The Harvard-MIT Division of Health Sciences and Technology (HST) and Beth Israel Hospital have announced the establishment of a joint fellowship program in clinical investigation.
The multidisciplinary program, supported by Pfizer Inc., has been established to train physicians in the design and performance of clinical studies that advance the understanding and management of human disease. The program's co-directors are Robert H. Rubin, MD, of HST and Alan C. Moses, MD, of Beth Israel.
The Clinical Investigator Training Program will provide two years of training to physician-scientists who are committed to careers devoted to the transfer of advances in basic science to the study and care of human diseases.
Ten advanced level physicians per year-five from HST and five from Beth Israel-will be selected for the program, which will have two components: a didactic program devoted to a core curriculum essential for the performance of "leading edge" clinical research; and the actual performance of such research. The didactic program will be taught in concert by the institutions involved, with the Fellows from HST and Beth Israel coming together once a week for these educational sessions.
In contrast, the clinical research will be performed separately.
The disciplines represented and the research approaches taken will reflect the particular interests of HST and Beth Israel. Topics to be covered in the didactic program include biomedical ethics, biostatistics and principles of study design, clinical pharmacology, pharmaco-economics, principles of drug development, modern methods of quantitative measurement, and outcomes assessment.
Dr. Rubin is the director of the HST Center for Experimental Pharmacology and Therapeutics and is a visiting scientist at MIT's Clinical Research Center, where the HST portion of the program will be based. He is also an associate professor of medicine at Harvard Medical School and chief of transplantation infectious disease at Massachusetts General Hospital.
Dr. Moses directs Beth Israel's Clinical Research Center, and he is also associate chief of endocrinology at Beth Israel and associate professor of medicine at Harvard Medical School. Pfizer's sponsorship represents a unique form of academic-industrial collaboration-not only is the company providing financial support for the program, but Pfizer scientists and physicians will contribute to the educational aspects of the program, Dr. Rubin said.
Coordinating Pfizer's efforts will be Dr. Pierre Etienne, who is group director of clinical research and development at Pfizer's Central Research Laboratories.
"Pfizer is a research-driven company with a a half-century tradition of collaborating with medical schools and hospitals in clinical trials of drug therapies," Dr. Etienne said. "This new program is a true alliance: it allows our latest insights in clinical trial design to be shared with the brightest new medical scientists, and helps them shape the clinical practice of the future."
As emphasized by both Dr. Rubin and Dr. Moses, Pfizer receives no direct benefits for participating in this program. Pfizer is a worldwide diversified, research-based health care company headquartered in New York which employs more than 4,000 scientists and support personnel in chemical, biological and biomedical specializations.
A unique program of co-mentorship is planned for the HST Fellows research experience. Each Fellow will have two supervisors: a senior faculty member who is an expert in the basic science areas that are relevant to a particular clinical research project, and an experienced clinical investigator expert in the particular aspect of human disease and therapy being studied. Reflecting the technological and quantitative science orientation that HST brings to clinical research, the HST Fellows will be expected to apply quantitative techniques to the study of human disease. Such techniques as positron emission tomography, magnetic resonance imaging and spectroscopy, and conventional nuclear medicine techniques will be strongly emphasized in this program.
Clinical research links experimental laboratory sciences such as chemistry, biology, molecular genetics and engineering with physician-based patient care. Working with human volunteers, clinical investigators explore the underlying mechanisms of disease and identify targets in the disease process which may respond to treatment. Typically, investigators also participate as a team with other laboratory scientists to develop the interventions or treatments themselves. In addition, they develop or evaluate new methods to measure the effects of these disease interventions.
"Despite the rapid pace of discovery of the mechanisms underlying disease and the development of new forms of therapy, relatively little effort has been directed toward training physicians in clinical research," Dr. Moses said. "This program helps redress that deficiency, and will eventually bring the full power of the newest discoveries in basic laboratory sciences to the patient's bedside."
"We are selecting proven and promising physicians for this fellowship, based on both their medical training and the insights that they have brought to their laboratory study of disease processes," Dr. Rubin said.
"The experience of both the multidisciplinary classroom work and in-depth research guided by first-class mentors, will move us toward a new class of clinical scientist skilled in quantitative analysis as well as study design. In addition, it is my belief that this fellowship, together with the Center for Experimental Pharmacology and Therapeutics and the Clinical Research Center, will play an important role in promoting a unique form of clinical research at MIT, one in which the quantitative sciences, molecular biology, new technology and clinical medicine can be combined so that discoveries at the bench can be expeditiously and effectively applied to the study and control of human disease."
A version of this article appeared in the March 30, 1994 issue of MIT Tech Talk (Volume 38, Number 27).