Clinical and Translational Research

Defining Translational Research: Implications for Training Doris McGartland Rubio, PhD, Ellie E. Schoenbaum, MD, Linda S. Lee, PhD, David E. Schteingart, MD, Paul R. Marantz, MD, MPH, Karl E. Anderson, MD, Lauren Dewey Platt, PhD, Adriana Baez, PhD, and Karin Esposito, MD, PhD

Abstract Because translational research is not translational research and proposed an individual institutions and individual clearly defined, developers of operational definition to use in the trainees within the institutions but that it translational research programs are educational framework. In this article, must also be rigorous enough to struggling to articulate specific program the authors posit that translational document that the program is meeting objectives, delineate the knowledge and research fosters the multidirectional and its short-, intermediate-, and long-term skills (competencies) that trainees are multidisciplinary integration of basic objectives and that its trainees are expected to develop, create an research, patient-oriented research, and meeting preestablished competency appropriate curriculum, and track population-based research, with the requirements. A logic model is proposed outcomes to assess whether program long-term aim of improving the health of for the evaluation of translational the public. The authors argue that the objectives and competency requirements research programs. are being met. Members of the approach to designing and evaluating Evaluation Committee of the Association the success of translational training Acad Med. 2010; 85:470–475. for Clinical Research Training (ACRT) programs must therefore be flexible reviewed current definitions of enough to accommodate the needs of

The National Institutes of Health Research Training (ACRT), we began to practical problems, though it may not (NIH) has traditionally supported the address this problem by reviewing the give a complete specific answer to any one training of basic and clinical scientists in definitions of different types of research. of them. The function of applied research is to provide such complete answers.4 a variety of disciplines. More recently, it We then developed working definitions has supported the training of scientists in of translational research and associated The NSF definition thus identifies the translational research through the K30 terms. Here, we present our working main objective of basic research as the and Clinical and Translational Science definitions, discuss their implications for acquisition of knowledge without the Award (CTSA) programs.1 Because both educational training programs, and offer obligation to apply it to practical ends. basic research and clinical research are a framework to guide institutions in clearly defined, developers of programs to developing processes of program Basic research training is pervasive in train individuals in these types of evaluation. medical schools. With PhD programs research have been able to articulate offered in disciplines such as the program objectives, delineate the biomedical sciences, computational knowledge and skills (i.e., competencies) Definitions of Basic Research and biology, and neuroscience, the basic that trainees are expected to develop, Basic Science science field has been well established. create an appropriate curriculum, and According to the American Cancer Competencies within the basic sciences track outcomes to assess whether Society, basic science involves laboratory have been clearly defined, allowing for program objectives and competency studies that provide the foundation for effective development and evaluation of requirements are being met. In contrast, clinical research.2 As one cancer center educational programs. About 60% of the because translational research is not indicates, basic science entails gathering NIH budget is allocated for basic clearly defined, developers of knowledge that is essential for applying research, and most of the basic research translational research programs are discoveries to patient care.3 However, in funds go to PhD scientists.5 struggling with some of these processes. 1945, when the director of the U.S. Office of Scientific Development and Research As members of the Evaluation Definitions of Clinical Research Committee of the Association for Clinical proposed the establishment of the National Science Foundation (NSF), he In 1997, the NIH Director’s Panel on made the following distinction between Clinical Research issued the following Please see the end of this article for information basic research and applied research: three-part definition of clinical research: about the authors. Basic research is performed without (1) Patient-oriented research. Research Correspondence should be addressed to Dr. Rubio, thought of practical ends. It results in conducted with human subjects (or on Division of General Internal Medicine, Department of Medicine, University of Pittsburgh School of general knowledge and an understanding material of human origin such as tissues, Medicine, 200 Meyran Ave, Suite 200, Pittsburgh, of nature and its laws. This general specimens and cognitive phenomena) for PA 15213; telephone: (412) 692-2023; fax: (412) knowledge provides the means of which an investigator (or colleague) 246-6954; e-mail: [email protected]. answering a large number of important directly interacts with human subjects.

