Initial National Priorities for Comparative Effectiveness Research (2009) / Chapter Skim
Currently Skimming:
6 Essential Priorities for a Robust CER Enterprise
6 Essential Priorities for a Robust CER Enterprise
Pages 139-166
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development and support of a highly skilled CER workforce; and (4) vigorous support of research and efforts to translate CER knowledge into everyday clinical practice.
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investing in development, deployment, and support of a highly skilled CER workforce; and (4) supporting a vigorous translational effort to help bring CER knowledge into everyday clinical decision making.
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Scientific Rigor An essential component of CER is the study of representative populations in real-world clinical settings. This demands a wide array of study designs including systematic reviews and meta-analysis, observational analytic methods, modeling, clinical trials, and others.
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health care system has substantial resources -- both public and private -- to contribute to the CER effort. These resources include the private health care organizations that provide care for potential enrollees in CER studies.
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. Yet, even the most sophisticated health care consumers often struggle to find the information that is relevant to their specific health-related questions and particular clinical circumstances (IOM, 2008)
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In breast cancer, the involvement of consumers at all levels of decision making at the DOD Breast Cancer Research Program including vision setting, and peer and programmatic review, has proven valuable to the research process, resulted in an educated and engaged consumer force, and influenced clinical research beyond the DOD research program and beyond breast cancer (IOM, 1997)
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. Other programs include the National Breast Cancer Coalition's Project LEAD Institute, a science education program for breast cancer advocates, and Quality Care Project LEAD; the DOD Breast Cancer Research Program's peer review process, which involves consumer advocates; the FDA's Office of Special Health Initiatives, which trains patient representatives to participate on Advisory Panels (FDA, 2009)
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. Robust Data and INFORMATION Systems As noted earlier and described in greater detail in Chapter 2, CER comprises a broad spectrum of established and emerging research methods including systematic reviews of existing evidence, observational research, and experimental studies such as clinical trials (each described in this section)
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Clinical Trials Fundamental questions of comparative effectiveness often require headto-head comparisons of alternative interventions using randomized assignment to the interventions to be compared. Randomized controlled trials (RCTs)
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Observational studies that link process of care datasets (such as administrative claims data) to outcomes datasets (such as national death indexes)
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. Claims data from large national insurers, electronic health records maintained by large integrated health systems, data collected through practice-based research networks, and patient registry data hold tremendous potential for CER.
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. Researchers can use existing data from larger clinical populations to assess whether the benefits of interventions suggested in smaller clinical trials persist in the broader populations to which treatments are applied in practice.
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Practice-Based Research Networks Practice-based research networks are designed for research on clinical practices and quality improvement activities. These networks generate both primary and specialty care data, often using data gathered prospectively for the purpose of research (in contrast to most existing data from practice, which document routine clinical care and may have important limitations for research purposes)
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. The Cystic Fibrosis Foundation has sponsored a national patient registry for more than 40 years to enable clinicians and researchers to observe trends in the health of people with cystic fibrosis, create clinical care guidelines, design clinical trials to test new therapies, and improve the delivery of care (Cystic Fibrosis Foundation, 2009)
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The system, which will eventually monitor as many as 100 million individuals, will be built from participating electronic health record or claims databases. The Sentinel Initiative system could also be used to study questions of comparative effectiveness.
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The committee also agreed that the federal government should support the development of privacy-enhancing technologies for sharing health information for CER, including methods that minimize or eliminate transfer of protected health information. Distributed research networks, as noted earlier, are designed to keep clinical data within and under the control of the source data systems participating in the network (Brown et al., 2009)
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. They may have medical or other clinical degrees, doctoral degrees in public health specialties, specific training in systematic reviews and clinical trials, and/or post-doctoral or master's-level training.
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4. HHS guidance documents should simplify the HIPAA Privacy Rule's provi sions regarding the use of PHI in activities preparatory to research and harmonize those provisions with the Common Rule, in order to facilitate appropriate IRB and Privacy Board oversight of identification and recruit ment of potential research participants.
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C HS should revise provisions of the HIPAA Privacy Rule that entail heavy H burdens for covered entities and impede research without providing substantive improvements in patient privacy.
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The CER Program should secure long-term, sufficient funding for career development including expanding grants for graduate and postgraduate training opportunities in comparative effectiveness methods, as well as career development grants and mid-career merit awards. Without adequate training and secure, stable financial support, talented investigators are likely to pursue other areas of research.
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The Clinical and Translational Science Consortium is now beginning to expand research networks and emphasize community engagement. But, the health care system will not benefit from CER without the third translational step, and more effort can be made by the Consortium to assess the integration of new findings into practice and their impact on health outcomes.
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2002a. Quantitative impact of including consumers in the scientific review of breast cancer research proposals.
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2005. Challenges in systematic reviews that assess treatment harms.
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2009a. Beyond the HIPAA privacy rule: Enhancing privacy, improving health through research.
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In Implementing Comparative Effectiveness Research: Priorities, Methods, and Impact. Washington, DC: Brookings.
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2009. Strategies to improve comparative effectiveness research methods and data infrastructure.
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Contemporary Clinical Trials 27:580-586. Zerhouni, E
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