Impact of FDA guidance for developing diabetes drugs on trial design: from policy to practice

Curr Cardiol Rep. 2012 Feb;14(1):59-69. doi: 10.1007/s11886-011-0229-7.


In 2008, the US Food and Drug Administration (FDA) issued guidance requiring robust assessment of cardiovascular safety for all antidiabetic drugs to be licensed in the future. Here, we review the circumstances giving rise to the FDA guidance and describe the characteristics of clinical trials registered on in the 36 months before and after the guidance was issued. We noted a doubling in the number of cardiovascular outcome trials registered and a sixfold 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 will need to adapt. The present review summarizes current attempts to streamline trial design and management to meet the requirements efficiently while adhering to the highest scientific standards.

Publication types

  • Review

MeSH terms

  • Cardiovascular Diseases / chemically induced
  • Cardiovascular Diseases / drug therapy*
  • Cardiovascular Diseases / epidemiology
  • Clinical Trials as Topic*
  • Diabetes Mellitus / drug therapy*
  • Diabetes Mellitus / epidemiology
  • Diabetic Angiopathies / chemically induced
  • Diabetic Angiopathies / drug therapy*
  • Diabetic Angiopathies / epidemiology
  • Female
  • Guideline Adherence
  • Health Policy
  • Humans
  • Hypoglycemic Agents / adverse effects
  • Hypoglycemic Agents / therapeutic use*
  • Male
  • Practice Guidelines as Topic
  • Research Design*
  • United States / epidemiology
  • United States Food and Drug Administration


  • Hypoglycemic Agents