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Meeting the Challenges Facing Clinical Research: Solutions Proposed by Leaders of Medical Specialty and Clinical Research Societies

Murillo, Horacio, MD, PhD; Reece, E Albert, MD, PhD, MBA; Snyderman, Ralph, MD; Sung, Nancy S., PhD

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The development of a robust national clinical research enterprise is needed to improve health care, but faces formidable challenges. To define the impediments and formulate solutions, the Institute of Medicine's Clinical Research Roundtable convened leaders from medical specialty and clinical research societies in 2003. Participants considered how to influence clinical research funding priorities, promote mechanisms to train physicians and other health care professionals to conduct clinical research, and how to encourage health care providers to follow evidence-based medical practice. Consensus emerged on multiple issues, including intersociety collaboration, the need for a core clinical research curriculum for training the new cadre of clinical researchers, joint advocacy for increased funding of clinical research and for the education of policymakers and the public on the benefits of clinical research. Specific recommendations were made on mechanisms for recruitment, training, and retention of clinical research trainees and mentors. Steps were outlined (1) to overcome career disincentives and develop appropriate reward systems for mentors and trainees, (2) to encourage use of web-based and continuing-medical-education-based mechanisms to bring practitioners up to date on issues in and results of clinical research, and (3) to create incentives for individuals, clinics, and hospitals to practice evidence-based medicine (EBM). Collectively, the response and proposed strategies can serve as a roadmap to improve clinical research funding and training, evidence-based medical practice, and health care quality.

Dr. Murillo is an American Association for the Advancement of Science Congressional Fellow, Washington, D.C.

Dr. Reece is vice chancellor, University of Arkansas for Medical Sciences, and dean, College of Medicine, University of Arkansas for Medical Sciences, Little Rock, Arkansas.

Dr. Snyderman is chancellor Emeritus and James B. Duke Professor of Medicine, Duke University Medical Center, Durham, North Carolina.

Dr. Sung is senior program officer, Burroughs Wellcome Fund, Research Triangle Park, North Carolina.

Correspondence should be addressed to Dr. Reece, Vice Chancellor, University of Arkansas for Medical Sciences, 4301 W. Markham, Slot 550, Little Rock, AR 72205; e-mail: 〈reeceealbert@uams.edu〉.

Life is short, science is long, opportunity is elusive, experiment is dangerous, judgment is difficult. It is not enough for the physician to do what is necessary, the patient and the attendants must do their part as well, and circumstances must be favorable.

—Hippocratic writings

Though presumably written nearly 2,500 years ago,1 these pearls of Hippocratic wisdom have a striking resonance with the ailments of our current health care and clinical research enterprise. We are rediscovering that to improve health care quality and medical sciences to best serve our needs, many players, activities, and circumstances must be harnessed and brought together in a careful and concerted manner. To this end, in 2003, the Institute of Medicine's Clinical Research Roundtable brought together the leaders of medical specialty and clinical research societies to address how they could contribute to overcoming the challenges facing the clinical research enterprise. These stakeholders (see List 1) were asked to propose lists of “what to do” and “how to do it” suggestions, in response to the broad vision and strategy outlined by Sung et al.2 on workforce training and funding challenges. In this article, we present their responses to the challenges posed by clinical research workforce needs, training, research priorities, and the practice of evidence-based medicine (EBM).

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The Challenges

Information flowing from the clinical research enterprise directly influences over the cost, quality, and efficiency of our health care system. As our population ages we face further challenges such as the increased prevalence of chronic disease. The pressure for our clinical research enterprise to produce high-quality information and to speed the translation of advances from basic science to clinical care, and then to better health, will continue to grow.2–6 Among the many challenges faced by the nation's clinical research enterprise is the shrinking clinical research workforce that has been noted for decades.2,3,7–9 This trend is not limited to physician investigators but now involves the full spectrum of clinical researchers (dentistry, nursing, pharmacy investigators etc.).2,9,10 Other challenges include the need to communicate the relevance of clinical research findings to health care providers, the need for evidence-based medical practice, and the need for research that addresses health disparities.4–6,11–14

