Second Opinion

In 1994 the Institute of Medicine highlighted a decline in the number of physicians applying to the National Institutes of Health for funds to conduct clinical research. A year later the director of the NIH appointed a committee to review the status of clinical research in the United States.

The committee recommended that the NIH make grant awards to academic health centers to develop courses and instruction in the fundamentals of clinical research. In response, NIH initiated the Clinical Research Curriculum Award, or K30, funding mechanism.

To take advantage of this development, I organized a group of faculty that included Stephen Looney and L. Jane Goldsmith from family and community medicine; W. Paul McKinney, Christine Ritchie and Martin Weinrich from the Department of Medicine; and Stephen Myers from pharmacology to develop courses in epidemiology and biostatistical methods for our young researchers.

Others from the Belknap Campus, including Osborne Wiggins from philosophy, Stephan Gohmann from economics, and Susan Kelly and Alan Furr from sociology developed courses in the ethical conduct of clinical research, social and behavioral science, and health economics.

These became the core courses for the Clinical Research, Epidemiology and Statistics Training Program and the basis for our application to NIH for a K30 award.

We designed CREST to provide junior faculty and house staff (fellows and residents) with three levels of training: a graduate certificate in clinical investigation science, a master's of science in public health and a Ph.D. in epidemiology-clinical investigation science. Medical students can earn a joint M.D.-M.S.P.H. degree in five years.

We received a $1 million K30 Award in August 2000.

Of the 15 benchmark universities for UofL, only two others -- the University of Alabama at Birmingham and Indiana University -- have K30 awards. This shows that UofL is gaining recognition as a major research center.

CREST courses are offered from 4 to 5:30 p.m. to accommodate the schedules of busy clinicians. Trainees work with established clinical researchers who mentor them through the program and the writing of a research paper or grant proposal.

We have been able to expand the CREST program with new faculty, new courses and new facilities in Louisville's MedCenter One, where Tammi Thomas joined us recently as program coordinator. The planned opening of the General Clinical Research Center under the direction of Craig McClain will be a valuable resource and training site.

This summer we are excited about a new course titled "From Bench to Bedside: An Introduction to Clinical Research." In the fall, we will add a course on new drug and device development that will be taught by Cathy Whelan from University Hospital and Susan Muldoon from the Institute for Public Health Research.

Both courses will focus on the challenges and rewards of clinical research and the process of moving new pharmaceuticals and biomedical devices from the laboratory to clinical practice.

The impact of the CREST program on the growth of research at UofL is already evident: More than 60 percent of the initial cohort of M.S.P.H. graduates has received NIH funding. Several fellowship and residency programs now require the CREST program as part of their training, and the number of junior faculty from the School of Medicine and the School of Dentistry enrolling in the program is increasing.

Currently, 24 trainees are enrolled in the masters program and 10 more are working toward their Ph.D.s. A new class will enter the program this summer, including the first medical students seeking the M.D.-M.S.P.H. degree.

The administration has been very supportive. Joel Kaplan, dean of the School of Medicine, and John Williams, dean of the School of Dentistry, provide funds for tuition that have enabled us to create 12 "Clinical Research Scholar" awards for residents and fellows. 

I'm told the CREST program and the Clinical Research Scholar awards make UofL attractive to many of the best applicants for residency and fellowship positions because CREST graduates will have an edge in competing for training and faculty positions at the most prestigious academic health centers.

In this respect, the CREST program is truly a "gateway to academic medicine."

NIH hopes that the K30 awards will increase the number of physicians entering clinical research and academic medicine. At UofL, we are committed to the CREST program and to becoming a national leader in educating the next generation of clinical research scientists.

Carlton A. Hornung, Ph.D., M.P.H., is a professor of medicine at UofL and director of the CREST Program. He is a member of the board of directors of the Association of Clinical Research Program Directors and an invited member of the Association of Patient Oriented Researchers. He has received a number of research grants and is currently co-principal investigator of a federally funded clinical trial of a home monitoring system for patients with heart failure.