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Mayo Clinic recently launched a new strategic plan campaign with the theme “Creating the Future.” While the theme is intended to inform and energize the entire Mayo enterprise, it resonates especially throughout the Mayo Clinic Center for Translational Science Activities (CTSA).
The Mayo Clinic CTSA was established in 2006 with a first-round Clinical and Translational Science Award from the National Center for Research Resources (NCRR), National Institutes of Health (NIH). In its first 18 months, the CTSA has had a transformative effect on many areas at Mayo Clinic, including the education and career development opportunities for trainees and faculty.
With the wide latitude given under the CTSA initiative, each of the 24 currently-funded institutions has a unique structure and focus. The Mayo Clinic CTSA is organized into four main components: Research Resources, which includes its GCRC and core labs; a Service Center that provides centralized administrative and research study support; a Community Engagement arm that seeks to broaden the diversity of investigators, funders and research participants and engage multiple collaborators in community-based participatory research; and Education Resources, which provides education, training and career development for all study team members, from continuing education and diplomas to postdoctoral degrees. This article will focus on the structure and accomplishments of the Education Resources component, sharing lessons learned that may be of value to other institutions.
The foundation of the CTSA Education Resources was laid in 1999 when Mayo Clinic established the Clinical Research Training Program (CRTP) with the leadership of Dr. Sherine Gabriel and support from a K30 Clinical Research Curriculum Award from the National Heart Lung Blood Institute (NHLBI). The CRTP offered a Postdoctoral Master's Degree or Certificate in Clinical Research. The Master's Degree was a two-year program consisting of course work and a mentored research experience; it included a requirement that the candidate write and defend a thesis. The Certificate was a one-year program consisting of course work and a mentored research experience; it included a requirement that the candidate write a publishable manuscript describing the results of the project. The K30 award consolidated and extended existing course work in epidemiology, biostatistics and clinical research methods to support the Master's Degree and Certificate programs. The CRTP grew quickly and is currently the largest degree program offered by the Mayo Graduate School, with 40–50 candidates enrolling each year.
In 2005, Mayo Clinic received a K12 Roadmap Multidisciplinary Clinical Research Career Development award from the National Institute of Child Health and Development (NICHD). This award provided salary support and research funds to 6–8 M.D. or Ph.D. scholars per year. Most of these scholars completed the CRTP Master's Degree and received additional education and training in leading multidisciplinary research teams.
With receipt of the CTSA award in 2006, both the K30 and K12 programs were “rolled into” the new award. The CRTP continues to grant a Master's Degree or Certificate in Clinical and Translational Science (CTS) and the K12 program has become a KL2 program. The purposes and activities of these programs remain largely the same and continue to form an important education and training core.
Nonetheless, the process of applying for a CTSA award and the post-award transition to the CTSA mechanism gave Mayo Clinic the opportunity to evaluate its programs. The evaluation included some pointed questions, such as: Does our curriculum and program structure encourage a cross-disciplinary mindset? Do our mentored experiences provide the support young investigators need to launch their careers successfully? And most importantly, are we preparing our graduates to lead the research teams of tomorrow?
A thorough assessment of curriculum and program structure revealed that some of the existing program elements were reinforcing the old paradigm of “siloed” research disciplines. However, to “create the future” of medicine and medical research, education efforts must ensure that the next generation of investigators not only have depth in expertise in their primary discipline but can also see the possible connections across and between disciplines to translate research discoveries into real-world treatments.
How does a large academic medical center with a multi-school College of Medicine and a wide-ranging list of stakeholders transition to a new educational paradigm while preserving the best current practices? Mayo Clinic found it requires careful planning, a spirit of innovation and a firm commitment to integration at all levels.
Again led by Dr. Gabriel, the Director of Education Resources and a Co-Investigator for the CTSA, planning for the new direction and structure of Education Resources began long before the day the notice of grant award arrived. In fact, Mayo's grant application for the CTSA award envisioned a reorganization of courses and staff into overarching programs to support learners at three distinct levels (Figure 1): a Predoctoral Program to provide the required Ph.D.-level education as well as clinical research training for medical students; a Postdoctoral Program to house the existing Postdoctoral Master's Degree, Certificate and KL2 career development opportunities; and a Research Management program to provide Associates in Applied Science (AAS)/post-baccalaureate degrees/diplomas and continuing education for study coordinators and other members of study teams.
To meet the ambitious goal of training the next generation of clinical/translational research teams would require expansion in several areas: learner groups; learner curriculum; learning settings; and delivery methods.
Our first priority was to establish a Ph.D. program in Clinical and Translational Science (CTS) for post-baccalaureate and medical school students (see “Expanded Curriculum” below). In addition, we expanded our predoctoral offerings to medical students, who often receive little exposure to the principles and practice of clinical research during their training. A new course, titled Introduction to Clinical Research, is now a required course for first year medical students at Mayo Medical School (MMS) and the University of Puerto Rico School of Medicine (see “Expanded Settings” below).
We view it as equally important to train and equip the allied health staff professionals who will also be a part of the study teams of the future. Mayo has reorganized and expanded its unique AAS and diploma program in Clinical Research Coordination, offered in cooperation with the local community college and the Mayo School of Health Sciences, to include extended field experience for students. CTSA Education Resources is also taking a leading role in developing training and continuing education opportunities for study coordinators and investigators as part of an institutional initiative to strengthen research management skills and practices.
