Gordon R. Bernard, M.D., serves as the VICTR/CTSA Program Director and is responsible for providing oversight and governance for VICTR and the CTSA. As Program Director, Dr. Bernard is responsible for oversight of all VICTR/CTSA programs and activities.
Education, Training and Career Development Program:
Nancy J. Brown, M.D., serves as one of 7 VICTR Co-Program Directors with direct oversight of the “Education, Training and Career Development” program of the CTSA”. The primary objective of this program is to promote the recruitment, training, advancement and retention of new investigators in clinical and translational science careers.
Vanderbilt University Medical Center (VUMC) has a long and distinguished history of advancing the science and practice of medicine and preparing scholars for clinical and translational research. The Medical Center’s 44 NIH institutional training grants and training grants funded through other federal agencies attest to the breadth, skill, and commitment of our faculty to developing future leaders in clinical investigation. The Vanderbilt Clinical Research Center (CRC), one of the oldest and largest in the country, has been an important training ground for many of our nation’s leading clinical and translational researchers.
In 1999, Vanderbilt obtained K30 funding to create a formal curriculum for the multi-disciplinary research training of clinical investigators at VUMC. That funding resulted in a new degree program—the Master of Science in Clinical Investigation (MSCI)—for training clinical researchers in translational research, including mechanisms of human disease, therapeutic interventions, clinical trials, and the development of new technologies. The K30 award also allowed the expansion of the existing Vanderbilt Master of Public Health (MPH) program for clinical investigators directed toward epidemiologic/behavioral research or outcomes/health services research and the translation of medical discoveries into practice.
In the same year, Vanderbilt and Meharry Medical College (MMC), a historically black institution, established the Vanderbilt-Meharry Alliance to promote educational collaboration and increased research in Health Disparities. The Alliance has allowed for the sharing of resources for training clinical and translational scientists. In 2002, this collaboration resulted in R25 funding of the Clinical Research and Career Development program at Meharry.
One year prior to the funding of the K30, Vanderbilt created the Medical Scholars Program (MSP) to allow select medical students to spend one year engaged in focused research. Development of the program in 2004 provided all medical students with a concentrated experience in clinical science or public health promotion. At the same time, Vanderbilt, recognizing the importance of protected time in the development of successful physician-scientists, established the Vanderbilt Physician-Scientist Development Program (VPSD) to provide salary support to newly appointed assistant professor physicians with significant research experience to receive additional mentored investigative training. In 2002, NCRR K12 funding of the Vanderbilt Clinical Research Scholars (VCRS) program provided trainees in clinical and translational science with a similar mentored research apprenticeship integrated with the didactic training of the MSCI and MPH programs.
Each of the existing educational programs will be enhanced through the support of the CTSA. For example, the MSP will be expanded and a new novel track in clinical and translational science will be added as well as a doctoral program in epidemiology. In addition, an integrated multi-disciplinary institutional career development program, The Newman Society, will be enhanced to foster the development of leadership in a multi-disciplinary setting.
New and improved educational programs in continuing education, training and professional development will be implemented including refining continuing education programs in responsible conduct of research and biomedical ethics. Educational efforts will serve not only investigators but others involved in research including nurses and other research staff.
Leonard Bickman, Ph.D., serves as one of 7 VICTR Co-Program Directors with direct oversight of the “Evaluation” program of the CTSA”. The primary purpose of the Evaluation Program is to assess and evaluate how the CTSA is working and how successful it is at achieving its many goals. Dr. Bickman has assembled a team of individuals with expertise in metrics, institutional organization, statistics, and clinical and translational research, and other skills to assist him with the process of evaluation. Dr. Bickman and his team will review all reports of productivity and quality emanating from any component of the CTSA and will report findings to the Executive Committee and the Internal Advisory Committee as well as to the NIH Program Officer directly when deemed appropriate.
Metrics measuring satisfaction of Meharry investigators will be reviewed in aggregate as well as by themselves to ensure resources are being made highly accessible to Meharry. Dr. Bickman will also work closely with the national CTSA Internal Advisory committee to develop rationales for alternative metrics and to determine by consensus process the national standards for regularly reported metrics such that CTSA sites can use these data to help determine best practices.
