Recommendations for Late Phase Drug Studies in Type 2 Diabetes (July 2014)

The EGD provides guidance for improving the design, conduct, and reporting of late phase (approval and post-approval) drug studies for patients with type 2 diabetes. It includes specific recommendations for the design of prospective clinical studies that reflect the evidence expectations of payers, informed by the perspectives of patients, clinicians, and other decision makers. The recommendations are made in four major areas: population, outcomes, methods, and reporting for patient stakeholders.