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Solutions and Strategies from Medical and Nursing School Leadership for the Challenges Facing the Clinical Research Enterprise

Murillo, Horacio MD, PhD; Reece, E Albert MD, PhD, MBA

doi: 10.1097/ACM.0b013e318065b4f9
Research Issues

Purpose: For decades, the U.S. clinical research enterprise and its workforce have faced diminishing numbers and significant challenges. This study, conducted by the Institute of Medicine’s Clinical Research Roundtable (CRR), sought to learn about the perceptions by medical and nursing school deans of these challenges or the efforts and strategies needed to address them.

Method: The authors mailed structured questionnaires about clinical research and workforce issues to medical and nursing school deans in the continental United States in the fall of 2003, and on October 16 and 17, 2003, the CRR held a two-day workshop with deans and their representatives to discuss the survey findings and to propose solutions.

Results: Survey participation was 55 (45%) for medical school deans and 37 (46%) for nursing school deans. Various efforts exist at individual schools for recruitment, training, and retention of clinical researchers. Most of the responding medical (53; 96.7%) and nursing (28; 75.4%) school deans reported that demand for clinical researchers exceeded or sharply exceeded supply, and about half of these institutions had a formal mentor program for their students. The percentage of graduates with methodological training in clinical research varied widely, with a mode of 10% and 100% for medical and nursing schools, respectively. Most medical school deans (47; 85.5%) rated their basic research enterprises good to excellent, whereas only a third (19; 34.6%) rated their clinical research programs similarly. Likewise, nursing school deans rated their basic research programs more favorably (23; 62.2%) than they rated their clinical research enterprises (17; 46.0%). However, prioritization of changes needed to address the challenges facing clinical research and its workforce were similar for medical and nursing school deans.

Conclusions: Clinical research is underdeveloped and underrepresented within the clinical research enterprise. There is a need to develop and execute uniform strategies to grow and expand the clinical research workforce. Workshop participants, including 14 deans or their representatives as panelists and CRR members, proposed solutions and strategies.

Dr. Murillo is resident physician, Department of Radiology, University of Texas Health Science Center San Antonio, San Antonio, Texas.

Dr. Reece is vice president for medical affairs, University of Maryland, and dean, University of Maryland School of Medicine, Baltimore, Maryland.

Correspondence should be addressed to Dr. Reece, Vice President for Medical Affairs, University of Maryland School of Medicine, 655 W. Baltimore Street, Room 14-029, Baltimore, MD 21201; telephone: (410) 706-7410; fax: (410) 706-0235; e-mail: (

Clinical, translational investigators are the critical players at the interface of patient care and the accumulating wealth of basic research knowledge. With mounting biomedical research findings and public expectations for their translation into health benefits, the problem of diminishing and aging numbers of clinical investigators (physicians, nurses, dentists, pharmacists, and others) can no longer be ignored.1–8 The number of U.S. physicians who are clinical investigators declined 38% in the last decades of the 20th century, from 23,214 in 1984 to 14,357 in 1999.9 In the same period, the total number of physicians in the United States rose 32%, from nearly 480,000 to approximately 707,000.9,10

Of equal or greater concern are the inadequate numbers and shortages of nurse investigators, who, like their physician counterparts, have suffered from attrition and aging.11,12 Of the approximately 16,730 doctoral registered nurses (RNs) in 2000, 9,000 were involved in education or research—a number essentially unchanged from 1980, except that the RN population increased by more than a million during the same two decades.11 Given these shortages in the clinical research workforce and its educational and training base capacity, it is not surprising that challenges exist with the pace of translating biomedical research findings into health benefits.

Clinical research nurses, who are a central component of clinical research protocols and trials, are usually drawn from the existing nurse workforce. The eighth national sample survey of RNs in the United States shows that from 1980 to 2004, the age of the largest fraction of nurses shifted from the upper 20s to 50 years of age.12 In 1980, 17.2% of RNs were older than 54 years; in 2004, this age group increased to 25.5%. Similarly, in 1980, 52.9% of RNs were less than 40 years old, and in 2004, this age group’s size dropped to 26.6%. Thus, workforce shortages for clinical research have reached critical levels and stages, requiring urgent and concerted action by deans and other leaders at academic health centers (AHCs).

