AAMC Reporter, November 2000: Despite Growth in Ranks, Minority Faculty Promotions Lag

VOLUME 109, NUMBER 2

JORDAN J. COHEN, M.D., PRESIDENT

NOVEMBER 2000

Strength in Numbers: Medical Centers Partner to Improve Clinical Trials

By Barbara Gabriel

Academic medical centers are teaming up to reclaim turf lost to commercially sponsored research organizations. Designed to better meet the needs of industry sponsors, new alliances offer multiple trial locations and cut through the red tape often associated with academic clinical trials.

"First and foremost, industry sponsors want multisite trials," says Roger Meyer, M.D., senior consultant for clinical research in the AAMC's Division of Biomedical and Health Sciences Research. "Alliances make academic medical centers more appealing to the commercial sector, which previously had to approach one institution at a time."

The broadest of these new alliances is the Multicenter Academic Clinical Research Organization (MACRO), a research partnership among five major academic medical centers: Washington University School of Medicine, the University of Pennsylvania School of Medicine, Vanderbilt University, Baylor College of Medicine, and the Harvard Clinical Research Institute.

MACRO was organized by Daniel P. Schuster, M.D., Washington University School of Medicine's associate dean for clinical research, and Greg Koski, M.D., Ph.D., formerly with Partners HealthCare System and now director of the Office for Human Research Protections.

MACRO aims to streamline the approval process for joint research projects, while maintaining rigorous quality controls for human subjects protections, says Dr. Schuster, who also directs Washington University's Center for Clinical Studies. "Industry has identified the institutional review board approval process as one of the greatest impediments to using academic medical centers for clinical trials," he explains. "It is often cited as one of the reasons the share of clinical trials AMCs participate in has fallen from about 90 percent a decade ago to about 40 percent today."

Dr. Schuster explains that MACRO's arrangement, approved by NIH, expedites the research review process for multicenter projects. Under its guidelines, one of the five MACRO institutions will be designated as the lead review group for any given proposal. The IRB at each participating center will receive comprehensive review documents, but only the lead group's IRB will perform a full review.

The other participants will complete abbreviated administrative reviews. Each institution will then be provided with all comments and minutes from the full review so it may voice any concerns.

Dr. Schuster adds that the MACRO alliance will allow the affiliated partners to identify best practices among themselves. "Those practices will eventually become part of the standard operating procedures within the five institutions, and as a result, we will strengthen the overall protection of human subjects."

Dr. Koski also stresses the importance of promoting "good clinical practices" among investigators. He notes that any delegation of responsibility for research oversight does not diminish the institutions' accountability, and that the primary motivation of academic institutions involved in clinical trials should be the conduct of science for the improvement of health.

Drs. Koski and Schuster spoke at a recent AAMC- and industry-sponsored workshop on innovative clinical trials approaches that included representatives from leading pharmaceutical companies and academic medical centers. The conference also showcased a number of academic clinical trials offices, which oversee a network of research sites but, unlike MACRO, do not require coordination of IRBs to review research.

Michael I. Leahey, director of clinical trials at Columbia Presbyterian Medical Center, presented the perspective of one of academia's most successfully established and comprehensive clinical trials offices. Columbia's office, which reported contracts totaling $34 million in its most recent fiscal year, has set up a new partnership with Cornell University and New York-Presbyterian Hospital. The resulting Clinical Trials Network is currently conducting trials in 47 sites with 400 enrolled patients.

Also at the conference, Rowena Dolor, M.D., discussed Duke University's Clinical Research Institute, a prominent leader in clinical trials that has been identified by many as the nation's only model of an academic contract research organization.

Another example of a streamlined clinical trials office managing a network was offered by W. David Watkins, M.D., Ph.D., professor at the University of Pittsburgh and, with Leahey, a member of the conference's steering committee. The Pittsburgh Clinical Research Network (PCRN), of which Dr. Watkins serves as medical director, is a subsidiary owned by the University of Pittsburgh Medical Center Health System and began operating in 1998 to serve industry-sponsored clinical research trials.

PCRN enables industry sponsors to navigate more easily 17 regional hospitals and 14 affiliated hospitals. "It's important that we come up with a more consistent approach to how we conduct clinical research in general," Dr. Watkins says. "Once common practices are better defined and accepted, it will be easier for different institutions to work together, because they'll all be talking a common language."

Above all, the conference provided evidence that academic alliances and networks will continue to form and evolve. James Breitmeyer, M.D., Ph.D., CEO of the recently formed Harvard Clinical Research Institute (HCRI), composed of Harvard Medical School, Partners HealthCare, and CareGroup, discussed HCRI's endeavor to coordinate and expand clinical trials services, including study design, patient accrual, and data analysis across the Harvard system.

"Industry had indicated that they were not interested in working with inefficient clinical sites as they were being managed in many AMCs," explains PCRN's Dr. Watkins. "Our network is our response to that."

A summary of the conference "Getting It Right: Clinical Trials for the Next Decade" is available from the AAMC's Division for Biomedical and Health Sciences Research.

For more information, contact Steve Heinig, (202) 828-0488