Program History & Mission

History

In July 2001 the University of Utah launched the Training Program in Clinical Investigation (TPCI) a two year didactic curriculum supported by a K-30 award (Clinical Research Curriculum Award) with James P. Kushner, MD as the Principal investigator. The TPCI was supervised by an Executive Oversight Committee consisting of John Hoidal, MD, Matthew Samore, MD, PhD, James Kushner, MD, Carrie Byington, MD, and Lynn Jorde, PhD. The TPCI continued into 2008, when the NIH Clinical and Translational Science Award program awarded support for the University of Utah Center for Clinical and Translation Science (CCTS). The CCTS encompassed the former K30 within its Research Education, Training, and Career Development Program. Also in 2008, the curriculum that evolved from the TPCI became the Master of Science in Clinical Investigation (MSCI), approved by the University of Utah Board of Regents to be awarded by the School of Medicine.

As of January 1, 2013, 36 students have graduated with the MS degree in Clinical Investigation. Further, over 400 other individuals from the University community, including students from other degree programs, faculty, and staff, have improved their clinical research skills by participating in courses from the Clinical Investigation curriculum.

Mission

Purpose of Degree

Well-trained clinical investigators represent a vital resource for the advancement of scientific knowledge and the development of improved treatments for human disease. The goal of the MSCI is to provide superior, coordinated didactic and practical training for individuals interested in academic careers in clinical investigation. The program prepares trainees to be competitive investigators capable of gaining extramural funding for their clinical research projects. The program is designed to prepare the next generation of effective clinical investigators in academic departments and academic medical centers. This degree program addresses the need for research training for individuals seeking careers in academic medicine.

Courses specific to our program carry the designation “MDCRC”, a designation indicating that the General Clinical Research Center (GCRC) is the organization within the School of Medicine sponsoring the courses. Some of the courses in the didactic curriculum are graduate level courses sponsored by other departments, particularly Medical Informatics, Biochemistry and Human Genetics. The MSCI is complementary to a number of NIH-funded training programs in the School of Medicine. These NIH K-12 and T-32 programs support training in specific areas of medicine; the coursework in the MSCI provides the didactic classroom curriculum in research methods required for trainees in these programs. These peer-reviewed programs provide evidence of the existing capacity for providing research training within the University of Utah's School of Medicine.

University of Utah faculty members are principal investigators of more than 200 current investigator-initiated research awards (R01) from the National Institutes of Health in diverse fields, an indication of a thriving environment for biomedical research and of opportunities for mentorship of MSCI students. Trainees in the MSCI benefit from several multi-investigator research programs that are in place at the University of Utah School of Medicine. The Human Molecular Biology and Genetics (HMBG) program, created in 1987 with funds from the Eccles Foundation and from the Lucille P. Markey Charitable Trust, has been a highly successful program that supplies funding and space for young faculty recruits, most whom are physician-scientists with research interests in human molecular biology. The Informatics, Decision Enhancement, and Surveillance (IDEAS) Center, directed by Matthew Samore, M.D. and housed at the Salt Lake Veteran’s Affairs Medical Center, focuses on implementing and evaluating informatics tools and interventions that integrate decision support and surveillance in order to improve outcomes. Integrated Clinical Research Networks are inter-institutional systems established by the NIH to ensure that high-quality clinical studies and trials can be conducted effectively and efficiently. The University of Utah has been selected to participate in three: The Heart Failure Clinical Research (PI: David Bull, MD and Co-PI: Dean Li, MD, PhD) The Stillbirth Research Collaborative Networks (PI: Robert Silver, MD) The Myeloproliferative Diseases Research Network (PI: Josef Prchal, MD). The inclusion of the University of Utah in these networks provide a rich resource for physician-scientists and Ph.D.-scientists to participate in clinical trials of novel diagnostics and therapeutics, and offers access to data throughout these national networks. The Utah Population Database (UPDB) is a unique source of information for genetic and health studies. The UPDB is based on an extensive set of Utah family histories, traced back over generations, in which demographic and medical information of family members are linked can be traced back through pedigrees. This database has been drawn upon for 30 years of groundbreaking genetic research at the University of Utah and continues to be a resource for novel studies. Faculty

The Master’s Degree in Clinical Investigation is awarded by the School of Medicine rather than by a particular department within the School of medicine. The Program is supervised by an Executive Oversight Committee.

Existing faculty in the School of Medicine are well-qualified to conduct both the classroom teaching and research mentoring for this program. Faculty mentors are regular full-time faculty at the School of Medicine and in several other schools and colleges. Most individuals are tenured faculty and have been awarded the appropriate terminal degree for their field and specialty.

Program Need

Studies from the Institutes of Medicine, the National Research Council, the National Academy of Sciences and the NIH have documented deficiencies in the ability of American Medical Schools to produce qualified clinical investigators capable of combining clinical observations with knowledge generated in the laboratory. Opportunities for productive clinical research that have been generated by advances in genetics, molecular biology and epidemiology have not been adequately capitalized upon. Fostering the translation of new discoveries to practical health benefits for the population is a high priority for the NIH. Successful translational research depends upon a bi-directional flow of ideas between basic science laboratories and the clinical environment but impediments to the development of productive research programs have occurred at two stages. The first is translation from basic science discoveries to clinical trials in humans, the “bench-to-bedside” stage. The second is the translation of new knowledge to clinical practice, the “bedside-to-community” stage. These impediments are due in large part to failure to teach the methods required to perform scientifically rigorous clinical research during medical school and post-graduate medical training.

Furthermore, in many academic centers, basic and clinical investigators are housed in separate facilities and have limited opportunities for collaboration. Other obstacles, such as issues of intellectual property and patient confidentiality, have also limited interactions between clinicians, basic scientists, and industry.

Most clinicians, even those with Master Degrees, are not adequately trained in research design and quantitative methods in order to apply or supervise the use of these methods in their own research projects and thus are not able to develop competitive proposals as principal investigators for external grant funding. The MSCI will prepare clinicians for the transition to clinical investigator status.

Program Assessment

The success of the MSCI is evaluated using multiple indicators. The number of new students enrolled each year is an indicator of continued need for the program and of the program's reputation. Course evaluations by students are used to assess success of individual courses and as a basis for continuing to improve the curriculum to meet student needs. The success of the degree program overall is evaluated by monitoring the number of students completing the degree each year, the number of former students awarded research funding for proposals submitted through peer-reviewed, competitive mechanisms, and the progress of former students in their academic careers.