World-class cyclist and cancer survivor Lance Armstrong credits his life and his five Tour de France victories to the doctors, researchers and clinical trial participants who made the treatment for his own testicular cancer possible. Displaying his will to win Armstrong and two team members from the Tour of Hope, a week-long bicycle relay across the United States to raise awareness about cancer research and the importance of clinical trials, took a break from the trek and visited the NIH Clinical Center in October 2003.
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 2003, all 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 2,000 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 online at http://www.cc.nih.gov/researchers/training/crt.shtml.
Introduction to the Principles and Practice of Clinical Research
This educational course, introduced in 1995, teaches clinical researchers how to design clinical trials and implement clinical protocols. More than 3,400 individuals have enrolled since its inception. Students participate on the NIH main campus in Bethesda, Maryland as well as at remote sites via teleconference. In 2003, this course was transmitted to nine different geographical sites and 379 students.
Master’s Degree in Clinical Research
Two different collaborative programs lead to graduate degrees in clinical research. A Master of Health Sciences degree in Clinical Research is awarded to individuals who successfully complete a distance-learning partnership program between the Clinical Center and Duke University and a Master’s degree in Clinical Research is available to those successfully fulfilling the requirements in a Clinical Center-University of Pittsburgh School of Medicine program.
Principles of Clinical Pharmacology
The NIH Clinical Pharmacology PRAT (Pharmacology Research Associate) post-doctoral training program (nicknamed ClinPRAT) is designed to create a cadre of physician-scientists with competency in the clinical development, evaluation and therapeutic use of small molecule- and biotechnology-based pharmacotherapy. A Principles of Clinical Pharmacology evening course is part of the ClinPRAT program and consists of a series of lectures that cover what researchers must know about the principles of drug development and clinical use.
Ethical and Regulatory Aspects of Human Subjects Research
This annual course, sponsored by the Department of Clinical Bioethics, offers education and training in research ethics for intramural scientists and research staff. 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.
Clinical Research Curriculum Certificate Program
This elective program is for physicians, graduate medical education trainees, clinical fellows, staff clinicians, investigators, dentists, and allied healthcare professionals who are fully engaged in, or intend to become engaged in, clinical or translational research. The Clinical Center will issue a formal certificate to those successfully completing the clinical research curriculum (Introduction to the Principles and Practice of Clinical Research, the Ethical and Regulatory Aspects of Human Subjects Research and the Clinical Research Training Course).
Great Teachers Series
A monthly feature of the Clinical Center’s Grand Rounds, the Contemporary Clinical Medicine-Great Teachers Program, is defined by important topics in clinical medicine and great teachers. The series attempts to expand medicine in the broadest sense and to recruit speakers of all genders, races and places, if they are the “best teachers.” Recommendations for topics and potential teachers are welcome. Drs. John Hurley and Paul Plotz co-chair the series.
The Astute Clinician Lecture Series
The sixth annual Astute Clinician speaker, Dr. Richard T. Myamoto, Arilla Spence DeVault Professor and Chairman of the Department of Otolaryngology-Head and Neck Surgery at the Indiana University School of Medicine, addressed the past, present and future of cochlear implants. The Astute Clinical Lecture honors an American scientist who has observed an unusual clinical occurrence, and by investigating it, has opened an important avenue of scientific research.
Clinical Research Training and Medical Education
Future waves of clinical investigator trainees will benefit from the Clinical Center’s new Office of Clinical Research Training and Medical Education. Rapid growth in the need to expand clinical research training opportunities at the Clinical Center, and for NIH intramural scientific research in general, spurred establishment of the new office in 2003. This office centralizes many of the existing research training and medical education functions and emphasizes the organization’s commitment to developing a cadre of well-trained and highly-skilled physician-scientists.
(left) Dr. Frederick P. Ognibene leads the new Office of Clinical Research Training and Medical Education.