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.”
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."