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Excluded from this definition are in vitro molecular genetics and immunology). incidence, morbidity, and mortality.”12 studies that utilize human tissues that Today, the literature includes a plethora But, given that basic research and clinical cannot be linked to a living individual. of attempts in various fields to define the research involve inherently different Patient-oriented research includes: 8 (a) mechanisms of human disease, term. knowledge sets and methodologies, (b) therapeutic interventions, (c) clinical including both of them in the same trials, or (d) development of new In a recent announcement about segment of the continuum (i.e., in T1) technologies. applying for a CTSA, the NIH offered the obscures the fact that multidisciplinary following definition: translational research can also occur at (2) Epidemiologic and behavioral studies. the interface of basic and clinical science. Translational research includes two areas (3) Outcomes research and health services of translation. One is the process of research.6 applying discoveries generated during A Framework to Design and research in the laboratory, and in In 1998, the NIH introduced the Clinical preclinical studies, to the development of Evaluate Translational Research Research Curriculum Award to “improve trials and studies in humans. The second Programs the quality of training in clinical area of translation concerns research As members of the ACRT Evaluation 7 aimed at enhancing the adoption of best research.” Over 50 training programs Committee, our goal was to develop a were funded through this award, and practices in the community. Cost- effectiveness of prevention and treatment framework to assess translational many of these programs grant degrees in strategies is also an important part of research programs. We quickly realized, clinical research. translational science.9 however, that disagreements over what is and is not included in the definition of The NIH’s definition of clinical research According to this definition, translational translational research would make it has been widely accepted by institutions research is part of a unidirectional difficult for us to define competency and programs and provides a common continuum in which research findings are requirements and determine whether basis for the NIH-funded clinical moved from the researcher’s bench to the these requirements were being met. We research training programs. The patient’s bedside and community. In the therefore began discussing the definitions definition has facilitated cross-program continuum, the first stage of translational outlined above. We also consulted efforts to identify core competencies, best research (T1) transfers knowledge from articles published on the topic of practices, and meaningful outcomes that basic research to clinical research, and the translational research8,10,11,13,14 and data are relevant across the broad spectrum of second stage (T2) transfers findings from provided on the Web sites of the first 12 training in clinical research. This, in turn, clinical studies or clinical trials to practice CTSA recipients.15 has allowed program evaluators to settings and communities, where the develop useful assessment metrics to findings improve health. Working definitions document the success of training programs. In a commentary published in 2008, We developed the following working Steven Woolf10(p211) pointed out that definition of translational research: Today, about 30% of the NIH budget is “translational research means different spent on clinical research.5 However, Translational research fosters the things to different people” and argued multidirectional integration of basic some believe that this figure includes that the different types of translational research, patient-oriented research, and studies of animal models, in which case research are too narrowly defined. In population-based research, with the long- the actual support for clinical research particular, he argued that if T2 research is term aim of improving the health of the would be much less.5 going to result in the knowledge needed public. T1 research expedites the to improve health and the quality of life, movement between basic research and patient-oriented research that leads to Definitions of Translational then T1 research must include sciences new or improved scientific understanding Research related to populations (e.g., or standards of care. T2 research epidemiology, psychology, economics, facilitates the movement between patient- The definition of translational research is and behavioral sciences).10 oriented research and population-based less clear than the definitions of basic and research that leads to better patient clinical research. When the Institute of Medicine (IOM) outcomes, the implementation of best convened the Clinical Research practices, and improved health status in Although a Medline search indicates that Roundtable, the roundtable group communities. T3 research promotes the term translational research appeared interaction between laboratory-based developed a model for translational research and population-based research as early as 1993, there were relatively few research that was highly aligned with the to stimulate a robust scientific references to this term in the medical NIH definition.11 understanding of human health and literature during the 1990s, and most disease. references were to research about cancer. Like the NIH and the IOM, the At the time, the literature on cancer Translational Research Working Group We believe that when T1 is tended to use the term translational of the National Cancer Institute included conceptualized as the process of moving research to refer to work spanning both basic and clinical research in the T1 from bench to bedside, it represents a different types of research (e.g., segment of the continuum: movement toward the goal of improved immunology studies spanning basic and “Translational research transforms health. It may evoke the image of a clinical research) or work spanning scientific discoveries arising from patient receiving medical care or the disciplines within a particular type of laboratory, clinical, or population studies image of a healthy individual benefiting research (e.g., bench research involving into clinical applications to reduce cancer from improvements in health care or

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many possible models of training that can provide the academic path to these goals.

