Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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1 Introduction
1 Introduction
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The CTE includes the processes, institutions, and individuals that eventually apply clinical trial findings to patient care. (See the glossary of key terms in Appendix K for additional definitions.)
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, which, like RCTs, examine the relative success of specific drugs or other interventions and provide additional opportunities to better understand existing therapies. In the United States, clinical trials are conducted, funded, and regulated by several important components of the health care sector.
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• tudy participants (patients and healthy volunteers who decide to participate S in a clinical trial) Primary Consumers of Clinical Trial Results • cientists and researchers S • ealth care delivery system H • ealth care purchasers and payers (e.g., Medicare, Blue Cross and Blue Shield, H individual patients)
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Promising innovations include adaptive designs in which a prespecified plan defines prescribed changes to study end points and other criteria over the course of a study based on collected data and the treatment responses of prior participants; pragmatic trials that investigate an intervention's effectiveness in real-world conditions, rather than efficacy only (this approach may involve fewer inclusion and exclusion criteria for individuals to participate in the trial, as well as longer study timelines that seek to evaluate patient-centered outcome measures or end points) ; and virtual or web-based clinical trials that involve the online registration of study participants to overcome enrollment challenges posed by the current geographic distribution of clinical trial sites (IOM, 2012a)
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• ocietal or individual biases toward providing potentially promising treatments S to all individuals who might benefit from them, as opposed to randomizing individuals to receive or not receive the treatment in an RCT • nconsistent adoption of clinical trial results by health care providers, payers, I and patients in making decisions regarding individual patient care a This box provides a nonexhaustive list of some of the challenges to the CTE noted in the Discussion Papers contained in Appendixes D-G and suggested by individual workshop participants. LINKING THE TRANSFORMATION OF THE CLINICAL TRIALS ENTERPRISE AND IMPROVING QUALITY OF CARE The scientific process is actually part of the very basic fiber of what we do as clinicians in seeing a patient.
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Features of a learning health system are also likely to include a focus on comparative effectiveness research (CER) , to help patients and clinicians choose a treatment approach that is likely to work best for the specific patient; this research frontier, too, has been the subject of a continuing succession of IOM reports (IOM, 2009, 2011b)
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. A recent presidential commission likewise advocated using EHRs to build data sets on treatment results, thereby facilitating clinical trials and other medical research -- a use of health information technology (IT)
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The titles of the four plenary workshop sessions and the corresponding Discussion Papers were as follows: • Session I: "Framing the Need for Change: Envisioning a Clinical Trials Enterprise in the Health Care System of 2020"5 • Session II: "Developing a Robust Clinical Trials Workforce"6 • Session III: "Aligning Cultural and Financial Incentives"7 5 Corresponding Discussion Paper "The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation" (see Appendix D)
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. I think if we are really talking about transforming an 8 Corresponding Discussion Paper "Developing a Clinical Trials Infrastructure" (see Appendix G)
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; • enhancing interest in, and understanding of, the importance of clinical trials -- from building the workforce to conduct trials, to engaging the nation to support and take part in trials (Chapter 3) ; • creating a new business model for clinical trials by incorporating technologic advances and increased efficiencies and by appropri ately framing regulatory issues (Chapter 4)
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11 INTRODUCTION Sidebar: Clinical Trials and Clinical Research in the Context of This Workshop Although the focus of the workshop was on clinical trials to support drug devel opment and evaluation, specifically RCTs, there was also significant discussion of the broader topic of clinical research (e.g., the use of observational data for CER and evaluations of the safety and quality of medical care)
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