The Impact of Comparative Effectiveness Research on the Clinical Research Enterprise

• Activity Number: 529
• Type: Roundtables
• Date/Time: Wednesday, August 1, 2012 : 12:30 PM to 1:50 PM
• Sponsor: Health Policy Statistics Section
• Author(s): Sheldon Greenfield*+
• Companies: Health Policy Research Center
• Keywords: CER

Abstract

Comparative effectiveness research will lead to major structural changes in the ways clinical research is performed in the US. Three features, in particular, point to the need for new ways of thinking about research: the use of active comparators; the need to incorporate harms into the estimates of effectiveness; and the need to determine the differential effectiveness both in subgroups and in populations usually excluded from trials. Innovations and flexibility in trial design may be necessary. Raising the level of observational studies to approximate randomized trials may be necessary. All of these changes depend on high levels of co-leadership of clinical researchers and statisticians. Finally, data synthesis, deriving from new types and multiple forms of research will challenge the statistical community, so that policy and clinical practice guidelines can be built on solid but more varied evidence.