Training in translational research will vary depending on the background of trainees and the areas of research they plan to pursue. Given the diversity of educational backgrounds and research interests, it will be necessary to design a customized curriculum for almost every trainee. To ensure an understanding of complementary disciplines and to enhance communication and collaboration, trainees who have focused on basic laboratory research will need to become immersed in clinical sciences and clinical practice, whereas trainees with a Figure 1 Model for translational research, as proposed by the Evaluation Committee of the Association for Clinical Research Training. clinical focus will need to gain exposure to basic science research. Both types of individuals will also benefit from training public health. Alternatively, it may potential to directly affect clinical in population-based sciences, as is suggest that patient-oriented research practice. We use the term population- encouraged, for example, by the (research at the bedside) is a key step based research to refer to studies involving Burroughs Wellcome Fund, which toward improvement in the treatment or epidemiology, social and behavioral sponsors the Institutional Program prevention of disease. sciences, public health, quality Unifying Population and Laboratory evaluation, and cost-effectiveness. Based Sciences.17 The model that we propose (see Figure 1) captures the dynamic interplay inherent In our model, the T1, T2, and T3 arrows The details of a clinical immersion in the concept of translational research. represent bridges from one type of experience will depend on the area of The model’s circular structure suggests research to another. Examples of T1 research interest. For example, trainees that research is a continuing cycle, and its research are drug development, interested in neuroscience may wish to bidirectional arrows emphasize that new pharmacogenomics, and some studies of accompany clinicians in a psychiatry or knowledge and hypotheses are generated disease mechanisms and research into neurology clinic, and trainees working on at each step. Some basic research and new areas such as genetics, genomics, and bone tissue regeneration may participate population-based research is translational, proteomics. Examples of T2 are clinical in the activities of a clinical orthopedic but neither type of research is by epidemiology, health services (outcomes) surgery program. Trainees seeking definition translational. In contrast, research, and the newly developing laboratory immersion could take courses patient-oriented research fundamentally methodology of community-based in techniques of molecular biology or addresses issues that have the potential participatory research. Examples of T3 genetics and work at the bench for a to translate to clinical practice and, are emerging disciplines such as concentrated period of three to four therefore, affect health. For these reasons, molecular and genetic epidemiology. T3 months. Trainees who have a background the model includes only part of basic research highlights, for instance, how in the social sciences or economics and research and population-based research research in populations informs are interested in health services research within the circular structure but includes hypotheses that can be tested in basic may need to join a team of investigators all of patient-oriented research within science laboratories and how biomarkers working in their area of interest. this structure. in animal models can translate into population-based screening tools. All trainees could benefit from The concept of basic research, as defined fundamental instruction concerning earlier, is generally well understood. The study design, data collection, statistical concepts of patient-oriented research and Implications for the design of training analysis, ethics and research integrity, population-based research fall within the programs protection of human subjects, the search broader rubric of clinical research as The interaction of several disciplines is for funding sources, the writing of defined by the NIH. We use the term required to translate knowledge from one institutional review board protocols and patient-oriented research to refer to type of research to another (e.g., to move grant applications, the pursuit of patents studies that include groups of patients or a basic science discovery to the bedside). and technology transfer, and government healthy individuals and that are designed Collaboration among disciplines through requirements for new drugs and devices. to understand the mechanisms of disease multidisciplinary teams facilitates the Because of the nature of translational and health, to determine the effects of a emergence of novel concepts and research, it is also imperative for training treatment, or to provide a decision approaches to addressing important programs to ensure that trainees develop analysis of the care trajectories of health issues. The emergence and the competencies needed to thrive in a patients.16 Clinical trials are an example development of new ideas are goals of multidisciplinary collaborative team. of patient-oriented research that has the translational research, and there are These competencies include

