Dr. Jean D. Wilson, professor of endocrinology at UT Southwestern Medical Center at Dallas and co-author of "Clinical Research and the NIH - A Report Card," said, "There's still a great deal that needs to be done, but this points to several things to build on."
Dr. David G. Nathan of the Dana-Farber Cancer Institute in Boston co-wrote the report with Dr. Wilson.
At the time of the 1997 review, the NIH's clinical research initiative was believed to be in jeopardy. In particular, the committee found that the financial burden shouldered by many young physicians fresh out of medical school often prevents them from spending adequate time as research trainees under the guidance of a seasoned mentor.
"The large amount of debt incurred during the training of young physicians makes it very hard to launch an academic career," said Dr. Wilson. "If they could spend more time training it would greatly benefit the research enterprise in the long run."
In response to the problem, Congress passed a competitive loan-relief program for clinical research physicians, called the Public Health Improvement Act of 2000.
In 2002, $30 million was committed to the NIH's educational-loan-relief program. Of the 766 applicants, 55 percent of minority applicants were approved along with 80 percent of all other applications. The number of applications actually was low, Drs. Wilson and Nathan write, most likely because eligibility requirements were stringent. To help remedy the problem, eligibility requirements this year were relaxed for some applicants.
To help young scientists develop clinical research, a number of different programs have been instituted nationally and at UT Southwestern. The Training Curriculum in Patient-Oriented Research (TCPOR), an NIH-funded program that provides in-depth training and practical experience in clinical research, is offered at UT Southwestern and 58 other institutions around the country. The program, which includes a mentored research project, is open to M.D.s, Ph.D.s and Doris Duke Fellows. UT Southwestern is one of only 10 institutions nationally with a Doris Duke Fellowship program. The privately funded program, one touted by Drs. Wilson and Nathan as a key to bolstering clinical research, funds medical students who want to take a year off for research training.
The report also says that NIH-funded General Clinical Research Centers, located at 70 different academic health centers, including UT Southwestern, should consider increasing the number of support personnel to avoid accidents and improve the quality of research.
The original panel found that translational research - which includes the study of disease directly in patients and evaluation of therapeutic interventions (clinical application) - was sorely under-funded. So the panel recommended the establishment of NIH grant programs for young clinical investigators, called K23 grants, and their mentors, called K24 grants.
"The dollars committed to the K23, K24 and K30 (postgraduate training) programs were a small fraction of the total extramural NIH budget, but they have had a large effect on clinical research," Drs. Wilson and Nathan write. "The NIH's commitment through 2003 - a nontrivial $460 million - has provided support and improved morale in this field."
The New England Journal of Medicine review also points to the increased role private foundations and companies have played in providing grant support for young clinical researchers and their mentors. From 1997 to 2001, private-sector funding of clinical research exceeded $200 million.
"These developments reflect an increased awareness in the private and public sectors of the need to support clinical research," the report concluded.
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