Investment in comparative effectiveness research (CER) -- including $1.1 billion of new federal funding appropriated in the American Reinvestment and Recovery Act and the creation of the Patient-Centered Outcomes Research Institute -- has sparked interest from a range of stakeholders on how this research will be structured, disseminated, and used. At the core of this debate is the important question of how CER investments will shape incentives for bringing new therapies to market -- the effect on pharmaceutical innovation investment decisions. It is critical that policy makers and the public understand the links between public policies in this area and product development decisions that may impact development and access to new pharmaceutical technology. To address this issue, researchers convened a roundtable of public and private payers, clinicians, and academic researchers. Researchers then integrated that expert insight into their own market research and constructed a framework of topics and questions that policymakers and stakeholders must consider in anticipating the full impact of CER on innovation:

• CER Generation: How does the way in which CER is generated affect the knowledge and attitudes of payers, providers, and patients toward using the information in decision-making?
• CER Application: What is the role of CER findings on public and private payer coverage decisions? What types of CER do physicians currently use when making treatment choices? Is the availability of CER in key therapeutic areas associated with further specificity and differentiation in the type of recommendations presented in clinical guidelines?
• Pharmaceutical Development and Societal Health Outcomes: How does the integration of CER into clinical practice affect the types and timing of product development investment decisions made in the development and commercialization of medical products? Do different policy constructs shaping clinical practice lead to different product investment decisions?

Potential Comparative Effectiveness Research Impact on Innovation

• Untangling the potential impact of CER on innovation must be multi-dimensional and will require better understanding of the type of CER that will be developed and how it will be used by an array of decision-makers.
• When policymakers change how government evaluates medical products, they will change the kinds of studies that are developed to support registration and marketing. This framework is meant to help guide policy and commercial decision-making to achieve an appropriate balance.
• A CER framework should encourage innovation as well as improve health outcomes for patients. To ensure those goals, we need to address how CER will be generated, disseminated, and integrated by key healthcare stakeholders.