To spur dialogue and collectively find solutions to these needs, the Institute of Medicine’s Clinical Research Roundtable (CRR) conducted a survey of medical and nursing school deans in the fall of 2003, and on October 16 and 17, 2003, the CRR convened a workshop on issues relevant to the clinical research enterprise and its workforce, with a panel of deans and CRR members. The survey was conducted with anonymity assured to encourage candid feedback. The findings showed significant awareness of the shortages in the clinical research workforce endured for decades, but without uniformity of efforts or strategy to solve the problems. We report the aggregate survey findings and the proposed solutions articulated at the workshop by the panelist group of medical and nursing school deans or their representatives and the CRR members.

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Survey and workshop

In the fall of 2003, we and CRR support staff mailed structured survey questionnaires to the deans of the 123 medical schools and the 81 nursing schools in the continental United States that offered doctoral programs. During a three-month period, we sought their perceptions and assessments of current clinical research challenges and workforce issues, in general and at their respective institutions, and we assured them anonymity. Questions about three broad areas were included in the survey: workforce needs, including supply and demand for clinical researchers; robustness of basic and clinical research disciplines; and prioritization of changes needed to advance the clinical research enterprise. The survey questionnaires were sent by mail to the deans. If no response was received, we sent up to two e-mails, followed by a reminder telephone call. All deans were instructed to anonymously return their questionnaires. The questions in the survey instrument were the same for both medical and nursing school deans within the contexts of their respective schools.

A two-day workshop was held to discuss the survey’s findings and to gather input on approaches to address clinical research needs and challenges from a small but diverse group of deans suggested by the Association of American Medical Colleges to serve as discussant panelists. Considerations given to the composition of the panel of deans included (1) willingness to participate with short notice, (2) goal of a panel of 12 deans that included representatives from private and public AHCs with a medical and or nursing school, and (3) broad geographic distribution of institutions from throughout the country. Two additional deans were invited to ensure meeting the goal of 12. All 14 deans who were invited to participate as panelists accepted. The 14 invited deans or their representatives attended the workshop and served as a panel for analysis and discussion of the survey findings with CRR members. Collectively, attending deans and CRR members developed lists of strategies on how to address the needs of the clinical research enterprise and its research workforce, which we report in this article.

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Data analysis

Answers to survey questions were tabulated for each school group of deans. To facilitate comparisons, the total number of responding deans of medical schools was treated as 100%, and the total number of responding deans of nursing schools was treated as a second 100%.

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Survey findings

The number of survey participants was 55 (45%) for medical school deans and 37 (46%) for nursing school deans. When medical school deans were asked about supply and demand of clinical researchers,

* 24 (43.5%) of the responding deans said demand sharply exceeded supply,

* 29 (53.2%) felt demand exceeded supply, and

* 2 (3.6%) felt that demand equaled supply.

On the same question,

* 5 (13.5%) of the responding nursing school deans indicated that demand sharply exceeded supply,

* 23 (62.2%) stated that demand exceeded supply,

* 5 (13.5%) considered demand equal to supply, and

* 3 (8.1%) of responders stated that supply exceeded demand.

No medical school deans’ responses indicated that supply sharply exceeded or exceeded demand of clinical researchers, and no nursing school deans’ responses indicated that supply sharply exceeded the demand for clinical researchers. Irrespective of their supply and demand views, only 30 (55%) of responding medical school deans and 18 (49%) of nursing school deans indicated that their institutions had formal mentoring programs for their students.

To understand educational and training components related to clinical research at medical and nursing schools, one question asked deans to estimate the percentage of graduates who had had training in clinical research methodology. The estimated percentages were highly variable, ranging from 0% to 100%, but the mode equaled the median for the percentages given by both the responding medical school deans and nursing school deans (10% and 100%, respectively). A related question, only asked of medical school deans, requested estimates of the percentage of their graduates who had directly assisted in clinical research studies. These estimated percentages also varied from 0% to 100%, with a mode and median of 5% and 15%, respectively.

