Clinical research is medical research that involves people like you. Translational research is research that applies discoveries generated in the laboratory to studies in humans bench to bedside , or that speeds the adoption of best practices into community settings bedside to practice.
Breadcrumb Home Initiatives Translational Research. People also ask Are clinical trials translational research? What is the difference between applied and translational research? What is the goal of translational research? These learning outcomes, in combination with conditions that supported alumni's engagement in translational activities, such as supportive professional partners, opportunities to network or collaborate, and a translational work environment, contributed to the large number of alumni that were able to engage in translational activities.
Although some waste in research is inevitable, the real concern is that a large part of this waste is due to structural issues in the research ecosystem and could be avoided 3 — 5. The cause of this problem is multidimensional and crosses the domains of academia, industry, and government 6 , 7.
Indeed, academic, commercial, and political interests often influence decisions about what is studied and how this research is executed, while users of research evidence, such as patients and clinicians, are rarely involved in these decisions 4. To better align biomedical research with clinical needs and allow for translation of discoveries to clinical practice, there is a need for improved collaboration between all disciplines that are part of the translational process 4 , 6 This requires central figures with a full understanding of the translational spectrum, who are able to integrate the perspectives and needs of all involved.
These translational scientists—either PhDs with an interest in clinical research or clinician-scientists—need to have a broad set of knowledge and skills to help breaking down the barriers between the different disciplines and foster interdisciplinary communication and collaboration 8 — However, obtaining both a clinical and research degree does not necessarily create a physician-scientist, as clinical and research degrees are based on approaches that are fundamentally different Many dual-degree programs lack integration of these different ways of thinking.
Often, the full breadth of translational medicine, the perspectives of academia, industry, government, and patients, and the skills needed to work in multidisciplinary teams are not addressed. In addition to dual-degree programs there is a wealth of postgraduate training programs that focus their content on knowledge of translational medicine. The majority of these programs do not address the full range of competencies needed to become a lead figure in translational medicine.
They often focus on a more specific skills set, such as postgraduate research training for clinicians or programs that focus on biomedical technology 10 , 12 , Most programs lack role modeling and mentorship 11 , Although mentorship for medical students is generally deemed important, students aiming for a translational scientist career are particularly in need of role models and mentors, because of the many challenges they need to face during their careers It is often difficult to find a clinical job that allows for protected time for research, and funding and reward systems focus on publications and citation scores while translational research consists of longer periods that produce no or only lower-impact papers Because of these challenges in the training and career pathways for translational scientists, the number of researchers and clinicians pursuing such a career has been static over the past decades, with an average age that continues to rise.
All in all, regardless of the need for a growing number of translational scientists to advance medicine, this professional figure seems to be in danger of becoming extinct 16 , The Eureka institute aims to build an interdisciplinary community of translational professionals that are equipped to promote the development of true translational studies.
The international certificate course that is organized on a yearly basis addresses the educational needs of Eureka's mission. During the course, participants are educated in knowledge domains of translational medicine through formal e.
Course evaluations directly after the course revealed high scores for both formal and informal curriculum elements. The present study aims to investigate whether alumni of the Eureka certificate course are indeed better able to engage in translational research activities and how this can be supported.
The research questions are: 1 Are alumni of the Eureka certificate course better able to engage in translational activities? The learning outcomes of the Eureka certificate course were expected to be complex in nature because the course curriculum covers various types of knowledge, for instance explicit knowledge regarding the health professions and personal knowledge of partly tacit nature.
Further, the course builds forward on prior training and work experiences of the participants and combines knowledge and skills development. Therefore, personal professional theory PPT was used to understand the learning outcomes for Eureka alumni. The PPT concept was investigated by Schaap et al. Schaap et al. The content of PPTs involves propositional knowledge, conceptual knowledge and personal beliefs. Propositional knowledge consists of discipline-based theories and concepts Conceptual knowledge contains knowledge about facts, concepts and principles that can be applied in a specific domain.
Personal knowledge is what an individual knows and is able to do PPTs can act as a frame of reference through which new knowledge and beliefs can be acquired and interpreted and direct professional behavior.
