5
Conclusions and Recommendations

Over the past two decades, policy makers and others have worried about the size and composition of the clinical research workforce, especially because of the changing demographics of the U.S. population and the concomitant implications for biomedical research and health care. Ethnic changes in the population present new challenges for understanding the health of certain populations. In addition, growing segments of the population, such as older women, will present special challenges for healthcare delivery. The increased diversity of the overall workforce, in addition to enhancing its vitality, may encourage greater participation of underrepresented minorities and women in clinical research. The benefits of their increasing representation in the clinical research workforce include greater clinical trial accrual of underrepresented minorities, robust hypothesis generation for research questions related to women and minority populations, and the likelihood that clinical research will more greatly benefit minority communities.

Unfortunately the study scope, as framed by the questions in the study charge, was much broader than the body of available data. The committee found that the first three issues in the study charge could not be answered fully because of the lack of data on the clinical research workforce. This absence of data severely limited the ability of the committee to address questions regarding supply and demand and outcome measures for existing training efforts. Data on the private sector workforce are also not available, similarly limiting the committee’s ability to address the study charge about the needs of the private sector.



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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 5 Conclusions and Recommendations Over the past two decades, policy makers and others have worried about the size and composition of the clinical research workforce, especially because of the changing demographics of the U.S. population and the concomitant implications for biomedical research and health care. Ethnic changes in the population present new challenges for understanding the health of certain populations. In addition, growing segments of the population, such as older women, will present special challenges for healthcare delivery. The increased diversity of the overall workforce, in addition to enhancing its vitality, may encourage greater participation of underrepresented minorities and women in clinical research. The benefits of their increasing representation in the clinical research workforce include greater clinical trial accrual of underrepresented minorities, robust hypothesis generation for research questions related to women and minority populations, and the likelihood that clinical research will more greatly benefit minority communities. Unfortunately the study scope, as framed by the questions in the study charge, was much broader than the body of available data. The committee found that the first three issues in the study charge could not be answered fully because of the lack of data on the clinical research workforce. This absence of data severely limited the ability of the committee to address questions regarding supply and demand and outcome measures for existing training efforts. Data on the private sector workforce are also not available, similarly limiting the committee’s ability to address the study charge about the needs of the private sector.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 The committee found, as others before them, that the single most significant impediment to achieving a better understanding of the problem was the lack of a clear, commonly agreed-upon definition of clinical research. This lack codifies the inability to set standard data definitions and will continue to hobble future attempts to understand and characterize the clinical research workforce. Thus, the collection and analysis of data on the clinical research workforce—and clinical research overall—continues to be a challenge. More data are needed to monitor progress on the clinical research workforce; the use of standard definitions among federal agencies, careful tracking of the subsets of clinical research, and systematic evaluation of existing training efforts would be beneficial. Data standardization would also allow a better review of the composition and outcomes of study sections, which would ensure that women and minority clinical researchers are appropriately represented. Greater numbers of physician-scientists and nurses are needed in the coming years to sustain the clinical research enterprise. Achieving these greater numbers requires examining the training and career paths for clinical research. Leaders in the field have continued to point out that the lack of a defined career path and the lengthy and costly training necessary to conduct clinical research are deterrents to entering the field. Many feel that a major and persistent obstacle to increasing the numbers of clinical researchers is the lack of regard for clinical research as a discipline in academic settings. Students who face numerous challenges to achieving career success—women and minority students face still additional challenges—may find other career paths less daunting. More vigorous recruiting of students at earlier stages is needed to replenish the pipeline to clinical careers and in particular to reach minority populations. Various types of training programs and career tracks foster the development and retention of women and minorities in the clinical research workforce, but more programs are needed for significant improvement. Just as there are not enough data on the clinical workforce to fully understand its supply and demand, there is also not enough evaluation of existing programs to identify which ones most successfully train clinical researchers. Leaders in this field need to expand and evaluate the existing mechanisms for developing new clinical investigators, retaining investigators, and supporting mentors. They should encourage flexibility of career paths in the academic setting, as well as collaboration between basic and clinical researchers.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 RECOMMENDATIONS The study committee found that the following key themes warrant special attention in order to improve the representation of women and minorities in the clinical research workforce: Adequate collection of the appropriate data; Evaluation of the training landscape and mechanisms; The special needs for nursing; The pipeline and the career path for clinical researchers; and The role of professional societies. These themes contain systemic challenges that affect the clinical research enterprise as a whole, as well as specific challenges that should be addressed to improve the strength, character, and diversity of the workforce. The committee offers the following recommendations for major stakeholders (federal government, academic institutions, private sector, and professional societies and associations) with the goal of strengthening and improving the diversity of the clinical research workforce. Data Needs A fundamental difficulty in examining issues surrounding clinical research is the lack of data on the clinical research enterprise as a whole, including data on funding levels, training programs, and who participates in the workforce. It is a challenge to examine ways to sustain and replenish the clinical research workforce when the data needed to understand the state of the clinical research enterprise are not available. Recommendation The National Institutes of Health of the Department of Health and Human Services should initiate a process that will develop the consistent definitions and methodologies needed to classify and report clinical research spending for all federal agencies, with advice from relevant experts and stakeholders (federal sponsors and academic centers). Such a step would allow a better understanding of the training and funding landscape and would enable accurate data collection and analysis of the clinical research workforce.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 The obstacle represented by the lack of accurate data in assessing workforce needs has been noted in every edition of the congressionally mandated report to the National Institutes of Health (NIH) on the biomedical and behavioral research workforce conducted by the National Research Council. This lack stems from inconsistent definitions for classifying expenditures for clinical research across institutes and agencies (IOM, 1994). The 1997 NIH director’s panel report recommended that the percentage of NIH resources devoted to clinical research, as defined by the panel, be monitored and tracked by NIH and that the results be reported annually to the NIH Director’s Advisory Committee (NIH, 1997). A 2002 General Accounting Office report to Congress pointed out that NIH reports of clinical research expenditures do not have precise figures; across institutions and centers the methods that NIH uses to count clinical research dollars are inconsistent, possibly under- or overestimating its actual clinical research expenditures (GAO, 2002). Three different ways of counting clinical research dollars are used by the 20 institutions and centers that fund clinical research, producing very different results. The relevant federal agencies include NIH, Agency for Healthcare Research and Quality (AHRQ), Centers for Disease Control and Prevention (CDC), Department of Veterans Affairs (VA), Department of Defense (DOD), Health Resources and Services Administration (HRSA), and Food and Drug Administration (FDA). Federal agencies should also report on subcategories of clinical research, including preclinical or proof-of-concept human studies, Phases I-IV clinical trials, and effectiveness research (health services, outcomes, prevention, and quality research). Training Landscape and Mechanisms: An Evaluation Clinical research training programs are supported by public (federal government) and private (industry, foundations) sources and are implemented at academic institutions. Continued support is vital to the health of the clinical research workforce, but awareness of and access to the programs are critical if the workforce is to thrive. The effectiveness of programs should be evaluated on a regular basis. Recommendation The Department of Health and Human Services should work with federal clinical research sponsors to identify and describe all federally sponsored training

