WIRB-Copernicus Group (WCG), a major provider of regulatory and ethical review services that includes three cancer-focused institutional review panels, has formed a partnership with the Prostate Cancer Clinical Trials Consortium (PCCTC), a multicenter CRO, to improve the quality and efficiency of the consortium’s research review process.
PCCTC, an independent subsidiary of the Memorial-Sloan Kettering Cancer Center, is comprised of physicians who specialize in prostate cancer research at 15 academic institutions and work with some of the 69 National Cancer Institute-designated comprehensive cancer centers. According to Memorial-Sloan Kettering, the academic medical centers’ mission is for PCCTC members to design, implement and complete hypothesis-driven phase I and phase II trials in prostate cancer, translating scientific discoveries to improved standards of care.
Prior to the WCG agreement, PCCTC’s trials relied on its clinical research group members’ institutional review boards (IRBs) for required protocol approval, participant consent and other documents for each study. If all 15 or a portion of them were involved in a clinical trial, each academic and non-academic center had to provide IRB approval—a situation that is reduced to just one WCG review for all the centers for each study.
“In academic research, every site has its layers of internal review that had its inconsistency and unnecessary delays,” said Jake Vinson, CEO of PCCTC, adding that in some situations, several IRBs were required to approve the protocol. “With WCG, clinical trial protocols are first reviewed by WCG and then distributed to all other centers, whereas other cancer centers will stick to their internal IRBs. However, we see WCG providing a more thorough and efficient model for reviewing prostate cancer research.”
Additionally, WCG will provide informed consent development to PCCTC members along with quality assurance that includes using the IRBs’ resources as subject matter expertise.
“We are delighted to provide PCCTC with the confidence that its research will be reviewed with the appropriate expertise and therapeutic focus, and in a timely and efficient manner,” WCG Chairman and CEO Donald Deieso, Ph.D., said in a prepared statement. The consortium is doing sterling work in exploring cutting-edge science.”
PCCTC already has conducted its first clinical study using WCG at six clinical trial cancer centers—which, Vinson added, provided efficiencies by reducing administrative delays and eliminated the redundancy of multiple uncoordinated reviews. He estimated that 40% of all the oncology clinical trial sites linked to the consortium initially will use WCG for their trials, adding that none of the other sites are required to switch. He expects, however, that more sites will turn to WCG for its better efficiencies and fewer accrual days in recruiting patients than the local IRBs.
There are other large disease-specific advocacy organizations, notably the Inner City Asthma Consortium, which operates through the University of Wisconsin (UW). That consortium is a multi-study, multicenter initiative to study the causes of the urban asthma epidemic that afflicts millions of children and to develop treatments to improve control of asthma in that population and for children in general. It has nine clinical sites located in major U.S. cities and three basic science laboratories, including one at UW-Madison.
For WCG, the partnership is important in providing a range of services to sizable clinical translational research, noted WCG Chief Medical Officer and President of Consulting Services Lindsay McNair, M.D. She said PCCTC is focused on early-stage therapies—phase I and phase II—that have the latest clinical trial designs to figure out which is the best way to move forward. WCG also has begun working with similar consortiums and with other large disease-specific advocacy organizations.
“We have seen interest from patient advocacy groups and charitable foundations working with a group of hospitals on clinical trials, such as (one involving) muscular dystrophy, where a central IRB can help launch a trial more quickly and efficiently,” said McNair. “We’ve also seen groups looking for help in informed consent writing to get it done more efficiently and making sure it is acceptable to IRBs.”
Other sizable IRBs also are taking steps to work with large disease-specific consortiums as well as patient advocacy organizations to conduct IRB reviews.
“I see this as a national trend and a groundswell moving toward greater centralized IRB reviews, as policymakers and regulators are pushing for it,” said Cami Gearhart, CEO of Quorum Review IRB. “We will see more academic medical centers and universities stepping up to ask for centralized IRBS because those IRB reviews can be done more efficiently and help facilitate getting study drugs to participants and approvals accomplished more quickly. So it’s better for all of us.”
The PCCTC Clinical Research Group is sponsored is sponsored by the Prostate Cancer Foundation and the Department of Defense Prostate Cancer Research program. Its members include the Dana-Farber Cancer Institute, Duke University Cancer Center, Johns Hopkins University Sidney Kimmel Cancer Center, University of Texas MD Anderson Cancer Center, University of Michigan Cancer Center, Memorial-Sloan Kettering Cancer Center, Oregon Health and Science University/Knight Cancer Institute, University of California-San Francisco Helen Diller Family Cancer Center, University of Washington Fred Hutchinson Cancer Research Center, UW Carbone Cancer Center, Chicago Prostate Cancer Association, Cancer Institute of New Jersey and Wayne State University Barbara Ann Karmanos Cancer Institute.
Ronald Rosenberg is a former business and science reporter for The Boston Globe. He has written features for New Scientist and Inc. magazine. His lengthy journalism career includes editing an award-winning weekly newspaper in Cornwall, N.Y. Ron also was a media relations specialist for the science faculty at Boston University, and a Knight Science Journalism Fellow at the Massachusetts Institute of Technology.
This article was reprinted from Volume 19, Issue 39, of CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »