Envisioning a Transformed Clinical Trials Enterprise in the United States Establishing an Agenda for 2020: Workshop Summary (2012) / Chapter Skim
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Appendix E: Discussion Paper: Developing a Robust Clinical Trials Workforce
Appendix E: Discussion Paper: Developing a Robust Clinical Trials Workforce
Pages 161-182
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This discussion paper was presented in draft form at the Forum's November 2011 workshop, Envisioning a Transformed Clinical Trials Enterprise in the United States: Establishing an Agenda for 2020, and finalized by the authors following the workshop.
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Finally, the new field of com munity engagement requires special skills that blend traditional clinical trials knowledge with social and organizational constructs. The challenge is considerable, because most roles in clinical research at their core involve human experimentation and require specific expertise in a clinical or scientific discipline.
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Nor is the OAT experience unique or even unusual; the difficulty experi enced across fields by American clinical trialists seeking to enroll patients and engage practitioners is well documented. Clinical Research: A Public Good?
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In our view, the largest segment of the clinical trials workforce comprises all individuals -- the general public -- including the diverse communities and neighborhoods across the United States. Individuals should not only participate in trials as volunteers but should be viewed as partners in the clinical trials enterprise with the ability to mobilize their friends, families, and communities to drive change.
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to be done at a much lower cost by reducing or eliminating redundant data collection, but unless knowledge generation is embraced as a fundamen tal component of practice, the gap between existing evidence and practice needs will remain cavernous. The ideal clinical trials workforce will be orders of magnitude larger than its present size, because it will include nearly all of the 90 percent of clinicians who currently are not part of the clinical trials enterprise.
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, in collaboration with the CTSA [Clinical and Translational Science Awards] Education and Career Development Key Function Committee, formed the Education Core Competency Work Group to define the training standards for core competencies in clinical and translational research.
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This group is primarily responsible for implementing clinical trials at the level of a hospital or research site. Implementers will include physician-scientists, nurse-investigators, operations specialists, data managers, computer specialists, pharmacists, social service personnel, and others vital to the implementation of clinical trials.
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. There is a critical need to expand this part of the clinical trials workforce and improve its core competencies.
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This relatively small yet substantial cadre of clinical investigators, biostatisti cians, epidemiologists, and health services researchers is vital to advanc ing clinical trials methods. These experts will be located within AHSSs, government, research institutes, and some large industry groups with capacity to fund protected time for research.
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, will increase correspondingly, reaching 16 percent of the population by 2020 and nearly 20 percent of the total population by 2025. According to the Population Reference Bureau, more than 20 percent of this 65-plus cohort will be grouped with the "oldest old" -- persons ages 85 and older.
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One of the plan's five goals is to advance scientific knowledge and innovation relating to health dispari ties through data collection and promoting patient-centered outcomes research. A second major goal focuses on improvements to workforce development, including through a new pipeline program for recruiting undergraduates from underserved communities for public health and biomedical sciences careers, expand ing and improving health care interpreting and translation, and sup porting more training of community health workers, such as promotoras.
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-- aspects that could greatly complicate trial design and analysis. In order to gauge the impact of health disparities on different populations and assess which interven tions are truly most effective for diverse communities, the national CTE will need to engage in multisite trials covering broad geographic ranges and including many provider organizations.
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Implications for a Clinical Trials Workforce A diverse, inclusive workforce helps to build trust among diverse research participants through outreach and engagement with communities. A diverse workforce can constitute the foundation for increased participation in research by underrepresented groups, and can even change the nature of the questions addressed by clinical trials.
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2012. The Clinical Trials Enterprise in the United States: A Call for Disruptive Innovation.
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2011. A population-based assessment of specialty physician involvement in cancer clinical trials.
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• ropose study designs for addressing a clinical or P translational research question. • ssess the strengths and weaknesses of possible study A designs for a given clinical or translational research question.
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• mplement quality-assurance systems with control I procedures for data intake, management, and monitoring for different study designs. • ssess data sources and data quality to answer specific A clinical or translational research questions.
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• ollaborate with biostatisticians in the design, conduct, C and analyses of clinical and translational research. • valuate computer output containing the results of E statistical procedures and graphics.
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• pply the rules and professional standards that govern A data collection, sharing, and protection throughout all phases of clinical and translational research. • pply elements of voluntary informed consent, of A fostering understanding of information about clinical research, and for avoiding undue influence or coercion, and taking into consideration the decision-making capacity of participants.
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• ranslate clinical and translational research findings T into national health strategies or guidelines for use by the general public. • xplain the utility and mechanism of commercialization E for clinical and translational research findings, the patent process, and technology transfer.
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• ppraise the role of community engagement as a A strategy for identifying community health issues, translating health research to communities, and reducing health disparities. • ummarize the principles and practices of the spectrum S of community-engaged research.
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182 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE Academicians Doing Research on Clinical Trial Methods and Policies Clinical Trial Investigators Clinical Trial Implementers All Health Care Providers All Individuals FIGURE 1 Workforce for a transformed clinical trials enterprise. R02159 Figures 3-1 and E-1 vector, editable
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