Report Finds Problems With FDA Mandated Postapproval Device Studies

As a condition of approval FDA often requires manufacturers of medical devices to perform postapproval studies. Now a General Accounting Office (GAO) audit [PDF] finds that, among other problems, many studies remain unfinished for a great many years.

In addition, digging on its own into the FDA database of postapproval studies, The Gray Sheet, a device industry newsletter, focused on cardiovascular postapproval studies and found some successes but also significant problems.

The GAO audit reported 313 postapproval studies required by the FDA from January 1, 2007 through February 23, 2015. A majority of these studies, 175, or 56%, were for cardiovascular devices. In part the large number of cardiovascular trials was due to an FDA requirement starting in 2008 that companies needed to perform postapproval study on all new ICD leads.

More than two-thirds (69%) of the 313 postapproval studies were prospective cohort studies. Also, two-thirds of the studies relied on data collected by the manufacturer; the remaining third relied on registries.

72% (225 of  313) of the studies were ongoing. Only 20% had been completed and 8% were discontinued. Most of the ongoing studies were “progressing adequately” but 43 studies (19%) were delayed and had been running for more than 3 years. 40 studies “had not progressed as intended” most often because, according to FDA officials, of “limited patient enrollment into the postapproval study.” The completed studies took about 3 years to finish, though the longest took almost 7 years.

Cardiovascular Postapproval Studies

Focusing on the cardiovascular postapproval studies, The Gray Sheet, performing its own analysis, identified 241 cardiovascular postapproval studies from January 1, 2007 through November 4, 2015. More than half (54% were still ongoing, 42% had been completed, and 4% had been stopped, revised, replaced or received an “other” status by the FDA.

For the 102 completed studies the FDA found “that enrollment and follow-up problems, study design or bias issues plagued about one-third of the studies.” 17% of the ongoing studies had their progress categorized as “inadequate” because they had not met enrollment milestones.

The Gray Sheet article quotes Josh Rising, director of health programs at the Pew Charitable Trusts: “Clearly, it’s extremely important that you have enough patients enrolled in the trial to answer the questions that trial’s designed to answer. And from what we’ve seen from the [FDA] postapproval database, there are times when that’s not the case.”




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