All deans were asked to express the overall health and robustness of their basic research, clinical research, and health services research programs by rating them as excellent, good, average, poor, or very poor (Figure 1). The health and robustness of the basic research enterprise received the highest ratings from both medical school deans (47; 85.5%) and nursing school deans (23; 62.2%). Clinical research and health services research received similar ratings.

When all deans were asked to estimate the percentage of research income to their institutions from basic research and two major categories of clinical research, health services research, and patient-oriented research, medical school deans’ estimates averaged 63.4% for basic research, 24.0% for patient-oriented research, and 12.0% for health services research, respectively (Figure 2). Nursing school deans’ estimates were 40.1%, 45.1%, and 14.2%, respectively, showing that their greatest expected contributions would come from clinical research (health services research and patient-oriented research).

The questionnaire further asked all deans to express their views on the priority and urgency of funding training, appropriate information technology (IT) systems, public understanding and engagement, regulatory requirements, and institutional support and liability for the conduct of clinical research (Figure 3). Deans were asked to rate these issues on a scale of 1 (high) to 5 (low) for changes needed from the current state of affairs. For medical school deans, training, funding, and regulatory-burden changes were top priorities. The top three priorities for nursing school deans were funding, training, and IT systems. Unlike medical school deans, nursing school deans gave higher priority to IT systems than to regulation burden. Both groups of deans gave the least priority to institutional support and liability associated with conducting clinical research compared with the other issues.

CRR members and clinical research stakeholders had previously identified other issues important to clinical research and its workforce. These issues were diversity, training of physicians or nurses to participate in clinical research, their training to use recent research findings in their practice, and training of allied health professionals (AHPs) to participate in clinical research activities. The majority of responding deans—49 (89%) of medical school deans, and 32 (86%) of nursing school deans—agreed that training of physicians or nurses to participate in clinical research, funding of clinical research training programs, and training of individuals to understand and apply results from clinical research studies were the most pressing (Figure 4). Notably, diversity and AHP training received lower priority from both groups of deans.

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Workshop deliberations and recommendations

The majority of CRR members and stakeholders attended the workshop to discuss the survey findings and engaged with the convened deans panel (see List 1) to collaboratively develop solutions and strategies to address the challenges facing the clinical research enterprise and its workforce. The three major challenges the group identified were the low numbers of clinical researchers and of individuals attracted to clinical research careers, the limited incentives and funding, and multifactored attrition and aging. The discussions centered on how deans at the doctoral level health professions schools are approaching these challenges and what could be done to improve the current approaches in view of the survey findings.

The workshop participants recognized the differences between nursing and medical school deans’ responses to the survey questions. Although it was clear why the deans of each type of school assigned different priorities to issues such as diversity versus training of AHPs, participants felt that there was a pressing and fundamental need for a uniform approach to the challenges faced by the clinical research enterprise and its workforce.

In this context, foremost was the need to increase the numbers of individuals who are attracted to and interested in clinical research careers (List 2 presents the major strategies agreed upon). These efforts should be aimed at the earliest possible level in the pipeline. Second, the teaching and training at the doctoral level health professions schools should uniformly include certain components customized to the interest of the students (these are summarized in List 3). Third, the institutional leadership and support for increasing the numbers going into and staying in clinical research careers needs to be robust and proactive (List 4 presents recommended solutions and strategies). Whether it is a medical, nursing, or other health professions school that is concerned with the clinical research enterprise challenges, lack of uniformity of purpose and action could continue to undermine individual efforts.

Schools offering clinical research training programs should reach out to junior and high school students to introduce students to clinical research careers (List 2). Given the need and the drive to increase the overall number of individuals going into such careers, this is also an opportune time to increase the diversity of the workforce to include women and members of other traditionally underrepresented groups. The outreach programs should take steps to foster clinical research careers such as early exposure to clinical research experiences and undergraduate summer research internships. Simultaneously, these outreach efforts can offer a strong recruitment base and a conduit to increasing the numbers of individuals going into clinical research careers, rather than waiting for the development of interest at the entrance to health professions schools.

