Article preview reprinted from "The Gray Sheet" - January 18, 2010
In the wake of recent reviews criticizing the quality of pre-market cardiac device trials, FDA, industry, clinicians and others are debating what reforms are necessary to PMA study standards. Read more...
Article preview reprinted from "The Gray Sheet" - January 18, 2010
Research Backlash: Does FDA Have A PMA Problem?
In the wake of recent reviews criticizing the quality of pre-market cardiac device trials, FDA, industry, clinicians and others are debating what reforms are necessary to PMA study standards.
The two reviews, one published in the Journal of the American Medical Association and the other in the American Journal of Therapeutics, analyzed about eight years of clinical data for PMA-approved cardiovascular devices and concluded that data supporting these approved products was sub par or, at least, inconsistent (The Gray Sheet' Jan. 4, 2010).
In response, device firms defended the pre-market approval process, as acting FDA device chief Jeffrey Shuren promised tougher standards ahead for pre-market clinical trials.
The agency says the AJT study, co-authored by FDA staff and Harvard researchers, is part of a broader CDRH effort to evaluate its PMA program.
"The findings are applicable to the whole center for devices," Bram Zuckerman, CDRH cardiovascular devices review division director and an author on the AJT study, said in an interview. So, all manufacturers should take note, he said.
Later this year, the agency plans to release draft guidance on clinical trial design, as well as draft guidance on gender-related trial design issues. FDA says it also will revise internal standard operating procedures for device review staff.
The clinical trials draft guidance will likely expand on recommendations in the AJT study for more clearly defined safety and effectiveness endpoints with concrete evaluation timeframes, and for better patient accounting practices.
FDA's other ongoing trial improvement initiatives include the public-private Clinical Trials Transformation Initiative, launched in 2007, and FDA-industry efforts in the pediatric device trial development arena, Zuckerman noted (The Gray Sheet' May 19, 2008).
"The agency is diligently going to follow up on the recommendations made in the [AJT] paper, as well as other internal recommendations that have been recently brought forth as a result of our own independent internal review," he said.
FDA says it is currently conducting a larger study of clinical trials submitted in support of PMAs for all device types.
According to William Maisel, M.D., Beth Israel Deaconness Medical Center, another author on the AJT study, the suggested improvements should not be difficult to implement and could benefit device makers.
"We think the quality of scientific data can be improved without additional time, necessarily, and without substantial additional cost," Maisel said.
"You could potentially study the same number of patients for the same length of time, but just collect data better, ask the right questions and meet with the FDA prior to starting your study so you can define your effectiveness and safety endpoints" before starting a trial, he said.
When faced with suboptimal PMA data, FDA staff must work harder with industry to fully understand the data they are presented with, Zuckerman noted, and in some cases request additional information before making an approval decision.
"In the end, everyone suffers by that," he said.
- Jessica Bylander
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