Participant and Clinical Interaction Resources Program:
David Robertson, M.D., serves as one of 7 VICTR Co-Program Directors with direct oversight of the “Participant and Clinical Interaction Resources (PCIR)” program of the CTSA”. The PCIR includes physical space, personnel, equipment, supplies, facilities, and some of the core facilities within Vanderbilt and Meharry that support clinical research, but also reaches beyond the institution to support investigators conducting community research. It provides infrastructure and resources for inpatient and outpatient research including 24 hour a day nursing space, kitchen facilities and on-site equipment. Both adult and pediatric research studies are supported by the PCIR.
Facilities are available at Vanderbilt Medical Center in the Clinical Research Center, where 21 inpatient beds and 7 outpatient rooms are available. Vanderbilt Children’s Hospital Doctor’s Office Tower houses the Pediatric Clinical Research Center providing dedicated outpatient space and dedicated inpatient and outpatient research nurses to support pediatric research. The Clinical Trials Center, also located at Vanderbilt, provides outpatient space and staffing support on site, but can go where the participant is in an effort to increase the community’s involvement in research.
Quality of care and participant safety and advocacy are the highest priorities of the PCIR. In addition, the PCIR provides a rich environment for the education and training of junior investigators, research nurses and other research personnel in clinical and translational research. The CTSA provides funding for the PCIR resources, exposing investigators to resources not typically available to them in other settings. The availability of these resources stimulates new idea can lead to important discoveries some of which ultimately translate into important treatments or preventive care strategies.
Translating Clinical Discoveries into Practice Program:
Robert Dittus, M.D., M.P.H., serves as one of 7 VICTR Co-Program Directors with direct oversight of the program “Translating Clinical Discoveries into Practice”. The goal of this program is to stimulate and support innovative and clinical, behavioral, epidemiologic, and public health research to accelerate the translation of promising new preventive, diagnostic, therapeutic, and prognostic discoveries from early clinical feasibility, safety, and efficacy testing into effective, patient-centered, safe, timely, efficient, and equitable clinical practice. This program is designed to: provide expert assistance to investigators who are researching new ideas, help investigators identify who might benefit most from their research; assist investigators in testing new drugs and treatments for safety and adverse reactions, examine ways individualized patient-centered care might incorporate patient preferences; eliminate disparities assuring equitable care all appropriate population subgroups and to examine and reduce the behavioral barriers that influence a patient to be compliant and adhere to recommended disease prevention and management strategies.
This program operates through the use of five Clinical and Translational Cores that support and enhance the development, execution, analysis and interpretation of research to assure rigorous clinical research methods are utilized in a core supported research. Investigators schedule a core appointment where they interact with experts in their field of research to assure the studied they design and conduct are the best they can be to have the best chance of being successful. Each of the Cores has a different focus:
a. The Clinical Epidemiology Core stimulates and facilitates clinical effectiveness studies and studies that identify patient and population subgroups at differential health risk that would benefit from care.
b. The Behavioral Research Core stimulates and facilitates behavioral research to make the content and process of care more patient-centered, determine behavioral barriers to and facilitators for recommended health behaviors and healthcare, and develop and test interventions to eliminate behavioral barriers and increase healthy behaviors and adherence to effective healthcare.
c. The Implementation Science Research Core stimulates and facilitates clinical studies that improve the safety, timeliness, equity, efficiency, and cost-effectiveness of care and accelerate the incorporation of evidence-based content of care into real-world settings.
d. The Surveillance Epidemiology Core stimulates and facilitates observational and surveillance studies that will generate and test new hypotheses on disease prevention and monitor the performance of the content and processes of care in the real world.
e. The Community Health Core stimulates and facilitates community-based research, engage the community as research partners to inform research hypotheses, designs, implementations and interpretations, and appropriate dissemination of relevant findings into community practice.