Despite the importance of clinical research, a variety of factors discourage young candidates from entering clinical research careers. The training is long, there are insufficient numbers of mentors, and salaries for physician investigators do not approach those that can be obtained in medical practice.2,3,15 Many academic investigators have a difficult time juggling patient care, grant writing, and raising families. Physician scientists also often feel that there is insufficient appreciation for their efforts, choosing to abandon the research path, as evidenced by low first-time and reapplication rates for grant funding from the National Institutes of Health (NIH). Moreover, funding for clinical research can be more difficult to secure than funding for basic biomedical research.15–17 Collectively, these factors add up to significant impediments and limitations for young health professionals entering clinical research careers. Solutions are urgently needed, especially given the heightened expectations of the public to receive health care benefits from its investment in research.2,3 No matter how much additional basic and disease-oriented research knowledge accumulates in the life sciences, little progress will be made in translating them into health benefits without sufficient numbers of clinical as well as “translational” researchers: those whose work spans the gap between basic science and clinical medicine.

There is great variability nationwide in the type and quality of health care delivered in the United States. Even when clear guidelines are disseminated, they are not always followed.5 Expanding the use of evidence-based knowledge in the day-to-day decision-making process of the average health care provider requires both better evidence and new skills. More research on the effectiveness of therapies and interventions in practice-based settings is needed.6 In addition, all health care providers who practice EBM need to know how to access and search the literature, how to evaluate study results, how to integrate clinical impressions from individual patients, and how to exercise one's best judgment of all the factors considered.6,12–14

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A National Meeting to Address the Challenges

To address the challenges mentioned above, in September 2003, the Institute of Medicine's Clinical Research Roundtable convened 31 medical specialty and clinical research societies at the National Academies of Science to discuss how societies can influence clinical research funding priorities, promote mechanisms to train physicians and other health care professionals to conduct clinical research, and encourage health care providers to follow evidence-based medical practice. At the meeting, leaders (presidents, executive vice presidents, senior vice presidents, chief medical officers or designees) from 314 specialty medical or clinical research societies, five foundations, three health insurance companies, two academic institutions, two pharmaceutical companies, and the Centers for Medicare and Medicaid Services were represented.

Representatives divided into three workgroups to discuss recommendations for societies and others that address the key concerns outlined above. The workgroups used a modified nominal group methodology18 to identify solutions, and at the end of the discussion developed recommendations voted upon by all group members. Workgroup chairs presented the results to all participants in the plenary session.

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Summary of the meeting's discussions

The major challenges addressed by the convened stakeholder participants were recruitment and retention of clinical researchers, mechanisms of clinical research training, clinical research funding, tenure and promotion metrics for clinical researchers, and the promotion of evidence-based medical practice. Participants noted that attrition of potential clinical investigators occurs at each transition point along the career development continuum from entrance into professional schools through the midcareer stage. (See Figure 1 for a representation of the clinical researcher career pipeline.) All participants recognized the need to target interventions at the earliest possible stage, as well as the need to address the ‘leaks' in the pipeline that contribute to attrition at all stages.

Figure 1

Figure 1

First, of all the matriculating health professions students, only a small percentage express an interest in research careers, a pattern that has been constant over time.3,8,10 An even smaller percentage actually enters research careers, leading to a diminished and inadequate base of qualified researchers who can take advantage of the enormous opportunity to translate current basic science discoveries into tangible health benefits. One partial solution to this problem would be to increase awareness of health care research careers at the undergraduate and high school levels. The stakeholders at the meeting believed that such a strategy would potentially increase the recruitment base within professional schools.