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 programs (both institutional and individual) for clinical research. The information provided should identify support for each level of training and each discipline across the spectrum of clinical research (defined above). Organized links to these programs should be available on a website, including programs offered at NIH, AHRQ, VA, CDC, and HRSA. This resource should also be open to listing the institutional and individual programs offered by private sponsors for clinical research training. The committee supports the development of the training website offered by NIH1 and encourages NIH to modify and expand this resource to include a focus specifically on clinical research training programs. Academic institutions should document and make publicly accessible the available programs for enhancing the participation of women and minority trainees in clinical research. Opportunities to conduct clinical research should be well publicized at academic institutions. Information on training programs, ongoing studies, community partnerships, and fellowships should be made easily accessible and readily available to trainees. The sponsors of federal, foundation, and industry clinical research training programs should continue to support the existing efforts to train, develop, and sustain the careers of clinical researchers. The pharmaceutical industry is the largest sponsor of clinical trials, and the recruitment of participants, particularly in underrepresented communities, has been a consistent concern. Racial and ethnic diversity of the workforce is an important factor in improving participation in clinical research in these communities. Industry-sponsored fellowships for master’s programs in clinical trial management for undergraduate nurses and students of underrepresented minority students would be one way to better engage minority communities in the clinical research enterprise. 1   NIH at http://www.training.nih.gov/careers/careercenter. Accessed on November 22, 2004.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Recommendation Federal sponsors (NIH, CDC, AHRQ, VA, DOD) should ensure adequate representation of women and minorities in study section review panels that review clinical research. A system that ensures adequate representation of clinical researchers, women, and minorities will help federal research sponsors to maintain an appropriate balance in the review process. This finding was reinforced in the 1997 NIH director’s panel report, which recommended that NIH ensure fair and effective reviews of extramural grant applications. Panels that review clinical research should have a significant proportion of experienced clinical investigators (NIH, 1997). Recommendation Federal agencies and academic institutions should periodically evaluate how well their current training programs are enhancing the racial and ethnic diversity of trainees and they should modify these programs as needed to increase the programs’ effectiveness in clinical research. As the demographics of the student population change, so may training needs. Academic institutions need to assess their training programs on a regular basis so that changes can be made if necessary to ensure success in pursuing clinical research careers. Nursing Professionals The continuing shortfall of nursing professionals is compounded in clinical research by the longer time required for specialized training, and the fewer numbers of nursing faculty involved in clinical research. Recommendation The need for appropriately trained nursing professionals in the clinical research workforce is especially urgent. A significant push is needed to increase the numbers of minorities entering the nursing profession. Additional attention should be paid to the clinical research training of nurse-scientists, nursing students, and nursing faculty at all academic levels.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 The shortage of practicing nurses in the U.S. healthcare delivery system presents challenges to training nurse-scientists. Nursing faculty are pressed to be fully engaged in training nursing students, leaving less time for clinical research. New approaches should be explored to prepare both medical and graduate nursing students in a core interdisciplinary research curriculum to foster interdisciplinary collaboration (e.g., social work, epidemiology). Training initiatives already underway by the National Institute for Nursing Research and the American Academy of Nursing to strengthen nursing school curricula across all levels should be supported and enhanced. Several options for enhancement of training efforts follow. Expansion of fast-track B.S.N.-to-doctoral study to reduce the time to career launch; Expansion of existing alternative career programs (e.g., entry to practice for non-nurses, accelerated B.S.N.-to-master’s programs) for diploma nurses; Summer programs in clinical research for undergraduate and master’s nursing students; Expanded support for HRSA Division of Nursing training grants for specialized doctoral programs in the schools of nursing affiliates of academic medical centers; Institutional pre- and postdoctoral National Research Service Awards in clinical research for nurses that require and support funding for mentorship by a clinical research investigator; Foundation- and industry-supported scholars programs like the John A. Hartford Foundation’s program for Building Academic Geriatric Nursing Capacity and the Pfizer Postdoctoral Fellowships in Nursing Research; K12 fellowship set-asides in clinical research for academic nursing faculty; and Sabbaticals for midcareer nurse-scientists in clinical research. Replenishing the Pipeline: A Flexible Career Path Given the long training period required for clinical research, entry points throughout a clinical research career path, not just at trainee levels, could increase the workforce. Additional efforts are needed to retain scientists in the clinical research workforce.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Recommendation Federal sponsors of clinical research should amplify the existing funding mechanisms and create new ones that allow flexibility in career training, such as second-career programs, reentry mechanisms, and service payback agreements. These programs should be described on the NIH training website. In addition, other entry routes into the clinical research path, including short-term training programs, should be developed. Given the length of time required for training, the clinical research career pathway is fixed, with little latitude for alternative entry points. This situation may filter out well-qualified candidates from other biomedical research career tracks who could enter clinical research in shorter training programs (e.g., one-year programs for medical students). Career paths for women and minorities may not follow the conventional, rigid model because of considerations such as family responsibilities, debt- and risk-aversive trends, and differential debt burdens among different communities. Flexibility in career training is essential if diverse candidates are to thrive in clinical research careers. Recommendation Academic institutions should develop strategies to attract mentors and reward mentorship in clinical research training. A special emphasis should be placed on the women and minorities who carry the greatest burden of mentorship responsibilities for women and minority scientists. Academic institutions should develop flexibility so that the time required for tenure reflects the time course for research, particularly for physician-scientists. The process should also recognize individual differences, academic contribution, and academic service, including mentoring, and where possible should use quantifiable measures of excellence. Academic service (e.g., institutional review boards and other committee service) should count as a significant positive factor in decisions relating to promotion and tenure. Efforts should be made to improve the composition of promotion and tenure committees so that women and minority clinical researchers are represented. Individuals in clinical research pathways should be given the necessary infrastructure to achieve success, including clearly defined benchmarks.

