July 28, 2000

VUMC joins effort to ease joint clinical research projects

Featured Image

Dr. Jim Loyd (left), Kirk Lane, Ph.D. (seated), Dr. John Newman and Emily Loyd study an image of the PPH mutation. (photo by Dana Johnson)

VUMC joins effort to ease joint clinical research projects

Vanderbilt University Medical Center will participate in a new alliance between five major academic medical centers that will streamline the approval process for joint clinical research projects.

The Multicenter Academic Clinical Research Organization (MACRO) includes Vanderbilt, Washington University School of Medicine in St. Louis, the University of Pennsylvania, Baylor College of Medicine, and Partners HealthCare System, a Massachusetts-based health care delivery network that includes Harvard-affiliated Brigham and Women's and Massachusetts General hospitals.

MACRO, approved by the National Institutes of Health's Office for Protection from Research Risks, will improve efficiency and reduce redundancy of effort between academic health care centers across the United States, while preserving important protections for patients.

"Clinical trials research offers the final proof that a new therapy is effective and has the most immediate impact on patients' health," said Dr. Italo Biaggioni, associate professor of Medicine and Pharmacology and medical director of the Clinical Trials Center at Vanderbilt.

Because of the need to include a large number of patients, clinical trials are often a collaboration among many investigative sites. Over the last 10 years, trials have shifted away from academic medical centers, as pharmaceutical companies have used one commercial institutional review board (IRB) to approve multiple nonacademic sites, Biaggioni said. Using academic sites requires individual approval from each institution's IRB.

MACRO will allow the associated academic institutions to use one IRB as the central IRB, expediting the research review process for multicenter projects.

For any given proposal, one of the five institutions will be designated as the lead review group.

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 four participants will complete abbreviated administrative reviews. Each participating institution will then be provided with all comments and minutes from the full review so that they may voice any new concerns.

"It is our goal that by increasing the clinical trials participation of academic institutions of the caliber of the five participating in MACRO, we will have a positive impact on the quality of clinical trials research," Biaggioni said.

MACRO will address research proposals that require only IRB approval. It will not involve itself at first in trials that require additional review procedures such as genetics, cancer, and AIDS.

"This unique research consortium is committed to upholding current regulatory guidelines while creating a more welcoming environment for government and industry-sponsored collaborative research," said Dr. Daniel Schuster, professor of Medicine and associate dean of Clinical Research at Washington University, who with Dr. Greg Koski, formerly with Partners HealthCare System, helped organize MACRO.

Koski is now director of the NIH's Office for Human Research Protection (the new name for the Office for Protection from Research Risks). Dr. James Breitmeyer, president and chief executive office or the Harvard Clinical Research Institute, replaced Koski as a project leader for MACRO.

At Vanderbilt, the Clinical Trials Center worked closely with the IRB, through Dr. Gordon R. Bernard, professor of Medicine and medical director of the IRB, and Robin Ginn, to make the agreement possible. Lynda Lane, clinical director of the Clinical Trials Center, will serve as the Vanderbilt contact for the MACRO agreement.