Curriculum development for the new Ph.D. program presented the most immediate challenge. Building on the foundation of our existing Master's degree in clinical research, we created three areas of concentration to allow students to customize their degree: population-based translational science; patient-based translational science; and laboratory-based translational science. We also expanded the curriculum across all programs (predoctoral, postdoctoral and research management) to focus on three additional key topics: 1) expanding foundational skills for translation to include informatics, behavioral science and translational sciences; 2) health disparities and community-based research; and 3) methodologies for improving the science of healthcare delivery. We believe that strengthening investigative teams' skills in these areas will not only speed translation of discovery into clinical research, but will also address the “T2” gap by ensuring that novel treatments actually reach traditionally underserved populations.
The main Mayo Clinic campus is located in Rochester, Minn., a city of about 100,000 located 75 miles from the Minneapolis/St. Paul metropolitan area. While Rochester is growing quickly and becoming increasingly diverse, it is in a decidedly rural setting. To provide scholars and faculty the opportunity to work with the widest range of cultures and populations and to learn from and apply “best practices” to the work we are doing in our own community, Mayo has formed strong collaborations with several other institutions.
We enhanced a long-standing, productive relationship with the University of Puerto Rico School of Medicine (UPRSOM) to expand bi-directional education and training opportunities for students at both institutions. As mentioned above, MMS and UPRSOM both offer the CTSA's Introduction to Clinical Research course, and an exchange program whereby medical students from each school can conduct short research projects at the partner institution. The CTSA provides stipends and research funds, awarded on a competitive basis, to support these projects.
Another key collaborator is the Center for Minority Health (CMH), led by Dr. Stephen Thomas, in the Graduate School of Public Health at the University of Pittsburgh (another institution that received a 2006 NCRR Clinical and Translational Science Award). In 2007, the CMH was designated as a Research Center of Excellence in Minority Health Disparities by the National Center on Minority Health and Health Disparities. In addition to assistance with curriculum development, Mayo has collaborated with CMH to offer an “Urban Immersion” field experience in Pittsburgh, including participation in CMH's innovative community-engagement events and programs, such as “Take a Health Professional to the People Day”1 and the Healthy Black Families Project2. This experience helps participants enhance their “cultural confidence” in building relationships with minority communities.
Finally, as a result of the K12 Award in 2005, Mayo Clinic, the University of Minnesota and the University of Wisconsin-Madison formed the Upper Midwest Consortium (UMC) as a forum to facilitate inter-institutional collaboration in education for scholars and research collaborations between institutions. This year the UMC has expanded to include the Universities of Iowa, Kansas, Nebraska, North and South Dakota.
To accommodate the growing number and diversity of learners served by CTSA Education Resources, we have launched an ambitious effort to provide coursework in an online environment. Two full-time instructional design specialists have developed online versions of the introductory epidemiology and biostatistics courses included in Certificate program, and we plan to expand this effort to include all required courses for the Certificate program in the future. The online certificate will become the centerpiece of education efforts for the emerging Mayo Health System Practice-Based Research Network, which will help physicians in more than 65 communities surrounding Rochester to conduct primary care-focused research as part of their regular practice. While more than 80 percent of these physicians have expressed interest in clinical research, most of them have little or no training in research methods or management. Education and training will be critical to the success of this community engagement activity.
In order to break down the long-standing “silos” of clinical and research disciplines and separately-funded education programs, it was necessary for Education Resources to integrate horizontally across its own programs and committees, vertically with the rest of the CTSA components, and globally with the other education and research entities in the institution.
Prior to the CTSA, the education programs had existed as distinct entities, in part related to the separate funding mechanisms, each with its own administrative support and committee structure. During the planning and post-award phases of the CTSA application, the Education Resources team began an overhaul of the committee structure and administrative staffing model, identifying four cross-cutting functions that are essential to all programs. Several existing committees were integrated to form four cross-cutting committees: curriculum; evaluation; recruitment/communications; and mentoring/faculty development (Figure 1). In addition, three program-oriented committees coordinate the specific activities of the predoctoral, postdoctoral, and research management programs. An executive committee oversees the activities of all of these committees and coordinates interactions and activities with all of the other schools included in the Mayo Clinic College of Medicine.
Like every reform effort, the drive to transform the way clinical research is conducted and its results are translated into practice will die in one generation unless the torch is passed to leaders of the next generation of investigators through effective education and mentoring. Education can lead and drive this transformation, creating experts in new fields and providing the common language for multidisciplinary teams to communicate, collaborate and ultimately integrate. Eighteen months into our efforts in the new CTSA “era,” we continue to strive to identify and implement ways to truly transform our educational programs to achieve this goal.
This publication was made possible by Grant Number 1 UL1 RR024150 from the National Center for Research Resources (NCRR), a component of the National Institutes of Health (NIH), and the NIH Roadmap for Medical Research. Its contents are solely the responsibility of the authors and do not necessarily represent the official view of NCRR or NIH. Information on NCRR is available at http://www.ncrr.nih.gov/. Information on Reengineering the Clinical Research Enterprise can be obtained from http://nihroadmap.nih.gov.