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List 1 Logic Model for Training in Translational Research

Intermediate-Term Long-Term Short-Term Outcomes Outcomes (Practice Outcomes Inputs Activities Outputs (Training Changes) Changes) (Impact) Financial inputs: institutional investments; tuition; National Institutes of Health funding Didactic coursework Well-trained and well- Increased satisfaction of Effective translational Increased of trainees (T32, Clinical and about research methods, mentored translational trainees. research studies conducted national capacity Translational Science Award, epidemiology, researchers working in a in a multidisciplinary for translational etc.); and other federal and biostatistics, research collaborative, participatory, environment. research. private funding of trainees. management, ethics, multidisciplinary Increased satisfaction of basic science, scientific environment and linking faculty, program communication, and bench, bedside, and administrators, and Effective use of human Improved Human resources: trainees community engagement. community-based resources mentors. subjects in clinical human health (clinicians and bench in a cyclical process. translational research trials. status indicators. scientists); program faculty and administrators; mentors Mentored clinical Effective translational (clinical researchers, bench research, including Innovative thinking and research studies designed Cross-disciplinary research scientists, geneticists, scholarly writing, problem solving. in collaboration with teams managed in a biomedical engineers, social presentation, and multidisciplinary collaborative and scientists, and behavioral publication of results. colleagues. participatory manner. researchers).

Cross-disciplinary research Relevant ethical and legal Research manuscripts collaborations. issues considered during submitted for publication in the design and peer-reviewed research implementation of clinical journals. Practicums in community research. academic partnerships.

Competitive grant proposals prepared for translational research funding. communication and negotiation skills as students how to think critically,19 the “emotional intelligence” and other skills well as ethical and humanitarian attitudes. truth is, as Jerome Groopman20 points that are not usually taught in research out, that the older generation of students training programs. When we think of The most effective approach would be to were not taught to think as clinicians. innovation and creative problem solving, design an individualized curriculum for Although recent emphasis has shifted to we often look to engineers and designers each trainee, guided by a customized, training medical students and residents to learn about these processes.23 learner-centered advisory committee that how to follow preset algorithms and Similarly, when we think of management, includes mentors with various and decision trees, these approaches are we often look to the corporate sector. A complementary backgrounds in clinical challenging when clinicians need to think useful approach to creating a supportive practice and basic and clinical research. outside their domains.20 Because clinical environment that fosters critical thinking One of the mentors would assume the and translational research in this century and leadership and management skills role of primary mentor to ensure necessitates out-of-the-box thinking, must include the explicit training of coordination of efforts and the success of training programs must teach young fellows and junior faculty in these areas. the mentoring process. researchers how to excel as critical thinkers. Mentoring is a demanding but highly An effective training program in rewarding enterprise whose success Historically, medicine has taken a hands- translational research must use depends on the widely varying skills, off approach to teaching management traditional curricular elements in new needs, and attitudes of different and leadership, the notion being that ways to ensure understanding across individuals.18 Mentors who are able to learning how to manage and lead is disciplines. In addition, it must create monitor the incorporation and simply intuitive. “Something about and use new curricular elements and understanding of translational research management looks so easy that we . . . approaches to ensure that its trainees are essentials will be crucial to the positive never doubt that we could succeed where able to do the following: critically outcomes of training programs. others repeatedly fail,” says Thomas examine the research process, think “out However, trainees will also need to have Teal,21(p3–4) former senior editor of the of the box” to develop ways to impact critical-thinking skills and practical Harvard Business Review. Because health care by transferring knowledge knowledge about how to work managing is less a series of technical tasks from and to the bench, bedside, and collaboratively and manage teams. and more a set of human interactions, community, engage in multidisciplinary Although most medical schools now managers and team leaders require what collaboration, understand successful realize the importance of teaching their Daniel Goleman and his colleagues22 call approaches to community engagement,

