Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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3 Improving Public Participation in Clinical Trials
3 Improving Public Participation in Clinical Trials
Pages 27-42
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From page 27... ...
The participation of both clinicians and patients and healthy volunteers has been considered in these discussions. The workshop's second session, "Developing a Robust Clinical Trials Workforce," and the following key note session explored ways to identify and meet workforce needs and to enhance public engagement in the CTE.
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This workforce group would include physician-scientists, nurse-investigators, clin ical pharmacologists, research-oriented social workers, operations specialists, data managers, computer specialists, clinical research coordinators, and research site managers. • Investigators -- leaders and designers of clinical trials and scientific experts who develop tools and innovative approaches for conduct 1 This section is based on the presentations and Discussion Paper by Ann Bonham, Chief Scientific Officer, Association of American Medical Colleges (unable to attend workshop)
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Developing a Robust Clinical Trials Workforce. Discus R02159 sion Paper, Institute of Medicine.
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SOURCE: Bonham et al., 2012. Developing a Robust Clinical Trials Workforce.
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The co-authors noted that, even if demographic parity is not achieved in all areas of the workforce, the CTE could benefit if researchers are skilled in engaging the community in clinical trials and able to accommodate demographic trends in designing, implementing, and analyzing clinical trials. OPPORTUNITIES TO CREATE A SUSTAINABLE WORKFORCE FOR THE CLINICAL TRIALS ENTERPRISE 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.
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From page 32... ...
Incorporating clinical research into the high school curriculum could lead to students' assisting their parents with participation in clinical research studies, including clinical trials. Several workshop participants noted that, given the pace of change in both medical science and health care delivery, the ability to be an "informed consumer" is essential to maintaining health and maximizing benefit from the health care system.
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From page 33... ...
According to some participants, the culture of research in North American medical schools appears to be diminishing. Part of physicians' reluctance to participate in, or apply findings from, clinical trials may stem from attitudes rooted in the Flexner reforms of medical education dating back a century ago, noted Califf.
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Partly to promote the field and imbue it with the advantages of a recognized profession, efforts to develop an accreditation program for these professionals have begun at the University of Pennsylvania, and a Society of Clinical Research Asso ciates has been created. With expertise in both management and clinical sciences, clinical research coordinators conceivably could be educated through master's degree programs jointly developed by medical and business schools.
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This group of clinical investigators would consist of biostatisticians, epidemiologists, and health services researchers tasked with advancing and improving upon clinical trial methodologies. The workforce group would reside primarily in AHSSs, government, research institutes, and some larger industry groups that could provide protected time for research.
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From page 36... ...
Studies are divided roughly in half between natural history studies of disease patho genesis in patients with rare diseases and clinical trials. NIH intramural clinical research benefits from the agency's adherences to seven "principles and processes" that it provides researchers: clinical informatics, data management, and protocol tracking; biostatistics support; quality assurance and quality improvement; protocol review; human resources and physical plant; training and education; and research participants, or research partners, as the term used at the Clinical Center.
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Making them more widely available also helps the Clinical Center fulfill its mandate to open its doors to extramural investigators.
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To generate a larger pool of protocol navigators for intramural and extramural research support, the Clinical Center is developing a oneyear training program intended as an alternative career path for research nurses, scientific writers, and IRB professionals to become versed in pro tocol navigation. The Clinical Center's new vision statement reads: "The role of the NIH Clinical Center should be to serve as a state-of-the-art national resource, with resources optimally managed to enable both internal and external investigator use" (NIH, Scientific Management Review Board, 2010)
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2011. Presentation at IOM workshop on Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020.
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Networks might revolve around academic health and science center hubs and include community practi tioners, whose patients could participate in trials through visits to their usual practitioner's office rather than to a distant research site. Engaging patients in the development of novel clinical trial designs and the determination of clinical end points may help in raising enrollment rates.
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From page 41... ...
To illustrate, mere education about clinical research and randomization may not suffice to increase recruitment rates, especially in the face of the heavy burden of participation. An evaluation of the "Get Randomised" media campaign in Scotland revealed that, although the campaign increased public awareness about clinical research, it did not increase the willing ness of individuals to participate in clinical studies (Mackenzie et al., 2010)
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