Rewarding Innovation and Value: What is the Role of Comparative Effectiveness Research

John Doyle, Vice President and Market Access Practice Leader with the Consulting group at Quintiles, explains how comparative effectiveness research will play a major role in the future of drug development.

Recent cases of high-profile failures of products in late-stage pharmaceutical development have clearly highlighted the need for transformational change. Today, new drugs cost as much as $2 billion to develop over eight years or more, with severe attrition at each stage of development. Even those products that gain regulatory approval must often prove their value in health technology assessments (HTAs) or other elements of Comparative Effectiveness Research (CER) by public and private payers.CER is increasingly in the public spotlight as a promising way to help improve the productivity and efficiency of healthcare systems in the United States and abroad.Recent decisions to provide substantial federal funding for CER – $1.1 billion under the 2009 economic stimulus package, and a further $800 million under the 2010 healthcare reform legislation – serve to underline the increasing interest in this approach. In future, CER will change pre-market experimental research design to reflect the requirements of multiple healthcare stakeholders. It will also drive increased investment in post-market observational research on the real-world performance of marketed products.