The content of a PPT is divided into six objects: vocational domain, organizations, social environment, target group, technical-instrumental processes, and professional development. Together, these objects encompass the vocational knowledge, including knowledge on the professional environment and professional development, that is needed to perform adequately in a specific vocation This means that translational scientists need to have a comprehensive understanding of the aspects of the translational process, including molecular medicine, intellectual property, financing, regulation, and pre-clinical and clinical studies, without necessarily being a specialist in any of those fields.
Knowledge and beliefs of these different domains and disciplines are acquired during the certificate course through seminars, workshops, and case-studies that are facilitated by leaders in translational medicine and educational experts. As it remains impossible for one single person to be an expert of all aspects of the translational itinerary, the course also largely focuses on developing the skills to navigate this itinerary, namely communication, networking, and connecting the different domains and disciplines.
Teambuilding activities and group assignments are designed to develop the skills to foster innovative teams, critical thinking, problem solving, and communicating effectively across broad audiences.
Furthermore, the Eureka course has a personalized learning approach in which challenges and experiences of the participants are central in all sessions. Mentoring and speed-dating sessions with faculty are focused to provide individual advice on issues the participant raises from their working environment or related to career development. The Eureka certificate course was first organized in and aims at mid-level career professionals who are working in the field of translational medicine.
It is organized on an annual basis for an international group of around 30 participants and lasts 1 week. For the present study, all alumni who attended the certificate course from up to and including were approached alumni in total.
An explanatory, mixed-methods design was selected and conducted in two phases In the first phase a questionnaire was distributed among all alumni of the Eureka certificate course. A questionnaire was chosen as the preferred method in the first phase because it would provide quantitative data on the number of alumni that indicated that their participation in the course had helped them to engage in translational activities.
The responses to this questionnaire informed the development of a semi-structured interview guide and coding schemes for the second phase of this study. The interview approach was chosen to gain a better understanding of the conditions for change that hampered or supported the engagement in translational research activities and the learning outcomes for Eureka alumni that impacted their professional activities. From to , participants took part in the Eureka certificate course. In March the questionnaire of the first phase of this study was sent to all alumni.
In October the same alumni were invited over email to participate in a semi-structured interview. In total, 14 alumni 8 male, 6 female volunteered to participate, representing a variety of institutions from four continents.
They were working as either a physician-scientist, full-time scientist, or manager of translational research. Fictitious names are used for quotes throughout this paper to indicate the gender of the alumni.
Two of them BP and NR are experts in the field of translational medicine and one MW is the primary researcher and is not related to the Eureka institute. The questionnaire was pilot tested with five alumni of the Eureka certificate course. The input from these alumni led to minor changes to the wording of the questions. The final questionnaire consisted of the questions: Were you able to apply what you learned at the Eureka course in your home environment?
If yes, what allowed you to? If no, what prevented it? If yes, please explain what changed? The semi-structured interviews were developed by the same three researchers and informed by the results of the questionnaire. The interviews covered 12 questions regarding learning outcomes of the Eureka course, intentions for practice and changes in practice after the Eureka course, conditions for change to engage in translational activities, and questions related to the interviewees engagement in translational networks.
The final questionnaire was distributed via email to alumni who had participated in the course anywhere from 1 to 6 years mean 2. The questionnaire was anonymous and all respondents provided informed consent before starting the questionnaire. The interviews were conducted by one of the researchers MW who is not associated with the Eureka institute, varying from two to seven years after alumni's participation in the course.
Eleven of the 14 interviews were completed using Skype technology and three were conducted face-to-face. All interviews lasted up to 1 h, were audio recorded with the permission of the interviewees and transcribed verbatim without identifying data. The final questionnaire, interview scheme and coding schemes can be found in the Appendix. The transcripts of the semi-structured interviews were coded and analyzed by one of the researchers MW together with a research assistant.
Both were not associated with the Eureka institute. Two coding schemes were developed, using directed content analysis methodology This means that coding schemes were developed before the start of data analysis using prior research coding scheme I or existing theory coding scheme II Coding scheme I regarded the second research question and thus focused on conditions for change that underlie the engagement of Eureka alumni in translational research activities. For the development of this coding scheme the descriptive qualitative responses to the questionnaire were coded, which led to the identification of six conditions for change.
