Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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2 Integrating Community Practice and Clinical Trials
2 Integrating Community Practice and Clinical Trials
Pages 13-26
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From page 13... ...
A CALL FOR DISRUPTIVE INNOVATION IN THE CLINICAL TRIALS ENTERPRISE1 Participation in research is an essential dimension of the social compact among the health care delivery system, health care providers, the public, and the scientific enterprises that serve them. -- Robert Califf, Duke University Medical Center; Gary Filerman, Atlas Health Foundation; Richard Murray, Merck & Co., Inc.; and Michael Rosenblatt, Merck & Co., Inc.
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From page 14... ...
The authors suggested that the transformed CTE may be perceived as consisting of four overlapping "laboratories": Innovation, Traditional Clinical Research, Health Care Delivery, and Community Engagement. Gary Filerman, President, Atlas Health Foundation; Richard Murray, Head of the Global Center for Scientific Affairs, Merck & Co., Inc.; and Michael Rosenblatt (unable to attend workshop)
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From page 15... ...
Integrated health care delivery systems -- along with other research, clinical, and educational entities -- should, in the authors' view, develop and implement research business plans in order to integrate research into TABLE 2-1 The Four "Laboratories" of a Transformed Clinical Trials Enterprise Researchers Laboratory Research Goal Usual Site (Methods) Participants Innovation Develop initial Academic Highly trained, Small evidence about health and with data numbers of treatments science centers management volunteers and biological and acute expertise per trial, but markers and care settings (conduct clinical many trials hypotheses networked trials)
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Adoption of research business plans, under the authority of research directors or chief medical officers, can be expected to speed cultural change in organizations. United States-based clinical research is increasingly noncompetitive.
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In a panel discussion, the session chair, panel presenters, Discussion Paper co-authors, and audience members reacted to and built upon the ideas contained in the Discussion Paper. Participants included session chair, Alastair Wood, Professor of Medicine and Pharmacology, Weill Cornell Medical College, and Partner, Symphony Capital LLC; and panelists Neil Weissman, President of MedStar Health Research Institute, Professor of Medicine at Georgetown University School of Medicine, and Director of the Cardiovascular Core Laboratories at Washington Hospital Center, Washington, DC; and Ihor Rak, Vice President, Global Clinical Development, Neuroscience Therapy Area, AstraZeneca.
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controls 9 hospitals as well as 20 other health care entities. At MedStar, research is integrated into clinical practice, with EHRs used, among other things, to recruit study participants and apply research findings to clinical decisions.
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From page 19... ...
Another speaker cautioned, however, that although a more top-down system might be more susceptible to broad policy changes than the United States' more fragmented approach, China has many systems that do not work in practice and may not be a model to emulate. Some workshop participants discussed the challenge of recruiting clinicians to participate directly in the development and implementation of a clinical trial as an investigator or refer their patients to clinical trials: • There are many challenges associated with use of Medicare funds for research in clinical settings.
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From page 20... ...
Similarly, New York State's Partnership to Advance Clinical electronic Research (PACeR) was described as an example of an industry–academic collaborative estab lished to use EHR data on a continuing, sustainable basis.
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From page 21... ...
21 INTEGRATING COMMUNITY PRACTICE AND CLINICAL TRIALS BOX 2-1a Some Aspects of the Challenge of Persuading Clinicians to Engage in Research Issues Affecting Clinician Incentives to Enroll Patients • ack of demand from patients to participate in research L • nadequate, unsystematic methods of informing clinicians about ongoing or I new research studies and clinical trials • nformation overload; a physician might receive hundreds of emails per day I concerning clinical trials but none coming from an entity or individual the physi cian knows or trusts • f a clinician is not participating in the trial as an investigator, there is concern I over the failure of communication with researchers throughout the lifecycle of a study, including concern by clinicians that they will be unaware of treatments and side effects their patients experience as part of the study • eed for consideration of patients' insurance coverage, or lack thereof, which N could determine whether a research study would make financial sense for a patient under a particular clinician's care • eterogeneous patient mix and a diversity of patient medical needs that may H or may not be solved or improved through care received in a research study Issues Affecting Clinician Willingness to Incorporate Clinical Research into Their Clinical Practice • bsence of cultural awareness and commitment to the principle that physician A patient encounters should generally contribute to the body of scientific evidence • ising productivity pressures and other demands on physicians' time R • rospective income loss for physicians performing procedures that are found P ineffective • ack of reimbursement incentives by Medicare and other third-party payers for L physicians to devote time to clinical research, including clinical trials • atient information in a physician's office is collected both for direct patient care P purposes and to support administrative claims requirements. In many cases, new IT tools and increased staff time will be needed to collect the additional information necessary for a research study Issues Affecting Clinician Use of Medical Evidence in Decision Making • edical schools' separation of research from practice M • ack of clinician knowledge as to the array of clinical trials available and how L participation in a research study might benefit their patients a This box provides a list of suggestions from the workshop audience, themes contained in a summary of the previous IOM workshop on clinical trials and public engagement (IOM, 2012a)
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From page 22... ...
In voluntarily sharing their data in response to a query, health care organizations maintain control of their data behind their firewalls, allowing them to maintain security and 4 This section is based on a keynote address by Richard Platt, Professor and Chair of the Department of Population Medicine at Harvard Medical School and Executive Director of the Harvard Pilgrim Health Care Institute; and on the speaker presentations of Bryan Luce, Senior Vice President for Science Policy, United BioSource Corporation; and Peter Yu, Direc tor of Cancer Research, Palo Alto Medical Foundation. 5 For additional information on the work of the Roundtable, visit http://iom.edu/ Activities/Quality/VSRT.aspx (accessed March 28, 2012)
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From page 23... ...
Steps involved in building a mature CER system might include the following: • Build the research base -- weave CER into the fabric of care, so that clinicians do not have to choose to participate or perform extra steps in its conduct; • Build the business case -- align financial incentives for providers with quality of care; • Address regulatory barriers -- relax or harmonize requirements for informed consent, patient privacy, and other mandated protec tions, when appropriate; • Align quality improvement with CER -- embed both approaches into the routine delivery of care to help produce a learning health sys tem; and • Build demand for scientific evidence from patients, providers, payers, and purchasers -- involve everyone in the transformation. An example of effective collaboration in CER is the Hospital Corporation of America (HCA)
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From page 24... ...
The use of adaptive designs and other pragmatic approaches, such as cluster trial designs and virtual trial designs, was also illustrated by Peter Yu, Director of Cancer Research, Palo Alto Medical Foundation. Traditional clinical trials ignore participants who don't respond to the study drug being tested, Yu explained.
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From page 25... ...
R02159 SOURCE: Yu, 2011. Presentation Figure 2-2 at IOM workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020.
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