A Five-Tiered Structure1
A clinical trials workforce, organized in several dimensions that reflect the broad mission of the CTE, the specific disciplines involved, and the levels of desirable expertise, would consist of several overlapping groups. A construct of five workforce groups was described in a Discussion Paper prepared by Ann Bonham, Chief Scientific Officer, Association of American Medical Colleges; Robert Califf, Duke University Medical Center; Elaine Gallin, Principal, QE Philanthropic Advisors; and Michael Lauer, Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NHLBI), NIH. (See “Developing a Robust Clinical Trials Workforce” in Appendix E.) The co-authors suggested that the structure of the workforce groups necessary to meet the demands of the CTE might resemble a pyramid with five tiers (see Figure 3-1):
• Public—the broadest base of the pyramid consists of patients, families, and citizens who, in the final analysis, have the greatest stake in research results. This tier consists of engaged citizens who support development of the CTE as a national resource or public good and who enroll in trials on a volunteer or basis.
• Community practitioners—health professionals who participate in trials as part of their clinical practices, or at least help enroll their patients as participants. This group will include physicians, nurses, pharmacists, social workers, physical therapists, respiratory therapists, and other health professionals.
• Implementers—individuals who devote specified portions of their professional efforts to serving as principal investigators or collaborating co-investigators, with primary responsibility for implementing clinical trials at a hospital or research site. This workforce group would include physician-scientists, nurse-investigators, clinical 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 conducting
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); Robert Califf, Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Institute, and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center; Elaine Gallin, Principal, QE Philanthropic Advisors; and Michael Lauer, Director, Division of Cardiovascular Sciences, National Heart, Lung, and Blood Institute (NHLBI), NIH. (See Appendix E for the Discussion Paper “Developing a Robust Clinical Trials Workforce.”)