GlaxoSmithKline is having trouble recruiting subjects for the FDA-mandated trial of its beleaguered diabetes drug, Avandia. But not necessarily for its health risks.
The pharma giant has closed two sites for lack of participants: Wake Forest University Baptist Medical Center in Winston-Salem, NC, and an unnamed site. Wake Forest "has been struggling for months to find subjects," according to a local press report. Both sites were closed by mutual agreement with independent researcher Population Health Research Institute, which is running the trial for GSK.
About 170 sites worldwide are recruiting for the trial called TIDE, for Thiazolidinedione Intervention in Vitamin D Evaluation. It aims to provide a head-to-head comparison of the cardiovascular risks for Avandia and its competitor, Takeda's Actos.
A subject recruitment double-whammy is currently causing grief for clinical investigators across the board. Researchers from the Tufts Center for the Study of Drug Development find that a rise in the eligibility criteria for acceptable subjects makes it hard to recruit volunteers, while an increase in the complexity of trials--thanks to the growing number of procedures per protocol--makes it hard to keep them. The more complex protocols lengthen trial timelines, discouraging subjects from participating to the end.
Subject recruitment is ripe for automation solutions, and much is being tried. Last summer, for example, Pfizer announced a joint effort with an IT service provider to create a social networking site that would bring together patients and researchers. More recently, the National Cancer Institute launched AccrualNet, an online tool that lets researchers collaborate on subject recruitment.
The FDA is considering halting the trial because Avandia has been linked to an increased risk of heart attacks. GSK disputes the claim.
Duke University Medical Center, however, is still recruiting. The Center has seven subjects enrolled in the trial but admits to difficulty in increasing that figure since word of Avandia's suspected risk began to spread.
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