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It is a top Clinical Center priority to train clinical researchers in the responsibilities involved in planning and conducting clinical research and to increase the pool of clinical researchers with expertise in various specialties. By building an infrastructure for clinical research training on NIH’s main campus, the Clinical Center has helped address the nationwide shortage of training opportunities for physicians, fellows, medical and dental students, nurses, and allied health professionals interested in clinical research.

The Office of Clinical Research Training and Medical Education, established in the Clinical Center in May 2003, is responsible for developing, administering, and evaluating clinical research training and medical education initiatives that aid the professional growth and development of NIH clinician-scientists and other health care professionals. Through distance teaching classrooms, the NIH Clinical Center can now export its clinical research training programs throughout the United States and the world.

In 2004 the curriculum in clinical research was formalized and a certificate program implemented to acknowledge completion of and outstanding performance in all of the curriculum’s core components. The first certificate was conferred on Dr. Linda Griffith (photo upper right), who satisfied all of the certificate requirements with commendation. The curriculum program was described in an article about clinical research training in Clinical Trials Administrator (February 2004, Vol. 2, No. 2, pp. 21-22) and in the NIH Catalyst (March/April 2004, p. 13). An intranet site describing the target audience and the curriculum was launched in May 2004: <http://intranet.cc.nih.gov/clinicalresearchtraining/curriculumcert.shtml>. The curriculum includes the following four courses directed at improving how clinical research is conceived, monitored, and conducted. These courses may be taken as part, or independent, of the clinical research curriculum.

Introduction to the principles and practice of clinical research. This course, established in 1995, provides formal training on how to effectively design a clinical trial and implement clinical protocols. To date, 4,138 students have registered for the program, and 1,325 certificates have been awarded. The 2004-2005 course has 721 registrants (274 on NIH’s Bethesda campus and 447 participating at 14 remote sites by “live” videoconference). The archived content is provided to Seoul National University College of Medicine in North Korea, the National Cancer Center in Singapore, and the University of Bergen in Norway. A second edition of the course textbook, published by Academic Press in 2002, is being planned.

Principles of clinical pharmacology. Designed to meet the needs of researchers who have an interest in the clinical pharmacological aspects of contemporary drug development and utilization, this course is entering its seventh year. Of the 1,962 enrollees since the course began in 1998, 448 students registered for the 2004-2005 program, and 520 certificates of participation have been awarded. A second edition of a companion textbook published by Academic Press in 2001 is being developed.

Ethical and regulatory aspects of clinical research. More than 2,000 students have enrolled in this program (415 in fall 2004), which was implemented in 1999 to offer formal education and training in research ethics and to expose students to a broad range of issues important to the ethical conduct of clinical research. Individual sessions and group institutional review board (IRB) reviews are presented by leading experts in various areas of clinical research ethics. The course was broadcast by satellite and the Internet to participants at the Western IRB in Olympia, Washington.

A textbook, Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary, was published by Johns Hopkins University Press.