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Training the next generation
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:
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.