The Evolving Definition of Comparative Effectiveness Research: Lessons for Researchers Planning and Designing a Clinical Development Program

Among the many challenges that must be overcome in successfully developing a novel drug treatment is to understand and prepare evidence that will ultimately be required by regulators and reimbursement authorities. Payers and other stakeholders often state the need for evidence of the comparative effectiveness of new treatments, in some cases arguing that this evidence should be a standard requirement for market access and reimbursement. Comparative effectiveness research (CER) is a method of developing evidence of the clinical and cost effectiveness of true alternative interventions, potentially including long-term data that assess patientcentered outcomes and evidence that a new treatment actually changes clinical practice.