November 18, 2001
Every new drug that’s approved by the FDA has years of clinical research behind it. The same is true of all new medical techniques and methods. But for years there has been a shortage of people choosing careers as clinical investigators.
“Unlike basic research, where people are given laboratories and protected time for their work, people doing clinical research have been overwhelmed by other clinical responsibilities,” said Mitchell Friedman, Edward G. Schleider Education Professor of Pulmonary Diseases and chief of the section of pulmonary diseases, critical care and environmental medicine. “Also, the National Institutes for Health and other organizations haven’t funded clinical research to the same degree that they do other programs.”
Adding to the problem has been a lack of training in clinical research. The scope of training required to pursue a career in clinical research is complex, long and time-consuming. Most people who do it have to figure it out on their own, on the job. But that’s starting to change.
The NIH has instituted a series of new awards for clinical research (K23 and K24 awards) that are designed to encourage clinical researchers to compete for peer-reviewed funding. Because of the recognition by the NIH and the scientific community of the length of training required to prepare for a career in clinical research, a new and promising NIH award program also was developed, the K30 Clinical Research Curriculum Award program. When Friedman heard about the NIH’s clinical research curriculum award, he thought the proposal was interesting and that Tulane would be competitive for the award.
“We have a lot of strengths here at Tulane,” he said. “We have major schools both in medicine and in public health, we have a strong past history of doing important clinical research, and we have an NIH-sponsored general clinical research center that we share with LSU [Louisiana State University].”
Fifty-five academic health centers have received K30 awards. Tulane was the only school in the area to receive the NIH’s K-30 Clinical Research Curriculum Award. The grant to Tulane was used to establish an MPH program in clinical research, which is a joint program of the medical school and the School of Public Health and Tropical Medicine. Friedman is the program director.
It’s built on the same core courses that are required for all MPH students, and is targeted towards Tulane fellows, residents and junior faculty, medical school and bioengineering students, and students and faculty from Xavier University’s pharmacy school. Although 55 institutions received the award, not all established formal degree programs.
Tulane’s program, which enrolled its first students this fall, is intended to help clinicians become more successful in competing for funding.
“We’ve already received a lot of positive feedback about the program. This will be a big bonus in recruiting fellows and residents,” said Stephanie Colbert, who coordinates the program. Now she’s working on the details of a new executive MPH program based on the same curriculum.
The executive program will use an online distance-learning format and also will include 12 weekend visits to campus during the course of the 18-month program. Lectures will be recorded and will be available to students at any time, but there also will be interactive, real-time office hours for each course.
Many professors who teach the core courses are already experienced in conducting classes online, thanks to the distance-learning program in occupational health and safety management, which began in 1998. However, the clinical research program will use different software and will be asynchronous to better accommodate students’ schedules. The executive program is targeted toward people working in the field, particularly in the pharmaceutical industry.
“Most of the clinical research done in the country is done by pharmaceutical companies,” Friedman said. “Nobody receives formal training in regulatory issues, design issues or statistics.”
There are currently no programs offering an executive MPH in clinical research in the United States. Tulane’s program may be the first, according to Colbert. The program will be unusual and is attracting nationwide interest.
“This will be something that will help people throughout the research community also get to know Tulane,” Colbert said. “It will develop that relationship."
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