Coding scheme II concerned the third research question. This scheme was developed based on the work of Bakkenes et al. The four categories of learning outcomes in our coding scheme II were: changes in knowledge and beliefs, intentions for practice, changes in practice, and changes in emotions. Each learning outcome category was subdivided into the six objects that form the content of a PPT: vocational domain, organizations, social environment, target group, technical-instrumental processes, and professional development Segmentation was initiated at utterance level After each interview both coders met to compare the results of their coding, resolve differences by consensus discussion, and further develop the coding schemes.
Coding scheme II only required minor changes for clarification in the operationalization of the codes. The final coding schemes were checked for reliability in coding by determining interrater agreement. The final coding schemes were applied to the remaining seven transcripts by the research assistant. Eighty-six percent of the alumni indicated that they had been able to apply what they learned at the Eureka certificate course in their professional home environment.
One aim of the interviews that were held with 14 alumni was to understand the conditions that made it either possible or impossible for Eureka alumni to engage in translational research activities.
This led to the identification of ten conditions for change underlying their engagement in translational activities, which are summarized in Table 1 and will be described in more detail below. For most conditions, both absence and presence of a condition had been experienced by different alumni. Table 1. Conditions for change underlying the engagement in translational research activities of alumni of the Eureka certificate course.
Alumni described how having the opportunity to initiate research projects and collaborations was an important determinant for their ability to engage in translational research. Others, on the contrary, pointed out how they felt restricted to do so within their professional environment.
And I don't think I had any power to change this. The wish to contribute to better patient outcomes was described as a great motivator for almost all of the alumni. Doing research with the patient in mind was said to give additional meaning and relevance to their work and felt more rewarding than research without clinical application.
The importance of being able to contact other people in the field of translational medicine was emphasized by most of the alumni. Examples of experienced benefits were finding a new job through contacts within the alumni's network, knowing more senior translational professionals who can act as mentors, receiving input on research proposals from peers, establishing collaborations for research and educational activities, and being stimulated and inspired by people who share the same objectives.
Some foundations support basic investigators conducting fundamental research in areas relevant to a disease for which they want to provide research funding.
Other organizations are less interested in funding a particular project than they are an investigator who is likely to make an impact. Participants generally agreed that a diversity of approaches, including support for infrastructure and investigators and for targeted and open-ended research, would be important to engaging basic investigators and advancing bench-to-bedside translation.
Academic tenure and promotion policies are one area in which incentives may not be optimal for encouraging basic investigators to develop a translational research program. Tenure-track faculty are required to bring in research funding and make an identifiable intellectual contribution to their fields to gain tenure and promotions, and these contributions are usually measured in research grants and publications.
Moving a discovery through the translational research pipeline often involves team science that may require as many as 30 or 40 collaborators. Tenure, promotion, and appointment committees are challenged to evaluate the importance and impact of the individual contribution a single faculty member makes in the context of a multi-investigator translational project. The existing paradigms used to evaluate basic science faculty, including numbers of grants and publications, are not always sufficient to capture the merits of faculty contributions to the translational research enterprise.
Tenure and promotion committees also may undervalue the contributions of scientists who bring technological expertise to collaborations—such as mass spectrometry experts—even if that technology was key to the experiments and resulting publications.
Moreover, compared to basic science studies, it often takes longer to bring clinical and translational research projects to fruition, resulting in a longer duration between publications, which may disadvantage faculty during their evaluations. Recognizing the shift toward team-based, interdisciplinary, translational science, some institutions have started to explore changes in their tenure and promotions policies and processes to ensure that investigators are recognized for their research contributions.
Adding to these difficulties are challenges scientists face in publishing their translational work. Like study sections and basic science promotion committees, editorial boards and reviewers may place a higher value on hypothesis-driven basic science, making it difficult to publish translational research.
Moreover, journals may not have a mechanism to acknowledge the contributions that each member of a research team makes to the published work. Although journals devoted to translational research may address these concerns, only a few of them exist. More than 50 percent of survey respondents found it difficult to obtain sufficient funding for translational research, navigate human subjects protections regulations, obtain the skills necessary for developing drugs and devices, and access clinical samples.
