Mentored Research Project
Although coursework and other didactic sessions are extremely important, actual conduct of clinical research is the foundation of research training. We have found that the project is most valuable when the fellow is involved all aspects of the study including conception of the study, study design, data collection, data analysis and interpretation, presentation of the data in oral and written forms, and formulation and initiation of new research studies based the findings of the original study.
The mentored research experience extends over the entire two years of research training. During the first three to six months, the fellow works with the mentor to conceive and design the clinical research project, write the proposal, obtain IRB approval, and design data collection instruments, case report forms, recruitment materials, and other elements needed to initiate the study. Whenever appropriate, the applicant and mentor use the Boston University General Clinical Research Center and Dr. Cupples, the Program Statistician. The fellow prepares a budget, including detailed justification for the use of funds from the Vascular Medicine Clinical Research Training Program and confirm the availability of other funds needed to complete the project.
The career mentor, advisory committee, and Program Leadership review the protocol to ensure that it is feasible, scientifically sound, and appropriate as a training experience for a fellow. Based on this review, the fellow and mentor revise or refine the protocol and obtain final approval. The protocol is then submitted for IRB approval and further revised, as necessary. During this review process and while awaiting IRB approval, the fellow plays a collaborative role in other relevant research projects in the laboratory to gain experience with methodology and gain an understanding of the conduct of research, policies and procedures, functioning of the investigational pharmacy, and other practical aspects of conducting clinical research at the Boston University Medical Campus. When appropriate and feasible, the fellow is asked to write a review article, which directly relates to the proposed research and serves to provide the fellow with an in-depth review of the relevant scientific literature.
Once IRB has approved the protocol, the fellow is responsible for all aspects of the study including subject recruitment, data collection and tabulation. When recruitment is completed, the fellow works with the research mentor and program statisticians in the analysis and interpretation of the data. By the middle of the second year, we anticipate that data collection and analysis will be completed. The candidates have several opportunities to present their findings including the CREST Seminar and Evan’s Week, which is an annual research program and abstract competition sponsored by the Department of Medicine. In addition, it is expected that the work will be submitted for presentation at a national meeting and publication in a peer-reviewed journal. Finally, each fellow writes and submits a manuscript by the end of the training period and uses the initial findings as preliminary data for their grant application.
The Research mentor monitors the progress toward this goal and assists with the research project on a day-to-day basis. The fellow and research mentor prepare a progress report every six months that is reviewed by the Program Mentor, the Advisory Committee, and the Program Leadership. If there is evidence of a problem, the monitoring frequency is increased to a monthly report until the issue is resolved.