Adjudication Strategies in Cardiovascular Outcomes Research

Date: 30 Oct. 2013  |  Topic: experience
Meha Ballard, RN

Meha Ballard, RN

Senior Manager, Pharmacovigilance
PPD

William Crafford

William Crafford Jr., M.D.

Medical Director
PPD

The amount of data required to demonstrate cardiovascular (CV) safety in diabetes clinical trials has increased tremendously since FDA guideline changes were implemented in December 2008. In this paper, PPD experts discuss how to successfully address the challenges posted by the FDA CV safety guidelines through carefully planned and comprehensive endpoint adjudication procedures that will ensure the quality and reliability of data prior to trial initiation. 


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