Complex issue of CER in biopharmaceutical development explored

Oct 22 2009

In a new report released today, John Doyle, Vice President and Practice Leader for Quintiles Consulting, and an expert on pharmaceutical market access, explores the complex issue of comparative effectiveness research (CER) and its strategic importance in successful and efficient biopharmaceutical development. The report addresses the potential for a universally accepted pharmaceutical valuation system based on a standard set of CER principles.

Comparative Effectiveness Research is an approach in which pharmaceutical products are evaluated in a true-to-life setting against the current standard of care. CER includes an appraisal of a therapy’s safety and effectiveness, often measured in clinical, economic, and humanistic dimensions.

In the report, titled, “Rewarding Innovation and Value: What is the Role of Comparative Effectiveness Research?” Dr. Doyle discusses the concept of broadening metrics and study designs to “accurately and fairly” appraise the value of pharmaceutical innovation rather than focusing on costs. In addition, he issues a challenge to pharmaceutical companies regarding their role in driving CER methodology, urging biopharma companies to engage in discussions to assist in developing guidelines for the proper design and application of CER.

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