Obtaining didactic and experiential training, being recognized for team-based research, earning tenure and promotions, as well as communicating across disciplines and identifying collaborators also were cited by many respondents as being difficult.
The survey also revealed that translational investigators found it less difficult to overcome certain barriers than respondents who had not participated in translational research perceived it to be. Compared to respondents without translational research experience, translational investigators found it less difficult to obtain clinical samples and other necessary resources; obtain guidance, mentorship, skills, and training; identify collaborators; and identify the health relevance of their research.
It may be that establishing a translational research program is less difficult than investigators perceive it to be or that those who encounter difficulties ultimately decide not to pursue this line of inquiry.
Whatever the explanation, reducing the barriers will likely encourage more basic scientists to explore the translational potential of their work. There is much that investigators, institutions, professional societies, publishers, and funding institutions can do to support and facilitate the involvement of basic scientists in translational research: creating more training opportunities, reforming recognition and reward policies, fostering collaborations, and providing diverse and flexible forms of financial support will help.
See Additional file 5 for a list of resources. But in addition to creating optimal research and training environments, we must ensure that there are basic investigators who want to pursue translational science.
The research community should explore ways to spark interest in translation among trainees and established investigators who may not have considered how they could apply their own interest and expertise in basic biological science to meet public health needs. All of these efforts will require leaders who are willing to take risks, create new funding models and reward systems, and provide enhanced environments for science education, training, and collaboration.
The first steps in facilitating the participation of basic scientists in translational research are to spark their interest in advancing the health applications of their work and help them cultivate their ability to do so. High school and undergraduate students should be made aware of potential career paths in translation, interested graduate and postdoctoral scientists should be engaged early in their careers, and all investigators should have opportunities to acquire relevant experiential and didactic training.
It is recommended that institutions, funding organizations, and professional societies work together to:. If basic investigators are to play a meaningful role in translating their discoveries into health applications, then they must have opportunities to interact with clinical investigators, clinicians, and industry partners as well as investigators from other disciplines.
They also need access to the tools and resources necessary to conduct translational science. For example,. Incentives are needed to encourage and support basic scientists interested in pursuing translational research. Institutional retention, promotion, and tenure policies and publishing policies should be modified to ensure that investigators are recognized and rewarded for the contributions that they make to translational science. They should define the intellectual space or spaces in which they are going to be leaders, especially if translational science is to be important in achieving tenure.
Public and private funders of biomedical research play a key role in encouraging the entry of basic scientists into translational research. Funders provide direct research support, access to research resources and equipment, and support for the development of training programs. Funding policies and incentives also can motivate the institutional changes needed to support basic investigators. Together, organizations that support translational research have a wealth of information about the efficacy of various programs and policies that could be used to optimize the enterprise going forward.
To attract basic scientists to translational research, it is recommended that funding agencies:. Similarly, provide supplements to clinical investigators to conduct laboratory work based on clinical findings. Basic science is the foundation of medical advancement.
Investigators with a deep understanding of fundamental biology and the mechanisms of disease are essential for translating laboratory discoveries into new and improved health interventions, diagnostics, and treatments. Additional training, resources, and support would enable basic scientists to move their discoveries forward effectively and efficiently. The research community should expand translational research training opportunities for basic researchers and trainees; facilitate their access to the funding, equipment, infrastructure, and other resources needed for translation; encourage and support collaboration between basic and clinical investigators across research disciplines and sectors; and recognize and reward basic scientists for the contributions that they make to this growing field.
Implementing these recommendations will require action by research institutions and funders, scientific publishers, professional societies, and investigators themselves. Scientific societies such as FASEB and the many disciplinary societies representing biomedical researchers have a special role to play in advocating for these changes. We hope that this report will serve as a starting point for moving forward on this important issue.
The symposium and the development and publication of this manuscript were sponsored by the Burroughs Wellcome Fund, the U. JH and AD organized the meeting and prepared the manuscript. KH contributed to the preparation of the manuscript. All authors read and approved the final manuscript. Symposium agenda. Resources list that provides examples of policies, programs, and practices that could facilitate the engagement of basic scientists in translational research.
