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White Paper on CTSA Consortium Role in Facilitating Comparative Effectiveness Research

Background 
Appreciating the need to better translate biomedical research into improved clinical care and health, the NIH Roadmap was initiated in 2003 to focus on this by strengthening NIH’s central role in clinical research and clinical research training. As part of the needed re-engineering, in 2006 NIH began the CTSA program. At this writing (Summer 2009), there are 39 CTSAs at leading universities across the United States, each having a clinical research graduate program and extensive resources for promoting clinical and translational research. Each of these, and the CTSA Consortium as a whole, are committed to transforming clinical and translational research to maximize impact on health. 
 
The CTSAs bring to this challenge an array of capacities, extensive research infrastructure, formal training and career development programs, community engagement of the public and of clinical practice communities, and informatics related to research and clinical practice. Various CTSAs have different areas of emphasis, including along the spectrum of translational research from bench to patient bedside (the first translational step, “T1”), from the bedside to general use in clinical practice (“T2”), and from clinical practice to public benefit and policy (“T3”). This broad array of activities has allowed the national consortium to be responsive to needs all along this path of translation of biomedical research into practice and public benefit. Although the activities of CER can be seen as primarily involving T2 and T3 research, they also can be seen as focusing on the optimal translation of T1 research into effective treatment, and thus the very epitome of work in which CTSAs should be deeply involved. This appreciation was reinforced by CER’s selection as a key Strategic Goal focus of the CTSA Consortium. 
 
In this context, the CER Strategic Goal of the CTSA Consortium is to promote the translation of the results of clinical and translational research into practice and public policy. In service of this, in two sections below, we review the span of CER resources across the CTSA Consortium and propose potential roles for CTSAs in supporting CER. 
 
As a point of reference for this White Paper, below are two important definitions of CER from reports released at the end of June 2009, from the IOM and from the FCC-CER: 
 
 
 
Definition from the IOM Report on Priorities for CER 
The generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist patients, clinicians, purchasers, and policy makers, and the public to make informed decisions that will improve healthcare at both the individual and population levels.