Academic Medicine, Vol. 85, No. 3 / March 2010 473 Clinical and Translational Research and develop appropriate techniques to to fulfillment of preestablished Dr. Schteingart is professor, Department of manage multidisciplinary research teams competency requirements, (2) evidence Internal Medicine, Division of Metabolism, in the future. Using multidisciplinary of improvement over time in the trainees’ Endocrinology and Diabetes, and codirector, Education, Mentoring and Career Development skills, the translational researcher will be knowledge and skills regarding Core, Michigan Institute for Clinical and Health able to think and perform in an translational research topics and Research, University of Michigan, Ann Arbor, Michigan. integrated interdisciplinary manner and endeavors, as assessed via testing and via Dr. Marantz is associate dean for clinical research become a new type of investigator. evaluations provided by scientific education and professor, Department of advisory committees, (3) evidence of Epidemiology and Population Health, Albert Einstein Meeting these goals is a challenge because successful career development, as College of Medicine and Montefiore Medical Center, Bronx, New York. research training programs are not measured by the ability to publish articles traditionally content based. We need to in peer-reviewed journals, to obtain Dr. Anderson is professor, Department of consider the creation of a community of Preventive Medicine and Community Health, research grants and academic University of Texas Medical Branch, Galveston, Texas. learners and leaders by fostering the use appointments, and to gain leadership of problem-based learning24,25 as a positions in multidisciplinary teams, and Dr. Platt is executive director, Scholars in Clinical Science Program, Harvard Catalyst/The Harvard gateway to collaborative leadership. (4) evidence of the increased impact of Clinical and Translational Science Center, Harvard Adopting these techniques will require a the program at the institutional level and Medical School, Tosteson Medical Education Center, change in the culture in medical schools, the national level, as judged by whether Boston, Massachusetts. but the time is right to begin the process more translational research is funded and Dr. Baez is professor, Departments of of this cultural shift if we wish to take a conducted at these levels. Pharmacology and Otolaryngology–Head and Neck leap forward in enhancing the practice of Surgery, University of Puerto Rico School of Medicine, San Juan, Puerto Rico. moving from bench to bedside to community Conclusion and back in translational research. Dr. Esposito is assistant professor of clinical We believe that translational research psychiatry, Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of An approach to evaluation moves in a bidirectional manner from Miami, Miami, Florida. one type of research to another—from With the necessity of customizing training Acknowledgments:The authors wish to in translational research, the approach to basic research to patient-oriented research, to population-based research, acknowledge the members of the Evaluation evaluation must be flexible. One of the Committee of the Association for Clinical most flexible approaches is to design a logic and back—and involves collaboration Research Training, especially Sunday Clark, ScD model that offers a graphic display of the among scientists from multiple (University of Pittsburgh), Yvonne Belanger, MS relationships between program elements, disciplines. The design of an effective (Duke University), David Goff, MD, PhD (Wake training program in translational Forest University), and Jan Hogle, PhD objectives, and desired outcomes in the (University of Wisconsin). short term, intermediate term, and long research is a challenge because the term. The accompanying logic model (List program must offer each of its trainees Funding/Support: This research was supported by 1) provides an example of a framework for the opportunity to master a combination National Institutes of Health grants awarded to of skills that are not taught together in the University of Pittsburgh (UL1 RR024153), a training program in translational Duke University School of Medicine (UL1 research. The logic model approach has the traditional training programs. The approach to evaluating the success of RR024128), Albert Einstein College of Medicine advantage of being adaptable as definitions (UL1 RR025750), Harvard Medical School (K30 of research and research goals evolve. translational training programs must be RR022292), and University of Wisconsin (UL1 Specific elements in the model can change, flexible enough to accommodate the RR025011). needs of individual institutions and along with indicators and data sources, Other disclosures: None. without completely disrupting the overall individual trainees within the logical flow of objectives. institutions, but it must also be rigorous Ethical approval: Not applicable. enough to document that the program is In the logic model for a translational meeting its short-, intermediate-, and References research program, the domains to be long-term objectives and that its trainees evaluated could include (1) whether the are meeting preestablished competency 1 Clinical and Translational Science Awards. requirements. 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