Redesigning the Clinical Effectiveness Research Paradigm Innovation and Practice-Based Approaches: Workshop Summary (2010) / Chapter Skim
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7 Organizing the Research Community for Change
7 Organizing the Research Community for Change
Pages 363-378
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From page 363... ...
Comments throughout the workshop also highlighted system fragmentation and misaligned incentives that limit capacity to conduct timely research that addresses practical clinical questions. Cross-discipline and cross-sector work was emphasized as essential to shaping and supporting the development of an efficient and robust clinical effectiveness research enterprise.
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From page 364... ...
Common themes and follow-up opportunities for the Roundtable, noted throughout the discussion are also summarized here.1 INCREASING KNOWLEDGE FROM PRACTICE-BASED RESEARCH The multifaceted, practice-oriented approach to clinical effectiveness research discussed at the workshop complements and blends with traditional trial-oriented clinical research and may be represented as a continuum in which evidence is continuously produced by a blend of experimental studies with patient assignment (clinical trials) ; modeling, statistical, and observational studies without patient assignment; and monitored clinical experience (see Figure 7-1)
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From page 365... ...
Krensky, National Institutes of Health; Garry Neil, Johnson & Johnson; John Niederhuber, National Cancer Institute; Lewis Sandy, United Health Care The five panelists opened the final workshop session by discussing some key needs and opportunities for the future of clinical effectiveness research.
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From page 366... ...
Clarify the Mission and Focus of Clinical Effectiveness Research The fundamental mission of research is to help patients, yet there has been a detectable shift away from this basic tenet, as research organizations focus more on economics and less on impacting health outcomes. The identification of priority areas for research presents the opportunity to force greater focus on key issues, and a clear prioritization approach to identify issues with the greatest impact on the nation's health and healthcare system would help decision makers to allocate limited resources more effectively (e.g., where limited evidence exists and there is high variability in practice; high costs and growth potential; or large populations are affected)
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From page 367... ...
Develop a Research Paradigm That Strengthens Research Capacity The goal of clinical effectiveness research is to provide information on the effects of interventions on treatment outcomes in routine care. From hybrid studies and the mining of large databases to practices such as cluster randomization, pragmatic trials, and practice-based investigations and new study designs (e.g., equipoise stratified randomized designs and adaptive treatment studies)
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From page 368... ...
provide information about efficacy, and hybrid approaches that combine the best attributes of RCTs with complementary methodology have been employed to develop more information on effectiveness. The recently completed National Institute of Mental Healthsponsored comparative effectiveness trials of antipsychotic medications in patients with schizophrenia (the CATIE trials)
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However, specialty society registries offer opportunities for immediate progress. These clinical data resources have been used to conduct postmarket studies as well as large-scale trials.
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Collaboration will be needed in efforts to aggregate data from diverse sources, construct measures consistently, and better use existing data resources. Other efforts to move to more integrated data capabilities, including the addition of clinical data to administrative databases will expand research capacity.
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• Counter inefficiencies in timeliness, costs, and volume. Much of cur rent clinical effectiveness research has inherent limits and inefficien cies related to time, cost, and volume.
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• Encourage innovation in clinical effectiveness research conduct. The kinds of "safe harbor" opportunities that exist in various fields for developing and testing innovative methodologies for addressing complex problems are rarely found in clinical research.
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• Foster the transformational research potential of information tech nology. Broad application and linkage of electronic health records holds the potential to foster movement toward real-time clinical effectiveness research that can generate vastly enhanced insights into the performance of interventions, caregivers, institutions, and systems -- and how they vary by patient needs and circumstances.
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Clinical Effectiveness Research • Methodologies. How do various research approaches best align to different study circumstances -- e.g., nature of the condition, the type of intervention, the existing body of evidence?
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Should a venue be established for periodic convening of primary care and specialty physician groups to explore clinical effectiveness research priorities, progress in practice-based research, opportunities to engage in registry-related research, and improved approaches to clinical guideline development and application? • Academic health center engagement.
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Clinical Data • Secondary use of clinical data. Successful use of clinical data as a reliable resource for clinical effectiveness evidence development requires the development of standards and approaches that assure the quality of the work.
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From page 377... ...
Because shortfalls in coordination and communication impinge on the funding, effectiveness, and efficiency of the clinical research process -- not to mention its progress as a key element of a learning healthcare system -- the notion of working productively together is vital for both patients and the healthcare community. Better coordination, collaboration, public–private partnerships, and priority setting are compelling priorities, and the attention and awareness generated in the course of this meeting are important to the Roundtable's focus on redesigning the clinical effectiveness research paradigm.
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