Contact:
Colleen Henrichsen, Warren Grant Magnuson Clinical Center Communications Office, (301) 496-2563
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Contact: Colleen Henrichsen, Warren Grant Magnuson Clinical Center Communications Office, (301) 496-2563 |
(Bethesda, Md.) Clinical research--evaluating new and promising treatments in people--provides a blueprint for better health care. To help refine and focus those blueprints, researchers at the Warren Grant Magnuson Clinical Center at the National Institutes of Health (NIH) have developed a series of programs aimed at improving how clinical research is conceived, monitored and carried out.
"This is an extraordinary era of innovation and progress for medicine and science," notes Dr. John I. Gallin, director of the NIH Clinical Center (CC) and associate NIH director for clinical research. "Clinical research can be beneficial and successful only when physician-researchers have the necessary training and expertise to conduct it. Historically, medical students depended on willing and able mentors to teach the intricacies of clinical research. That approach simply doesn't work today."
The nation's clinical research hospital, the NIH Clinical Center offers an excellent environment for exploring new approaches to identifying and providing the tools that researchers need. "Effective clinical research is both an art and a science," Dr. Gallin adds, "and training in clinical research depends on a thorough grounding in the basic techniques, rich opportunities for practical application, and the flexibility to meet the changing needs of medical science and health-care consumers."
How do
clinical researchers learn? Bridging the gap.
Cornerstone for Clinical Center training efforts is the course,
"Introduction
to the Principles and Practice of Clinical Research,"
established in 1995. "The program teaches researchers how
to design a good clinical trial," Dr. Gallin, who serves
as course director, points out. 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 September-February.
Twenty-five students participated in the course's first offering as a pilot. This year, 324 researchers, mostly physicians, have registered, including 79 who attend via teleconference site in Baltimore, Georgetown University and the University of Puerto Rico. The course also has been video-conferenced to National Institute of Environmental Health Sciences (NIEHS) in North Carolina, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) components in Arizona, and to the Rocky Mountain Labs in Montana, which are part of the National Institute of Allergy and Infectious Diseases (NIAID).
To date, 1,486 students have registered for the course, which leads to a certificate for successful completion. Dr. Gallin currently is editing a textbook to accompany the coursework.
Another distance-learning program designed to strengthen training opportunities in clinical research is collaboration between the NIH Clinical Center and Duke University that began in 1998. It's designed primarily for clinical fellows and other health professionals training for careers in clinical research. "It meets an existing need at NIH for formalized academic training in the quantitative and methodological principles for clinical research," Dr. Gallin says.
Offered are courses in research design, statistical analysis, health economics, research ethics, and research management. 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 collaboration began with 14 students enrolled from NIH. The 1999 class includes 17 students. The program can be completed in two 16-week semesters; participants typically spread course work over two years. There's also a non-degree option for qualified individuals who want to acquire specific skills in this discipline.
Clinical
pharmacology: a critical link
Another NIH Clinical Center-based training opportunity is the
course, "Principles
of Clinical Pharmacology," initiated in 1998 by Dr. Art
Atkinson. "Many medical schools don't offer formal courses
in clinical pharmacology," Dr. Gallin says. "This program
covers what researchers need to know concerning the clinical pharmacologic
aspects of drug development and use."
The course, which complements the Introduction to the Principles and Practice of Clinical Research, includes a review of pharmacokinetics, drug metabolism and transport, assessment of drug effects, drug therapy in special populations, and contemporary drug development. Offered annually, the course is also designed to assist individuals preparing to take the certification exams of the American Board of Clinical Pharmacology.
"A great deal of the clinical research done here at the Clinical Center involves clinical trials of new drugs," explained course director Dr. Arthur Atkinson. "Clinical pharmacology is an obviously important component of the design, conduct and interpretation of these trials and it appears that our course fills an unmet need in this regard". Last year, the course drew 180 students. This year, 294 are enrolled. A companion textbook is in development.
Examining
ethical issues in clinical research
"Medicine and science can't advance unless society trusts
that progress never compromises the health and well-being of those
who participate in clinical research," explains Dr. Gallin.
"Thoughtful and continuing assessments ethical issues are
critical skills that clinical researchers need." To help
meet that need, the Clinical Center's Department of Clinical Bioethics
has put together a seven-session overview of ethical and regulatory
issues in clinical research for NIH intramural scientists and
research staff.
"The goal of the course is to provide clinical investigators and institutional review board members skills with which they can analyze the ethical issues they confront in clinical research," said Dr. Ezekiel J. Emanuel, course director and chief of the CC Department of Clinical Bioethics. "We want to train researchers so they can design their protocols to conform to prevailing ethical standards on ethical research."
The program, which began with 130 enrollees in 1998, includes sessions on the history of human-subjects research; research principles and guidelines; the ethics of clinical trial design, patient recruitment; and informed consent. A mock IRB (institutional review board) is incorporated, along with extensive panel discussions, including presentations from research patients on their experiences.
Outreach
to the nation's medical communities
The Clinical Center
RoundTable, which premiered in January 1999, features an hour-long live
broadcast to hospitals and academic health-care centers nationwide. "This
program highlights current NIH research and provides clinically relevant information
for hospital-based viewers," explained Dr. Gallin. "Our goal for this
program is to reach out to the medical public that may not be familiar with
what we do here and how it affects their practice."
The program is a collaboration among the NIH Clinical Center, Healthcare Management Television's CenterNet, and the Association of Academic Health Centers. It's also carried by TiP-TV, a training and education satellite-delivered health-care network provided by GE Medicine Systems and the Veterans Health Administration satellite television network.
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 internationally.
"The
University of Buenos Aires Medical School is exploring the possibility
of joining our teleconferencing of the Introduction to the Principles
and Practice of Clinical Research," Dr. Gallin notes. "The
University of Pittsburgh is interested in collaborating on a masters
degree program in clinical research that would include students
in disciplines other than medicine. Finding new and better treatments
and therapies depends on clinical research. Our goal at the Clinical
Center is to work with all of NIH in exploring how to improve
the conduct of that research."
The
Warren Grant Magnuson Clinical Center is a component of the National
Institutes of Health (NIH).The Clinical Center is the clinical
research hospital for NIH. Through clinical research, physicians
and scientists translate laboratory discoveries into better treatments,
therapies and interventions to improve the nation's health. NIH
is an agency of the U.S. Department of Health and Human Services.
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Questions about the Clinical Center or information
on this site? National Institutes
of Health, Warren Grant Magnuson Clinical Center, Bethesda, Maryland
20892. Last Modified 2/2000 |
