the agencies.

FDA and NIH held the meeting to gather input as they prepare an agenda for the agencies' new joint leadership council.

The council, established in February, is part of a broader effort between FDA and NIH to speed the translation of biomedical research into new medical therapies and to integrate the latest scientific knowledge into the FDA review process.

"Research is currently translated much too slowly," affirmed Paul Gurbel, M.D., of Sinai Hospital, representing the American Heart Association.

"The most important step ... is the creation of a seamless process of communication between NIH and FDA, specifically to identify gaps in science," Gurbel said.

This would help harmonize the approaches used in randomized clinical trials and reduce regulatory barriers when companies attempt to bring new products to market.

"A major obstacle to the success of novel agents or indications developed by NIH-funded research is the absence of investigator expertise in [investigational device exemption or investigational new drug] processes," Gurbel said. "As a result, large trials funded by NIH may be delayed by unexpected FDA regulatory concerns."

Gurbel was one of 17 presenters at the meeting, held at FDA headquarters in Silver Spring, Md.

FDA and NIH should communicate earlier, he said.

"For example, after the council has approved a proposed trial for review, an FDA representative could be automatically brought into the discussion to discuss IND and IDE issues."

And the most important area for better communication and harmonization is clinical trial design, he emphasized.

FDA's evolving thoughts on clinical trial designs should be communicated to NIH reviewers and investigators, Gurbel concluded.

Jamie Lamson, associate director of public policy and advocacy at the COPD Foundation, also hopes the council will provide an "active, two-way exchange of information with FDA and NIH."

"Moving forward, a strong, consistent collaboration in data collection and review will result in a broad, robust set of evidence that meets the needs of regulators and changes the way science is viewed on both ends," said Lamson, whose group supports research and enhanced therapies for people with chronic obstructive pulmonary disease.

Request For Clear Pathway For Diagnostics

Speakers also urged the leadership council to define, once and for all, a single regulatory oversight system for all diagnostic tests, whether developed in a lab or by a commercial vendor.

"The regulatory pathway is at best muddled," said Ellen Sigal, Ph.D., founder of the nonprofit Friends of Cancer Research.

Sigal said FDA and NIH need to clarify the regulatory pathway for companion diagnostics, in particular, which help assess the best candidates for drug therapy based on a patient's genetic or genomic make-up.

Attorney Paul Radensky, representing the Coalition for 21 Century Medicine, also urged FDA and NIH to work together to develop guidelines for validating advanced diagnostic tests.

"NIH conducts a lot of research in this area and can be a very good laboratory for identifying what are appropriate standards for validation," Radensky said. "That can then be shared with FDA [and] can form the basis of guidance."

Other presenters at the FDA/NIH meeting highlighted ongoing projects the council could contribute to, as well as other issues the council should address.

As part of the FDA science initiative, FDA and NIH have also requested applications for proposals on ways to advance regulatory science. The group has received 58 applications to date and is "putting together the review for that as we speak," NIH's Hudson said. Related grants will be awarded this fall.

The FDA/NIH council will be co-chaired by FDA Commissioner Margaret Hamburg and NIH Director Francis Collins, and also includes six additional members from each agency.

The council hopes to hold its first formal meeting later in June, NIH Chief of Staff Kathy Hudson said at the stakeholder meeting.

- Jessica Bylander

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