| T
H E N I H C A T A L Y
S T |
M
A R C H – A P R
I L 2004 |
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CLINICAL
RESEARCH TRAINING AT NIH: THE LONG
(DISTANCE) AND SHORT
OF IT
|
by
Cherry Graziosi,
program assistant,
and Frederick
Ognibene, director,
Office of Clinical Research Training
and Medical Education, CC
|
Long-distance
learning for medical professionals has been made a lot easier, thanks to the
NIH Clinical Center (CC) Office of Clinical Research Training and Medical Education.
Established in May 2003, the office currently directs five distance-learning
courses. Here’s the line-up:
| CLINICAL
RESEARCH CURRICULUM CERTIFICATE |
|
The Office of Clinical Research Training
and Medical Education also administers the Clinical
Research Curriculum Certificate program.
Fellows and other allied health-care professionals
who successfully complete the mandatory portion of the program receive
a certificate.
An additional commendation is awarded with
the completion of at least one of four supplemental or elective components.
The mandatory components
of this certificate program are:
Enrollment in Introduction
to the Principles and Practice of Clinical Research, including
a final examination.
Successful participation in the course on Ethical
and Regulatory Aspects of Human Subjects Research (videocast
access).
Successful completion of on-line Clinical Research
Training for all principal investigators; registration information
can be found here; content
information can be found
here.
Successful completion of computer-based training course
for NIH IRB members and either
1) IRB protocol approval as a principal investigator, or 2) a three-month
"term" or attendance at at least four IRB meetings as an ad
hoc member with responsibility for a protocol’s review, or 3) if
one cannot be a principal investigator on a protocol (IC variable), then
serving as either a "protocol chairperson" (NCI model, for example)
or "providing significant contribution to the writing of a protocol."
The supplemental
or elective components are:
Successful completion of Principles
of Clinical Pharmacology, based on 75 percent attendance requirement
Successful completion of an FAES course
in statistics or epidemiology
Completion of approved IC-based programs in clinical research
FDA experience (with, for instance, INDs, data monitoring, audits) through
the annual Reviewer Training: Introduction to
the Regulatory Process course offered by FDA/CBER.
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Introduction
to the Principles and Practice of Clinical Research. Begun in
1995 with 25 students, the course attracted more than 650 health-care professionals
in the 2003–2004 academic year, including students participating from as
far away as Lima, Peru. To date, 3,417 health professionals have availed themselves
of this program, which teaches medical researchers how to design and conduct
a successful clinical trial.
In addition to the U.S.
Naval Medical Research Center Detachment in Lima, other off-site locations this
year include Meharry Medical College in Nashville; Morehouse School of Medicine
in Atlanta; Children’s National Medical Center, George Washington University
Medical Center, and Georgetown University Medical Center in Washington, D.C.;
the State University of New York Medical University in Syracuse; the University
of Texas Southwestern Medical Center in Dallas; and the University of Puerto
Rico in San Juan.
Clinical Research
Training. All clinical principal investigators with a protocol approved
through the CC are required to take the course and successfully complete a final
examination.
Principles
of Clinical Pharmacology. Established in 1998, this course provides
an introductory review of pharmacokinetics, drug metabolism and transport, assessment
of drug effects, drug therapy in special populations, and contemporary drug
development. In addition to the NIH location in Bethesda, Md., five off-site
locations participated in the 2003–2004 course: Georgetown University School
of Medicine, Washington, D.C.; Indiana University School of Medicine, Indianapolis;
NIA, Baltimore; Northwestern University Medical School, Chicago; and the David
Geffen School of Medicine of the University of California, Los Angeles. The
program has enrolled 1,574 students since its inception and runs from September
through April, one day a week, at the CC.
NIH-Duke Training Program in Clinical Research.
Designed primarily for clinical fellows and other health professionals who are
training for careers in clinical research, this course teaches research design,
statistical analysis, research ethics, and research management. It’s taught
at the CC via videoconference from Duke and also by adjunct faculty on campus.
Thus far, 31 students have received a Master of Health Sciences in Clinical
Research from Duke University.
The University of Pittsburgh’s
Training in Clinical Research Program. Like the NIH-Duke program, this
program offers advanced training in clinical research through ideoconferenced
courses at the CC. The University of Pittsburgh confers either a Master of Science
Degree upon completion of core curriculum courses plus 15 credits of elective
courses. The university also offers a certificate to those who do not take the
full course but complete an extensive summer program and seminars.
CC Director John
Gallin observes that improving clinical research training is a major initiative
of the NIH Roadmap, introduced by NIH
Director Elias Zerhouni
last November.
"In the past,"
Gallin says, "researchers relied on mentors to teach them how to conduct
clinical trials. We have established a formalized training program to fill this
critical gap, and we’re extending it worldwide."
For more information on
any courses or programs offered by the Office of Clinical Research Training
and Medical Education, call 301-496-9425.
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