Barry Coller, Mary C. National Center for Biotechnology Information , U. Journal List J Transl Med v. J Transl Med. Published online Apr Author information Article notes Copyright and License information Disclaimer. Corresponding author. Jennifer A Hobin: gro. Received Feb 24; Accepted Apr This article has been cited by other articles in PMC. Additional file 5 Resources list that provides examples of policies, programs, and practices that could facilitate the engagement of basic scientists in translational research.
Engaging basic scientists in translational research: identifying opportunities, overcoming obstacles Basic scientists are the foundation of the biomedical research enterprise [ 1 ]. The benefits of engaging in translational research The ultimate goal of translational biomedical research is to improve human health—an outcome that benefits all of society. Jude as a junior faculty member nine years ago, he was the head of a basic developmental neurobiology research laboratory.
One day, while deciding how to set up his laboratory space, there was a knock at his door. Two clinicians who treat retinoblastoma patients asked him to spend some time with them in the clinic. He eagerly accepted the opportunity. Dyer knew that Rb gene mutations cause retinoblastoma, a rare childhood cancer with only cases per year in the United States.
But when he asked the clinicians if the tens of thousands of papers available on PubMed on the Rb gene and pathway had any impact on how patients are treated, they replied that they had no impact whatsoever. This surprising response led him to change the direction of his career and the research direction of his laboratory. To Dyer, the reason these basic research papers had not been translated into new therapies was obvious: there was a lack of good animal models for this disease.
Researchers had tried to develop a retinoblastoma model by deleting the Rb gene from the mouse genome, but the manipulation did not cause the mouse to develop retinoblastoma. Unbeknownst to them at the time, another protein, p, is able to compensate for Rb in the mouse. When both Rb and p are deleted from the mouse genome, retinoblastoma develops in about 50 percent of the animals. Using this model, he was able to test different therapeutics against the disease.
In doing so, Dyer applied what he learned from his clinical colleagues about the actual course of treatment in patients i. After going through eight different combinations of drugs and comparing them to the current standard of care, Dyer and his colleagues found a combination that seemed to be better than what children currently were receiving. Jude started a new five-year clinical trial based on those data.
Although going from nothing to a new clinical trial in about 18 months was satisfying, Dyer hoped to do better. He wanted to develop a more targeted chemotherapy that could be delivered locally to the eye and result in fewer side effects. MDMX is amplified in 65 percent of patients and epigenetically turned on in the rest.
Now having a target to go after, Dyer and colleagues developed a model in which the MDMX gene was conditionally over expressed in the mice that develop retinoblastoma. This resulted in a much more aggressive disease in these animals—providing a new model to test chemotherapeutics. This results in virtually percent engraftment with tumors expressing high levels of MDMX. Collaborations with his chemical biology colleagues, who were able to synthesize an MDMX inhibitor, and clinicians, who provided medical information and tumor specimens, enabled Dyer to begin a preclinical trial focused on inhibiting MDMX.
Dyer believes that the process by which basic investigators can translate their discoveries into clinical applications could be emulated at most major medical or academic research centers. The building blocks important for driving translation, such as strong basic science departments, animal research facilities, pharmacology and pathology departments, and clinical trial support are already in place.
He also noted that some translational work can be done with relatively few resources if one acts creatively. He received no support from St. Jude to fund these studies directly. The challenge, he said, is changing the culture. Emphasizing the value of translational research to both basic and clinical scientists, encouraging communications between basic and clinical scientists, mentoring, and understanding the clinical reality of disease progression and therapeutic interventions are all important for increasing participation in translational research and ultimately improving human health.
Open in a separate window. Benefits to institutions Institutions also benefit from creating an environment conductive to translational science. Challenges to engaging basic scientists in translational research Meeting participants noted that numerous challenges can discourage or prevent basic investigators from participating in translational science.
Culture and mindset Basic scientists may see their controlled, hypothesis-driven research as more rigorous than the goal-directed or descriptive research often conducted with humans in clinical research settings. Early in her career, she designed rational inhibitors that could turn off heart cell enzymes one at a time and discovered enzymes that could change the rate at which heart cells in culture beat. She thought this was an important finding that would be of interest to the heart research community, but when she presented her work at a scientific meeting, she found the audience to be disinterested in heart rate regulation.
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