It was understandable to see that medical schools trained an average of about 10% of their graduates in clinical research methodology, whereas nursing schools trained 100% of theirs. The surveyed nursing schools were PhD-granting institutions, and their graduates would be expected to focus on research. The medical schools’ average could be related to the percentage of those interested in clinical research careers (around 10%) clearly seeking training and related experiences. However, the workshop participants felt that, given the importance of research to new knowledge and medical practice, certain teaching components needed to be uniform at these schools (List 3). Teaching at such schools should include the fundamentals of clinical research methodology, regardless of career orientation. Hands-on experience in clinical research should be uniformly encouraged, although not required, for those going into clinical practice only. An understanding of clinical research ethics and regulation could benefit all students, even those not planning a research career.

For those students going into research careers, mentors should be available to all, as should be the teaching of grant-writing skills. The clinical research training programs should provide a learning environment that mimics the environment of dedicated clinical researchers. Namely, it should engage students to carry out cross-disciplinary collaboration exercises and learn grant writing and regulation and policy issues. Given that the long-term commitment to training for clinical research careers can be discouraging, programs should strive for shortening the time commitment wherever possible. The institutional and mentoring support should be geared towards individual as well as general needs, including those of women and other underrepresented groups.

The dean’s key leadership role at institutions for internal and external initiatives should be used proactively to advance the clinical research enterprise (List 4). Engaging and educating the public and policy makers is essential to increasing participation in clinical trials, clinical research activities, and funding support. The public’s improved appreciation for research and their understanding and engagement in this process could spur their advocacy for increased funding for clinical research and training. Moreover, developing and implementing appropriate collaborative interactions with private-sector stakeholders, such as insurance companies and pharmaceutical and medical device industries, have the potential to enhance or achieve synergy on common goals such as the clinical research training of new investigators. Examples of such activities include giving clinical research grants to young investigators, establishing educational loan-repayment programs and training fellowships, providing informatics resources, and convening training workshops at AHCs and industry sites. Making clinical research a top priority for any institution should not detract from its basic research enterprise. Indeed, the latter strength should be leveraged to develop collaborations between basic and clinical researchers and to attract and retain individuals with diverse backgrounds.

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The heightened expectations by the public to translate more of the accumulating life sciences knowledge into health benefits has brought the topic of shortages of clinical researchers to the front line.6–9 Although this survey’s findings seem dated, the challenges have only worsened over the past three years, and the collective recommendations here are as applicable today as they were when they were first articulated. Nurses and physicians, who are the two largest contributors to the clinical research workforce, continue to leave clinical research because of aging and other reasons, further undermining their numbers and ability to sustain recruitment and retention of a new cadre of clinical and translational investigators.11–13 Moreover, as in the case of dentist and pharmacist investigators, nurses and physicians have numerous opportunities and career choices besides research, which effectively compete with translational research careers.12,14–16 Thus, incentives and rewards for choosing clinical research professions will need to be expanded. This expansion would need joint efforts between the AHC’s leadership and the public, which must be engaged in order to educate policy makers and other stakeholders.

In general, our survey findings from deans of medical and nursing schools regarding change priorities are consistent with the previously reported leadership perceptions and views on clinical research.14,17 Nevertheless, limitations in our survey tool are worth noting. First, the survey questionnaire was structured and thus asked deans to select from the limited answer choices given. No options were given for the deans to express any other views on any of the questions, potentially limiting insights gained on the specific issues. Only three months were given to participate in the survey. This time constraint might have had an influence on how many deans responded, thereby limiting sample size. However, these survey features were balanced with the prospect of sending lengthy, time-consuming questionnaires and giving more time for responses. Therefore, the survey findings need to be considered in the context of these limitations.

A potential bias in the survey responders and the panelist deans could be the level of research intensity at their respective institutions. Not all surveyed institutions may consider their clinical research missions a priority, leading to disparate answers on the views of their deans regarding clinical research and workforce issues compared with the convened deans and CRR members. Although the convened deans were mainly from research-intense institutions, the questionnaires returned that could be traced back to institutions were widely distributed among research-intensive and non-research-intensive institutions. There was no pattern of answers to specific questions according to the type of school. For example, indicating the presence and absence of mentoring programs or training in clinical research methodologies did not correlate with the level of research intensity of the institution. The assured anonymity of the survey was intended to encourage candidness in answering the survey questions.

