NIH Clinical Center

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Clinical Research Training Programs: Clinical Center Profile 2000-2001

Recognizing that training opportunities for physicians, fellows, and medical students interested in pursuing clinical research are extremely limited, the Clinical Center has taken a leadership position to foster the development of a strong infrastructure for clinical research training. A curriculum of five courses has been developed aimed at improving how clinical research is conceived, monitored, and conducted.

Clinical Research Training. Launched in 2000, this course has been designed to address an essential standard in the guideline “Standards for Clinical Research.” It is now required for all NIH clinical researchers. The half-day course was offered twice in 2000, and is now web-based. More than 400 principal investigators have passed the course. It is taught by staff from the Clinical Center, the NIH Institutes, the NIH Office of Human Subjects Research, and FDA.

Introduction to the Principles and Practice of Clinical Research. Established in 1995, this course teaches researchers how to design a good clinical trial. It covers epidemiological methods and focuses on study design and development, protocol preparation, patient monitoring, quality assurance, and FDA issues. It also includes data management and legal and ethical issues, including protection of human subjects. The course is offered annually. Classes meet twice a week for 6 months. In 2000, 324 researchers, mostly physicians, participated, including 79 who attended via teleconference sites at Baltimore, Georgetown University, and the University of Puerto Rico. The course also has been videoconferenced to the National Institute of Environmental Health Sciences in North Carolina, the National Institute of Diabetes and Digestive and Kidney Diseases components in Arizona, and to the Rocky Mountain Labs in Montana, which are part of the National Institute of Allergy and Infectious Diseases. More than 1400 students have taken the course, which leads to a certificate for successful completion. Dr. Gallin currently is editing a textbook to accompany the coursework.

Master’s Degree in Clinical Research. Another distance-learning program designed to strengthen training opportunities in clinical research is a collaboration between the NIH Clinical Center and Duke University that began in 1998. NIH participants complete coursework primarily through videoconferences with faculty at Duke. NIH staff teach other courses as Duke adjunct faculty. The Duke University School of Medicine, which established its program in 1986, awards a Master of Health Sciences in Clinical Research for successful completion. The program can be completed in two 16-week semesters; participants typically spread course work over 2 years. To date, eight participants have received master’s degrees. Seventeen students enrolled in the 1999/2000 academic year, and 20 students enrolled for 2000/2001.

Ethical and Regulatory Aspects of Human Subjects Research. The Clinical Center’s Department of Clinical Bioethics conducts a seven-session overview of issues important to the ethical conduct of clinical research. The program, which began in 1999, is presented in the spring and fall. Sessions examine the history of human-subjects research, research principles and guidelines, the ethics of clinical trial design, patient recruitment, and informed consent. One hundred sixty students participated in the spring sessions, and 150 participated in the fall 2000 offering. NIH mandates that all extramural researchers participate in training in the responsible conduct of research, and several other institutions are using the curriculum from this course.

Principles of Clinical Pharmacology. Another NIH Clinical Center-based training opportunity, this course was also initiated in 1998. Few medical schools offer formal courses in clinical pharmacology. This program covers what researchers need to know concerning the clinical aspects of drug development and use. It includes a review of pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and contemporary drug development. It’s offered annually, running once a week September through April. In 2000, 90 students completed the course. A textbook edited by the Clinical Center’s Dr. Arthur J. Atkinson will be published in the near future.

The Future. These NIH Clinical Center-based programs to support the clinical researcher are part of an overall NIH commitment to expanding those educational opportunities nationally.

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