A career in clinical research increasingly requires high levels of preparation, training, and commitment similar to a career in laboratory-based research. While it is common for physicians/scientists to dedicate several years of focused effort to master the techniques and strategies required for productive careers in laboratory research, individuals embarking on a career in clinical investigation only recently have had a similar opportunity to develop their skills. This disparity is representative of the lack of structured training programs in clinical research. Recognizing this lack, the NIH has developed the K series of grants. These grants enhance development of investigators with specialized clinical and laboratory skills to use rigorous methods to address research questions with human populations. UCSD has incorporated these concepts in the design of the CREST program, under the direction of Ravindra Mehta, MD. The main features of the program design are as follows.
Integrated Design for State-of-the-Art Training
Three characteristics common to successful training, whether it be in clinical or laboratory research, are: 1) training in research methods applicable to the area of investigation, 2) application of these methods to a state-of-the-art research question, and 3) collaboration with more experienced investigators. Well-trained laboratory researchers benefit from all three training components. Research mentors provide a laboratory environment for instruction in research methods, which the trainee uses in a specific project while also interacting with other investigators in the field. Similarly, experienced clinician investigators utilize the clinic or hospital as a "laboratory" for their research. It is more difficult for clinical researchers to control the "laboratory" environment and provide comprehensive training. We have designed the CREST program to integrate the three components described above. The program requires the scholar to have an independent research project, provides the didactic and practical training required in the methods of clinical research, and creates an environment for the scholar to learn from a multidisciplinary faculty who provide individualized guidance for career development.
Broad-based Curriculum Encompassing Major Areas of Clinical Research
As clinical research is often multidisciplinary and multifaceted, a curriculum for instruction should be representative of the different components of clinical research, as defined by the NIH. Taking this into account we have incorporated all major elements of clinical research in the design of the curriculum. The curriculum is designed with courses given over two years. It is comprised of eight modules which cover the principles of epidemiology, biostatistics, patient-oriented research (two modules each), health services/outcomes research, and data management/informatics (one module each). We believe that the CREST scholar must not only have a strong basis in academic medicine, but must understand the bioscience/biotechnology to be an effective researcher. Consequently, we include professional development seminars that are offered throughout the two years and focused on key elements including grant writing, scientific communication, research management and time management.
Components of CREST Program Curriculum
Each module is given over one academic quarter and is comprised of 10 weekly, 2-hour periods of instruction in the early evening. The format for instruction includes a combination of didactic lectures, group discussions, and hands-on computer-based training. Once-a-week evening classes allow the scholar to focus on his/her primary research and training project with disrupting clinical responsibilities during the major part of the work week. For individuals interested in completing the CREST curriculum in a shorter time period, a one year option is available. This requires both the first and second year courses be taken concurrently on two nights a week (Wednesday and Thursday) e.g. year 1 course on Wednesday and year 2 course on Thursday. However, the sessions must begin with either the Winter session in January or Summer session in July.
Targeted Participants with Track System for Enrollment
The program is primarily directed towards postdoctoral candidates with a M.D. or Ph.D. degree interested in pursuing a career in clinical investigation or translational research. Potential applicants will have a primary research training focus either in basic science or in clinical research. Scholars are recruited from many departments and disciplines and range from graduate students working towards a Masters degree to individuals holding junior faculty appointments. Scholars differ in levels of prior training and experience in areas covered by the curriculum, in levels of commitment, and in interests. In order to accommodate the varying needs we have incorporated two mechanisms to permit flexibility while retaining the benefits of structured modular instruction. First, scholars spend the majority of their time working on their primary focus for training as a basic scientist or a clinician investigator. Second, scholars are able to select from two training tracks for participating in the CREST program to supplement their training. Participants are assessed on application to the program for their goals and needs for training in specific areas.
For those with more limited goals, Track I involves a smaller number of modules. For example, fellows whose interest and training focuses on laboratory research may elect to take only the modules involving biostatistics, career development, and ethical and regulatory issues. Those who pursue Track II commit to the entire eight-module, two-year curriculum. Taking all eight modules is equivalent to approximately 16 credits hours. Track II scholars have the option to enroll in the UCSD Masters of Advanced Studies in Clinical Research anytime during the first year of training and can apply the CREST curriculum credits towards the Masters degree.
A key feature of the program is that it addresses the continuum of learning experienced by the scholar. In addition to the curriculum, each scholar who enrolls in the MAS program is required to have an individual research project supervised by his or her primary research mentor. In addition, each scholar is paired with a CREST faculty member, who serves as a mentor to assist with their individual research project as well a providing career guidance. The CREST faculty interacts with the primary research mentor to ensure that scholars have the appropriate support and protected time to pursue their goals. In order to assign a CREST mentor to each applicant we require the applicant to complete a pre-course assessment form that provides information on content knowledge, needs and learning styles. These instruments are repeated at periodic intervals to track each applicant's progress through the duration of the training program.
UCSD residents, fellows, faculty (including laboratory-based fellows) MUST apply through CREST and pay a discounted fee up to 18 credit units. If interested in earning the CREST certificate and/or transferring to the MAS degree program, you must apply for Track II; if interested in individual courses, you should apply for Track I. The cost for residents and fellows is $268 per unit ($536 per two-unit course) and for faculty it is $375 per unit ($750 per two-unit course). The fee covers the costs for lectures and course materials including books. The fee after completing 18 units and/or transferring to MAS program is $750 PER UNIT($1500 per two-unit course)!
Non-UCSD folks (coming from industry or other academic institutions) must apply through MAS program and pay the regular course fee; i.e., $750 per unit ($1500 per two-unit course) plus the registration fee. Details of the Master’s Degree program and fees can be found at the MAS web site: http://clre.ucsd.edu.