Second, the long and costly educational journeys for health care professionals lead to significant debt burden. This can pressure potential candidates to pursue more financially rewarding careers, which are not available in research fields. Solutions to this problem include expanding loan repayment programs as well as creating more competitive compensation packages for those choosing research careers. Third, early career funding mechanisms need to be developed to support the critical transition of trainees into their first permanent research positions. Attrition at this juncture is costly, given the investment in training. While no comprehensive evidence exists in support of these proposed solutions, there are some signs that recent funding and training initiatives are having a positive effect. Bakken et al.19 report that the majority of early graduates of NIH-funded K-30 programs have gone on to attract extramural funding for their research. Interest in research among both matriculating and graduating medical students is also on the increase.20

At an organizational level, the medical specialties and clinical research societies agreed that a joint tracking mechanism to assess and monitor the success of recruitment and retention efforts was needed. Likewise, advocacy for increasing funding of clinical research and training was considered likely to have better yields if done jointly. In particular, it was felt that a united platform could afford professional societies better success at advocating flexibility on qualifications for funding of trainees at early stages of their careers. New investigators often find themselves in a futile circle of not having enough of a track record and preliminary data to secure funding, but not having enough funding to establish a track record either. By working together, professional clinical research societies could develop and encourage mechanisms that provide continuity of funding through the various stages of training and especially early career development.

The convened stakeholders agreed on the need for professional societies to consider themselves stewards of the research activities of their members. By developing, promoting, and implementing their priorities for clinical research while using their power with policymakers and the public, professional societies could have a significant impact on the overall clinical research agenda and funding priorities. A formal collaboration of clinical research societies would multiply this impact (Figure 2). Such a collaborative federation of clinical research societies could develop and promote joint consensus statements and career-development strategies, could establish formal mechanisms for intersociety collaborations, and could harmonize clinical research agendas.

Figure 2

Figure 2

Recommendations for actions to improve the workforce of clinical investigators are presented in List 2. Essential to “basic” training in clinical investigation are a core curriculum and practical research experience, which can be further focused to specialty areas of clinical research as desired. Successful completion of such a clinical research training program should be documented in the form of a degree or certificate. Health professions students (dental, medical, nursing, pharmacy, etc.) should be exposed to clinical research as a standard part of training and at the earliest possible time.

Wherever appropriate, the individual and collaborating societies' leadership should encourage specialty board examination bodies to include clinical research competencies in their core education and continuing education requirements. Likewise, this leadership should champion the spirit and value of scholarship and the clinical research training enterprise within their membership groups. This aim can be accomplished collaboratively through web-based advertising and content delivery, use of annual national meetings with educational workshops, and recognition awards.

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Response to specific challenges

Facilitating mentor training models.

Institutions need to protect the mentor's time for nurturing trainees (see List 2). Whenever possible courses or classes on how to be an effective mentor should be developed and implemented. Institutions should develop and support core group(s) of mentors for their clinical research and clinical research training enterprises, possibly drawing upon the experience of emeritus faculty. Likewise, meritorious mentorship should be considered as an important factor in the promotion and tenure metrics used by institutions.

The assembled professional society leaders also emphasized the need to advocate standardized academic promotion guidelines tailored to clinical researchers, whose work is distinctly different from that of basic science faculty. For example, in clinical research, functioning as a member of a team is essential to success, yet teamwork is not traditionally rewarded with academic promotion and tenure.

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Clinical research priorities and underfunded areas.

In view of the need for multiple stakeholders to tackle the complex problems surrounding clinical research priorities and funding, it was recommended that an ongoing forum for integrating efforts should be established Such a forum of medical research societies could, among other functions, offer the opportunity to develop a harmonized research agenda, for example, by tackling co-morbid conditions whose research questions both cross specialty areas and are of high significance to public health.

The convened participants expressed a strong need for increased funding for effectiveness research, which includes outcomes and health services research, and comparative studies of new versus standard therapies. Research on the outcomes of noncommercial interventions—such as nonpatentable drugs, lifestyle, and behavioral modifications, as well as research into racial, gender, and socioeconomic disparities in health care outcomes and utilization—were considered particularly underfunded. These areas were considered likely to have the greatest yield for practical, everyday results that could greatly improve patient care and quality (see List 3).

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Strategies to encourage the practice of EBM.

