Didactic training in clinical research methods

Didactic training in clinical research methods is provided through a two-year master’s program in clinical research. The Clinical Research Training Program (CRTP) offers a Master of Health Sciences in Clinical Research, awarded by Duke University School of Medicine.

This training program is designed to provide formalized academic training in the quantitative and methodological principles of clinical research. Geared primarily toward clinical fellows and other health professionals who are training for academic careers, the program offers formal courses in research design, research management, and statistical analysis.

The degree requires graded coursework and a research project. The student’s clinical research activities provide the setting and the data for the project, which serves to demonstrate the student’s competence in the use of quantitative methods in clinical research. The program is designed for part-time study, which allows the fellow/faculty to integrate the program’s academic training with his or her clinical training. Detailed information is available online at the CRTP Web site.

Internships

Three 3-6 month internships will provide exposure to a broad array of methods and procedures involved in patient-oriented research and run concurrently with the didactic coursework during the first two years of the MCRSP.

The DTRI rotation consists of experience working with basic and clinical researchers in many areas of translational research.

The DCRI rotation consists of mentored experience in the conduct of multi-center trials including phase II, III, and IV study design and study management throughout the trial.

The DCCR rotation consists of working with the community to identify health concerns and solutions for health related problems.

The DCRU rotation consists of experience working with early phase clinical research. Included in this rotation is preparation and participation in six Institutional Review Board (IRB) meetings over a twelve month period as a voting member.

Mentored research

Beginning as early as the first year and continuing for up to five years (but no less than three years), each trainee will pursue one of the following Research Tracks under the guidance of a Mentor and/or Lead Mentor:

• Bench to bedside — Trainees in this area will work primarily in the Duke Translational Research Institute (DTRI) environment. Knowledge of basic science is required but will be focused on early clinical applications. Research work will often require access to advanced imaging technologies, analyses performed on human blood, cells or tissue samples, and a high intensity nursing environment for complex human studies. Lead Mentors: Joseph St. Geme, III, MD, Professor and Chair of the Department of Pediatrics; Rebecca Buckley, MD, Professor of Pediatrics; and Victor Dzau, MD, Chancellor for Health Affairs.
• Bedside to bench — Investigations in this area are conducted largely in a wet lab environment but are explicitly driven by insights and questions generated from prior patient-oriented research. For a trainee in this program to elect this track for his or her research, there must be an explicit plan to return to the patient care setting with the insights generated in the laboratory to complete the research program. Investigators require advanced understanding of disease mechanisms and need convenient access to core resources such as confocal microscopy, mass spectroscopy, and transgenic facilities. Research may involve specimens from human subjects but is likely also to involve cellular and animal models. Lead Mentors: R. Sanders Williams, MD, Senior Vice Chancellor for Academic Affairs at the School of Medicine; and Nancy Andrews, MD, PhD, Dean of the School of Medicine.
• Genomics — Trainees in this area may follow either of the bedside to bench or bench to bedside pathways but will have a special focus on the elucidation of the genetic basis of disease and the manner in which knowledge of human genotypes will influence strategies for disease prevention and management. Investigators need access to high throughput sequencing and allelotyping technologies, gene expression and proteomic profiling technologies, DNA and tissue repositories, and advanced database management and statistical support. Lead Mentors: Geoffrey S. Ginsburg, MD, PhD, Professor of Medicine; and Bruce Sullenger, PhD, Professor of Experimental Surgery.
• Clinical trials — Trainees electing to work in this track need specific knowledge of clinical trial design, data management, statistics, regulatory issues, and contracting with sponsors as well as access to an organization that can manage the complex operations required for both small- and large-scale trials. Lead Mentors: Robert Califf, MD, Professor of Medicine and Robert Harrington MD, Professor of Medicine.
• Outcomes/health policy — Trainees in this area require access to operational capabilities for large-scale observational research studies; ability to assess quality of life and economic outcomes; and skill to forge productive relationships with experts in health economics, public policy, law, and business. Lead Mentors: Daniel Mark, MD, Professor of Medicine; Eugene Oddone, MD, Professor of Medicine; and Harvey Cohen, MD, Chair of the Department of Medicine.

Because of the diverse nature of many clinical investigations, mentors representing several disciplines will be encouraged.

Responsible conduct of research

To satisfy requirements for training in the responsible conduct of research, trainees will pursue two parallel tracks in this area:

• An annual five session didactic/seminar study track in accordance with the format suggested by the American Association of Medical Colleges Committee on Misconduct and Conflict of Interest in Research overseen by the Duke Center for Bioethics
• A series of web-based modules provided by the Collaborative Institutional Training Initiative (CITI) that review the ethical principles upon which current regulations are based and endorsed by the National Institutes of Health.