Article preview from Start-Up - November, 2011
FDA released two draft guidance documents and announced a new pilot program last week in an attempt to make it easier for companies to begin clinical trials in the US. The first draft guidance, issued November 10, focuses on streamlining requirements to initiate and make changes to very-early-stage clinical studies, including first-in-human trials, which are now often conducted overseas for breakthrough technologies. As part of that effort, FDA is also launching a pilot program where selected sponsors will seek to initiate early feasibility trials, including first-in-human studies, by applying the draft guidance recommendations.
Article preview from Start-Up - November, 2011
The second draft guidance focuses more generally on the investigational device exemption process, with the goal to offer flexibility in addressing outstanding issues to allow clinical investigations to begin without unnecessary delays. Comments on both draft guidances are due February 8, 2012.
Industry representatives and physicians have complained that too many barriers stand in the way of initiating studies in the U.S., and that FDA’s IDE review process is too burdensome. FDA says it wants to strike a balance by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected.
The issue has been particularly significant in driving very-early-stage studies, which are crucial components of the country’s R&D infrastructure, overseas, industry and researchers argue. Some estimates suggest that upwards of 95% of early clinical device evaluations are conducted outside the US.
FDA says it wants to strike a balance with the guidance documents by allowing firms to begin trials earlier through adaptive study designs, while ensuring that patients are adequately protected. “Approaches to regulation that facilitate early clinical experience with investigational medical devices can result in safe and effective devices that reach patients sooner and create incentives to innovate in the United States,” said CDRH Director Jeffrey Shuren in a November 10 statement.
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