How FDA Guidance for Developing Diabetes Drugs is Affecting Trial Design


In 2008, the US Food and Drug Administration (FDA) issued guidance which means that all antidiabetic drugs to be licensed in the future require thorough assessment of cardiovascular safety.

In Current Cardiology Reports, we review the circumstances from which the FDA guidance arose, and examine the differences in clinical trials registered on ClinicalTrials.gov in the 36 months before and after the guidance was issued.

We found a doubling in the number of cardiovascular outcome trials registered and a six-fold increase in the median number of patients included in cardiovascular outcome trials in the latter 36 months.

As the size and duration of follow-up for these trials increases, the clinical trials industry is going to have to adapt. As a result, in this review we also provide a summary of the current attempts to streamline trial design and management to meet these new challenges.