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Opportunities to Address Clinical Research Workforce Diversity Needs for 2010 Clear distinctions should be made between the clinical service role and that of investigators with independent research resources. Credit should be given for volunteer efforts that foster science and math education in the K-12 environment. The Role of Professional Societies Professional societies play a major role in the scientific community, as publishers of journals, sponsors of awards, and representatives of their scientific community. Recommendation Specialty medical and nursing societies should form a new consortium that would assume an enhanced role in fostering a diverse clinical research workforce. The consortium could be based on the Federation of American Societies for Experimental Biology or American Heart Association models and should focus on common development, implementation, and advocacy regarding clinical research training and clinical research priorities (Burroughs Wellcome Fund, 2003). These efforts should include an emphasis on the training, retention, and advancement of women and minorities: Societies should give high priority to developing clinical researchers. Societies should encourage, promote, and foster mentoring of clinical research trainees, paying particular attention to women and minorities. Societies should develop resource sharing and facilitate interaction to foster clinical research training programs, mentors, and trainees. Societies should work toward intersociety initiatives. Clinical research training mechanisms should include identification and creation of a database at the pipeline level whereby potential trainee candidates can be identified and mentors assigned at the earliest possible level. Societies should develop or institute tracking mechanisms to determine training effort outcomes and retention of trainees and mentors.