FDA Policy Change Would Make It Easier To Start Pivotal Trials

Article preview from "The Gray Sheet"- October 31, 2011

FDA is changing the way it vets clinical trial plans to allow firms to start pivotal trials earlier while still ensuring that the study data ultimately supports a pre-market application.

FDA Policy Change Would Make It Easier To Start Pivotal Trials

Article preview from "The Gray Sheet"- October 31, 2011

The agency gave a glimpse into its upcoming draft guidance on clinical trial investigational device exemptions last week at the Regulatory Affairs Professionals Society annual meeting in Indianapolis.

FDA admits it faces a conundrum: Setting the bar for approving an IDE study plan too high could delay the introduction of innovative new products. But setting the bar too low could allow companies to move forward with clinical trials that ultimately cannot support an FDA approval.

The new draft guidance – expected out within the next few months – is meant to strike a balance between speed and prudence.

“We want to try to encourage early study design and development and initiation,” Christy Foreman, director of FDA’s Office of Device Evaluation, said at the RAPS meeting.

About two years ago, FDA implemented a policy of only approving IDEs for pivotal clinical trials that the agency believed would support a marketing application. Previously, the agency approved IDEs even if it had doubts about whether the study would produce the data necessary to support a PMA.

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