Administrators give clinical research poor bill of health
JAMA study highlights glaring problems in system
Harvard investigators decided to take a look at the overall health of clinical research conducted in teaching hospitals and medical schools by interviewing the department chairs and the senior research administrators in U.S. medical schools. What they found was that the overall perception is that the clinical research mission currently is under greater stress and less healthy.
"I think this study for me confirmed a lot of perceptions that I have heard bandied about for a long time," says Eric G. Campbell, PhD, instructor in health policy at Harvard Medical School in Boston. About half of the 478 respondents to the survey rated the health and robustness of their clinical research enterprise either good or excellent. For nonclinical research, 63% of respondents rated the research either good or excellent.1
Medical schools and teaching hospitals have been subject to the same managed care and other market forces that have transformed much of the country’s health care system. So physicians have increased pressure to see more patients, and teaching hospitals have less money to support the kinds of clinical studies that are not funded by grants or outside sources, Campbell explains.
When asked to what extent IRBs were a factor in the problem, respondents reported that it was low on the list of challenges facing the institutions, Campbell adds. The factors contributing to a declining quality of clinical research in medical schools and teaching hospitals, according to the JAMA study, are:
- Institutions that exist in competitive managed care environments receive lower reimbursement from insurers and this leaves them with a reduced ability to cross-subsidize clinical research.
- Health plans often direct patients to lower-cost providers, and this makes patients unavailable to participate in clinical research.
- Young faculty spend more time seeing patients and have less time for research.
The problem with clinical research within academic medical center institutions has been a concern of the American Association of Medical Colleges (AAMC) for several years, says David Korn, MD, senior vice president for biomedical and health sciences research at the AAMC in Washington, DC.
Better infrastructure needed
About a year ago, the AAMC came out with a two-volume report on what medical schools can do to strengthen and improve the quality of clinical research they conduct, Korn adds. "The bottom line of all of that is that there are major needs in the community," Korn says. "And there also are needs that the National Institutes of Health (NIH) has begun to grapple with in terms of funding policies and mechanisms to build infrastructure for present-day clinical research that largely has not been well-developed for what we call basic research."
It’s sometimes difficult to evaluate the value of clinical research done at medical schools because it takes a while for new research to get out into the community and be verified and extended, Campbell notes. "Evaluating the impact of unfunded research is hard to do analytically," Campbell says. "My own belief is that investigators need time and money to begin to examine something that piques their interest, and it’s often very hard to go outside the institution and get that money."
The AAMC has a few recommendations for how the medical and research community may improve the quality of nonfunded clinical research, and one of the most important goals is to improve education of clinical investigators, Korn says. "There’s a need for more rigorous training of investigators, of young people, who wish to do quality clinical investigation," Korn says. "Traditionally over the centuries people have done research on patients, human subjects, learning it by apprenticeship and spending time with people who do this kind of research."
That tradition no longer will work because clinical research is more complex today, requiring skills in methodology, and the ethical considerations are more important than they were previously, Korn adds.
Drastic changes since WWII
One of the issues affecting medical school research is that standards have changed and ethical practices have been strengthened progressively since World War II, Korn explains. Many studies that were permitted in the first half of the 20th century would never receive federal or IRB approval today, and yet some of these studies have been beneficial to society. "I’m not in approval of people who take past behavior and apply current day standards because it’s a cheap shot," Korn says. "We’ve evolved in our expectations in how to do research with human beings, and so all of those kinds of issues need to be cultivated in men and women who wish to develop their research careers."
Given the current high ethical standards for clinical research, it’s important for IRBs to walk that fine line of balance in making their decisions, Campbell suggests. "We should do everything we can to make sure our IRBs are strong and powerful in protecting patients," Campbell says. "But at the same time, that strength and power comes with a price, and it can increase the burden and demands on researchers and administrators in terms of increased paperwork, time, reporting, and so on," Campbell adds. "So we need to balance that because clearly clinical researchers already are stressed, and they may need more administrators to help them, which will put increased financial stress on departments."
Reference
1. Campbell EG, Weissman JS, Moy E, et al. Status of clinical research in academic health centers, views from the research leadership. JAMA 2001; 286(7):800-806.
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