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Diabetes Late Phase Drug Studies

Published in July 2014, this 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.

View the complete EGD here.

View the EGD Summary here.