NIH Clinical Center

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NIH mark National Institutes of Health 2003 Clinical Center Profile

Skip left navigation list link group.Contents

Introduction

Message from the Director

Historical Highlights

Clinical Center Governance and Accreditation

Organizational Structure and Programs

The Mark O. Hatfield Clinical Research Center

Preparing for the Clinical Research Center Activation

The Edmond J. Safra Family Lodge

Clinical Research Initiatives

Clinician Highlight

Clinical Research Training Programs

Organizational Effectiveness and Efficiency Initiatives

Public Outreach

End of left navigation list link group.

Clinical Research Training Programs
Photo: Nurses at the Clinical Center were recognized during “A Celebration of Nurses” in honor of the May 2002 National Nurses Week.

Nurses at the Clinical Center were recognized during “A Celebration of Nurses” in honor of the May 2002 National Nurses Week.

Recognizing that training opportunities for physicians, fellows and medical students in pursuit of clinical research are limited, the Clinical Center leads the way in building a strong infrastructure for clinical research training at NIH’s main campus and serves a central role in addressing clinical research training needs nationwide. NIH’s curriculum in clinical research includes five courses directed towards improving how clinical research is conceived, monitored and conducted.

Clinical Research Training
As of December 2002, 99 percent of NIH intramural principal investigators have successfully completed a required clinical research-training course, which addresses one of the Standards for Clinical Research within the NIH Intramural Research Program. Investigators must take the course and pass an exam before receiving approval to conduct new clinical protocols. All clinical principal investigators with a protocol approved through the Clinical Center are required to take the course. To date, nearly 1,400 investigators have taken the course through live classroom sessions and 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. The course is available on the World Wide Web at http://www.cc.nih.gov/ccc/cr/index.html.

Book cover: Principals and Practice of Clinical ResearchIntroduction to the Principles and Practice of Clinical Research
This educational course, dedicated to teaching clinical researchers how to design clinical trials and implement clinical protocols, was introduced in 1995 by Clinical Center Director Dr. John Gallin. In 2003 the course will have a robust international reach with an academic venue in Buenos Aires, Argentina joining the University of Puerto Rico as course participants. Seoul National University College of Medicine also has plans to incorporate the course into the curriculum for their graduate students. 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 and cover 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. The course typically offers continuing medical education credit for physicians. In 2002 a companion text, Principles and Practice of Clinical Research, was published for use 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. One, a distance-learning program between the Clinical Center and Duke University began in 1998. NIH participants complete coursework mainly through video conferences 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. The other, beginning in 2001, is a program leading to a Master’s in Clinical Research between the Clinical Center and the University of Pittsburgh School of Medicine. The program is available to physicians, dentists and allied health professionals.

Book cover: Principals of Clinical PharmacologyPrinciples of Clinical Pharmacology
Few medical schools offer postdoctoral training or formal courses in clinical pharmacology. The NIH Clinical Pharmacology PRAT (Pharmacology Research Associate) postdoctoral training program nicknamed ClinPRAT, which began in 1998, is the result of a partnership between the Clinical Center and several NIH institutes. It is designed to create a cadre of scientists in the clinical development, evaluation and therapeutic use of small molecule- and biotechnology-based pharmacotherapy. The Principles of Clinical Pharmacology course is open to the NIH community and 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 companion text, Principles of Clinical Pharmacology, is now used to supplement the course lectures. Dr. Arthur J. Atkinson, Jr. of the Clinical Center was the lead editor for the book and oversees the entire clinical pharmacology education program.

Ethical and Regulatory Aspects of Human Subjects Research
The Clinical Center’s Department of Clinical Bioethics sponsors this course, which offers education and training in research ethics for intramural scientists and research staff annually in the fall. The history of human subjects research, research principles and guidelines, the ethics of clinical trial design, patient recruitment, and informed consent are examined during several weekly 3-hour sessions. National experts in the field of bioethics conduct the classes. This course addresses the NIH mandate that all extramural researchers participate in training in the responsible conduct of research.

Great Teachers Series
2002 was the second year for a monthly feature of the Clinical Center's Grand Rounds, the Contemporary Clinical Medicine-Great Teachers program. The program is defined by two features: important topics in clinical medicine and great teachers. The focus is on the quality of teaching, not fame or research. The series attempts to cover medicine in the broadest sense and to get speakers of all genders, races and places, if they are the best teachers. Topics and potential teachers are selected from among recommendations made by medical staff members, focus groups, outside experts, colleagues, and co-chairs Drs. John Hurley and Paul Plotz. Continuing medical education credits are available for program participants. The program is supported by NIH institutes and centers, the Clinical Center, the Foundation for Advanced Education in the Sciences, and the NIH Deputy Director’s Office for Intramural Research.





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