In addition to the Cores, this program also supports investigators through the conduct of Clinical and Translational Design and Analysis Clinics and the Translating Clinical Discoveries into Practices Seminar Series. Pilot funding for translational research is also supported through this program.
Design, Biostatistics, and Research Ethics Program Description:
Frank E. Harrell, Jr., Ph.D. serves as one of 7 VICTR Co-Program Directors with direct oversight of the program “Design, Biostatistics and Research Ethics”. A common problem hindering efficient clinical research nationally is limited communication between physician-scientists and needed experts. This often results in suboptimal collaboration and insufficient understanding of biostatistics and design principles. Fundamental to maximizing the value created by every dollar spent on research is ensuring the rigor and quality of the research itself. To support and strengthen individual clinical and translational research initiatives, we have established the infrastructure, services, and training needed to ensure that rigorous study design is enforced, and that critical methodologic, biostatistical, and ethical principles are regularly and reliably met. This program strives to improve research quality and rigor by broadly implementing and making available a wide range of supportive research both new and experienced researchers from study design and set-up to analysis and publication.
One of the innovative resources available to investigators through this program is the ability to participate in research studios. There are 5 different types of studios (design, implementation, analysis, manuscript and X), each providing a different look at an investigators research plans. A studio is scheduled to include the investigator, the investigator’s mentor/teacher if a young investigator, an experienced moderator, and up to 6 experts, either in the type of studio or the disease process under study or some other component of the research and a biostatistician. Materials are distributed and reviewed prior to the studio and discussed in detail during the studio. Studio’s offer an opportunity for experienced researchers to provide suggestions and critiques of a research plan or the data generated by a study. It also provides an opportunity for investigators to meet and begin collaborations with other experts who share interest in their field of research. Investigators are provided with minutes of the studio for reference. Studios are proving to be a major asset to junior investigators.
This program provides biostatistical consultation including study design, sample size estimation, statistical planning and analysis. The program also provides support for research and improvements in advanced experimental designs, such as adaptive designs, which can make research simultaneously more productive and more ethical. In addition, research on research is a goal of this program. Already this group has developed innovations, including research to measure and improve long-term retention of statistical skills by investigators and developed validation and simulation tools to detect and minimize bias in estimating the effect of treatments, risk factors and biomarkers of disease and outcomes. Lastly, but as important, this program provides ethical consultation to assist investigators in approaching and appropriately handling the ethical challenges that can arise throughout the research process. As appropriate, ethicists are invited to participate in research studios.
Biomedical Informatics Program
Dan Masys, M.D. serves as one of 7 VICTR Co-Program Directors with direct oversight of the program “Biomedical Informatics “. Dr. Masys is responsible for the development and evaluation of the advanced systems and technologies that support basic and biomedical research, clinical research, health professions education and patient care. A common theme of the work of the CTSA is the need to compile data, information and knowledge to determine the best course of action. Informatics and knowledge management will be catalytic in improving the effectiveness, consistency, and speed of operations directed at improving research productivity and lowering barriers to translation of basic research findings into clinical testing, and clinical research findings into local and national practice.
This program provides institution wide strategic informatics planning, oversight and authority to implement new informatics systems that affect basic and clinical research and patient care. This program works closely with investigators and administrative staff to develop systems that improve their efficiency and effectiveness. Tools and software developed by this program
Meharry Focused Partnership & Stopping Health Disparities Program Description:
Valerie Montgomery-Rice, M.D. serves as one of 7 VICTR Co-Program Directors with direct oversight of the Meharry Focused Partnership & Stopping Health Disparities Program. Vanderbilt and Meharry have a long-standing collaboration through the Meharry-Vanderbilt Alliance that has brought together the strengths of these two great institutions to learn from each other for the benefit of student education, patient care, and research progress. Their missions are virtually the same: education and research leading to the best patient care. As a result of that successful partnership, Meharry has joined Vanderbilt as a CTSA partner. This initiative provides access to CTSA resources to Meharry investigators. It allows for the sharing of information designed to improve the efficiency and effectiveness of clinical research at both institutions.