Participants articulated four principles to guide societies in the promotion and enhancement of evidence-based medical practice. First, societies have an ethical obligation to spearhead improvements to the quality of care. Second, societies have a responsibility to develop, promote and support implementation of EBM (see List 4). Third, the respective societies and stakeholders have a responsibility to evaluate implementation of guidelines for evidence-based medical practice and quality improvement efforts (alone or in collaboration). Fourth, the societies and stakeholders have a responsibility to work with other stakeholders to implement guidelines. In doing so, a collaborative approach would harmonize efforts, promote efficiency, enhance efficacy, decrease redundancy, and would increase success (see List 4). Underlying these principles is the need to educate specialty societies' membership, physicians, health care providers, medical students, and the public regarding the role of EBM and EBM-fostered quality improvement.

It was felt that professional societies' recognition of those members who exemplify evidence-based medical practice would serve as an incentive to others. Such recognition could take the form of awards as well as the use of continuing medical education (CME) credits for specific courses related to EBM. Prospective data-capture with feedback to hospitals, teams, or individual health care providers was also believed to be an important mechanism to implement. Promoting practical clinical trials, as well as research on the success of the use of preventative measures, barriers to compliance, socioeconomic issues, and health habits would greatly add to the practical knowledge needed to promote EBM habits among health care providers.

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Summing Up

The convened stakeholders, including professional society leaders as well as representatives from several private foundations, voluntary health agencies pharmaceutical companies, health insurers, and academic health centers, proposed the need for

  • ▪ increasing intersociety collaborations to unify and strengthen their efforts for recruitment, training and retention of a new cadre of clinical researchers;
  • ▪ forming of a federation of clinical research societies that could ensure a unified advocacy effort and a harmonized agenda for clinical research and clinical research training, including increased funding;
  • ▪ optimizing clinical effectiveness research so that clinical research findings could be best understood and applied by health care providers;
  • ▪ promoting of evidence-based decision-making tools to be used more often and consistently, nationwide; and,
  • ▪ advocating and championing the value and merits of the clinical researchers at the local and national levels by the respective stakeholders. For clinical investigators, the value of strong advocacy from the stakeholders' leadership could greatly increase the appeal and virtues of a clinical research career, thus attracting young candidates and reaffirming the meaningfulness and rewards of being a clinical researcher.

The societies and stakeholders articulated a need to support clinical research careers throughout the medical education continuum, from medical school through residency, postgraduate education, and CME. Emphasis was placed on a commitment to generous support during the early stages of clinical research careers to maximize the likelihood of retention and success in career development. Formal collaboration mechanisms should be established and implemented across the various specialty societies, foundations, and other stakeholders to provide a cohesive framework and infrastructure to support clinical research career development.

It remains an imperative to advocate and promote the conduct of practical clinical research trials as proposed by Tunis et al.6 Knowledge gained from such studies is likely to improve evidence-based medical practice and health care delivery nationwide. With professional societies facilitating the continuing education of health care providers, and with an infrastructure to manage the knowledge emerging from such trials, greater and more uniform use of evidence-based decision making in the care of individual patients will be realized and health care delivery markedly improved.

As stated in the Hippocratic writings, all stakeholders must come together to participate and contribute to solving the enumerated challenges. The circumstances will then become more favorable for health professionals to enter and stay in clinical research careers. The number of mentors and standardization of training mechanisms will improve. A comprehensive research infrastructure will be easier to develop to support trainees, mentors, and the translation of more research findings into health benefits that the public expects. Furthermore, as all stakeholders do their part, including advocacy efforts directed toward the public and policymakers, adherence to evidence-based medical practice will be rewarded and therefore become more widespread. Medical specialty and clinical research societies will be able to better carry out their missions and improve health care quality. The more that the diverse stakeholders can harmonize their work, the less will be the weight that any one entity will bear, and the easier and more efficiently their goals will be achieved.

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Disclaimer

The views expressed in this article are those of the authors and do not represent the views of the Institute of Medicine, the Clinical Research Roundtable, or the Roundtable's sponsoring organizations.

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