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Postapproval Cardio Studies Challenged By Enrollment, Protocol Issues

FDA’s assessments of strengths and weaknesses for eight years’ worth of completed cardiovascular trials show about one-third of studies are challenged by enrollment, protocol or bias issues, according to a graphical analysis by "The Gray Sheet."

More than a third of the cardiovascular postapproval studies completed over the last eight years were challenged with weak follow-up, protocol problems or biases, according to FDA assessments of the studies reviewed by “The Gray Sheet.”

The Government Accountability Office recently issued a report

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