Clinical Investigator Training Program
The two-year Clinical Investigator Training Program is a cooperative effort between Beth Israel Deaconess Medical Center, the Harvard-MIT Division of Health Sciences and Technology. The goal of the fellowship is the training of physicians from a variety of clinical disciplines in the techniques and processes utilized in patient-oriented research. The program is based on a specific curriculum that allows trainees to develop direct experience in the performance of clinical investigation and at the same time, through didactic course work, provides them with a strong foundation in the computational and statistical sciences, biomedical ethics, principles of clinical pharmacology, in vitro and in vivo measurement techniques, and many aspects of the drug development process. The program is funded by an unrestricted educational grant from Pfizer Inc, and Merck & Co., Inc.
Fellows are required to devote at least 80% of their time to the program; the remaining time is allotted to commitments in their sponsoring departments.
Fellows participate in a program with the following elements:
Primary Project
The fellowship is mentor-based and project-oriented. Fellows complete 24 months of laboratory and/or clinical investigation. The research must be patient-oriented and involve direct measurements on patient-derived samples or the use of innovative therapeutic or diagnostic techniques with laboratory-based elements. There must be demonstrable clinical relevance. Use of the outpatient or inpatient facilities of the Clinical Research Center is encouraged. The specific investigation is designed by the fellow under the direct supervision of an established physician-scientist who wishes to apply laboratory research to clinically relevant problems. Where appropriate, a dual mentorship should be considered, including a basic scientist expert in the technology being used and a clinical investigator expert in the condition being studied. The primary project accounts for 80% of the fellow’s commitment to the program.
Core Curriculum
The core curriculum is a required, weekly, seminar and case discussion series covering the essential elements of study design, biostatistics, biomedical ethics, clinical pharmacology, data analysis, specific assay methodologies, and the application of new technologies to clinical and laboratory investigation. The core curriculum stresses problem-solving, utilizing methods introduced in the seminar series and accounts for 20% of the fellow’s commitment to the program.
Elective Curriculum
Trainees have the opportunity to study areas of interest in more depth under the supervision of a specific tutor.
Project Elective
Trainees may obtain practical experience in the process of drug discovery, pharmacokinetics, drug toxicity, study design, study monitoring, and regulatory issues either at Pfizer, Merck or at the Food and Drug Administration.
