The Clinical Center continues to serve a central role in addressing clinical research training needs nationwide. In recognition of the fact that training opportunities for physicians, fellows and medical students in pursuit of clinical research are limited, the Center has taken a lead role at NIH’s main campus to build a strong infrastructure for clinical research training. NIH’s curriculum in clinical research includes five courses aimed at improving how clinical research is conceived, monitored and conducted.

	Videoconferencing enables clinicians and allied health professionals to participate in distance learning courses.

Clinical Research Training. A required clinical research-training course is the most recent addition to the clinical research curriculum and addresses one of the Standards for Clinical Research within the NIH Intramural Program. The course is available on the internet (http://www.cc.nih.gov/ccc/cr/index.html). Before approval of new clinical protocols, investigators must take the course and pass an exam. Course offerings became web-based in 2001. To date, 939 principal investigators have successfully completed the course—431 during live course sessions and 508 via the Internet. In addition to domestic U.S. locations, institutions worldwide have accessed this electronic resource including sites in Europe, Central America, Asia, and the Caribbean.

Introduction to the Principles and Practice of Clinical Research. In 1995, Clinical Center Director Dr. John Gallin introduced this educational course dedicated to teaching clinical researchers how to design clinical trials and implement clinical protocols. The course averages 300 registrants annually with more than 2,000 individuals enrolled since its inception. Students participate on NIH’s main campus as well as at NIH extramural sites via teleconference. Classes meet twice a week for 6 months. Subjects covered during the course are epidemiological methods, study design and development, protocol preparation, patient monitoring, quality assurance, Food and Drug Administration issues, data management, and legal-ethical topics, including the protection of human subjects. A new companion text, The Principles and Practice of Clinical Research, now serves as a comprehensive, complementary course resource for researchers on the history of clinical research and the design and implementation of clinical trials.

Master’s Degree in Clinical Research. Two different collaborative programs lead to graduate degrees in clinical research. A distance learning program between the Clinical Center and Duke University began in 1998. NIH participants complete coursework mainly through videoconferences with Duke faculty; NIH staff members teach other classes as Duke adjunct faculty. Duke University’s School of Medicine awards a Master of Health Sciences in Clinical Research to those who successfully complete the coursework. In 2001 a program leading to a Master’s in Clinical Research was initiated between the Clinical Center and the University of Pittsburgh School of Medicine. The program is available to physicians, dentists and allied health professionals.

Principles of Clinical Pharmacology. Few medical schools offer formal courses in clinical pharmacology. This post-doctoral training program, which began in 1998, is the result of a partnership between the Clinical Center and several NIH Institutes. The coursework covers what researchers must know about the clinical aspects of drug development and use. Topics include pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and contemporary drug development. A new companion text, Principles of Clinical Pharmacology, is now used with the course teachings. The book was edited by Dr. Arthur J. Atkinson, Jr. of the Clinical Center. Dr. Atkinson also oversees the entire clinical pharmacology education program.

Ethical and Regulatory Aspects of Human Subjects Research. This course, held annually in the fall by the Clinical Center’s Department of Clinical Bioethics offers education and training in research ethics for intramural scientists and research staff. National experts in the field of bioethics conduct the classes. The history of human subjects research, research principles and guidelines, the ethics of clinical trial design, patient recruitment, and informed consent are examined during seven weekly 3-hour sessions. The course has steadily gained in popularity. The first course offering in 1999 had 100 registrants. This past year more than 400 individuals signed up. NIH mandates that all extramural researchers participate in training in the responsible conduct of research.

Contents

Introduction

Message from the Director

Historical Highlights

Clinical Center Governance and Accreditation

Major Programs

The Mark O. Hatfield Clinical Research Center

The Edmond J. Safra Family Lodge

Clinical Research Initiatives

Clinician Highlight

Clinical Research Training Programs

Organizational Effectiveness and Efficiency Initiatives

Public Outreach