The concerns and potential solutions acknowledged by the convened medical and nursing school deans’ panel bear striking similarity to those put forth by other stakeholder groups.8 A panel of 31 leaders of medical specialty and clinical research societies, also convened by the CRR in 2003, noted that the cadre of clinical researchers suffers losses, like leaks in a pipeline, at key points such as the transition from medical, nursing, or other professions schools into research fellowships and other early-career training positions. The specialty groups’ panel recommended intervention measures that span the medical education and career continuum. In addition to boosting students’ exposure to clinical research in the core curriculum, academic institutions should support and reward clinical and translational research mentors and investigators. Necessary steps include providing protected research and mentoring time, infrastructure support, tailored promotion, and tenure metrics that reward clinical research and mentoring.

Answers to questions on institutional support and liability for clinical research, training of AHPs, and diversity revealed unique perspectives from deans. One interpretation of the low ratings given to institutional support and liability for clinical research from all deans is that, in general, surveyed medical and nursing school institutions are very supportive of the clinical research enterprise. The low priority for the training of AHPs by nursing school deans suggests a varying need for AHPs in the research activities of such schools compared with medical schools. Alternatively, it may suggest that such AHP assistance is already adequate at nursing schools. The workshop participants favored the former view.

Interpretation of the priority ratings given to diversity issues was complex. Fewer than half of the responding medical school deans gave it a high priority rating. Workshop participants felt that diversity at this point in time deserved higher priority. Diversifying the translational research workforce has enormous potential not only to increase gender and ethnic representation so that the translational research workforce will reflect the national population, but also to overcome the gender and socioeconomic disparities in health care and research that prevail today.18–21

Demographic predictions suggest that underrepresented groups will soon become well represented in the population.18,22–24 Therefore, this is an opportune time to include diversification efforts in the general strategy to increase and expand the clinical research workforce. The percentages of individuals from underrepresented groups expressing interest in research careers on entering medical school, for example, are equivalent to those of well-represented groups.18 Therefore, the diversity shortcomings may be caused less by the fact that fewer members of underrepresented groups are expressing interest in research careers and more by the fact that fewer members of such groups are attending health professions schools. Thus, workshop participants emphasized the need to make diversity efforts a top priority.

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Although PhD-trained researchers have managed to maintain a robust workforce that has been able to adapt to the changing times and needs, clinical researchers have not fared as well.10,13 Uncoordinated efforts by individual health professions schools and AHCs may no longer be tenable, and the proposed solutions and strategies outlined above, if broadly implemented, promise to overcome the status quo challenges facing the clinical research enterprise and its workforce. Although health professions school deans may have limited, direct influence over funding for clinical research, workforce issues can be directly influenced, and deans can play a substantial role. These efforts include coordinated action for recruitment, training, career development, and retention of individuals going into clinical research careers.

Summarized below are the key recommendations of the workshop group:

* To overcome the diminishing numbers and aging challenges, develop and execute coordinated outreach to junior- and high-school-level students and provide progressive opportunities to young adults. Significant impact on career tracking can be achieved at these stages.25–27 Increasing the proportion of young investigators in all the health professions school disciplines will overcome the aging challenges across the workforce’s spectrum.

* To overcome traditional clinical research career disincentives and funding, engage the public and educate policy makers about the need for a robust clinical research enterprise and workforce. Team up with other stakeholders who can also contribute support and resources to these initiatives. Wherever possible, strive for shorter training time commitments across the health professions disciplines. Focus efforts on diversity and individual support for professional development.

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The authors acknowledge the important contributions of all workshop participants, survey respondents, and Clinical Research Roundtable members.

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The views presented in this report are those of the authors and not of the Institute of Medicine, the Institute of Medicine’s Clinical Research Roundtable, or the Roundtable’s sponsoring organizations.

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