The WIRB-Copernicus Group (WCG), a large provider of regulatory and ethical review services for clinical research, has formed WCG Oncology, a new cancer-focused institutional review board, along with the WCG Oncology Expert Advisory Board, which includes James E. Rothman, Ph.D., the 2013 recipient of the Nobel Prize in Medicine and chairman of cell biology at Yale Medical School.  

The decision to launch both the oncology IRB and the advisory board was based on evolving scientific advances that have created very promising approaches to cancer treatment and the need for a better understanding of the proper risk-benefit assessments, said Donald A. Deleso, Ph.D., WCG chairman and CEO. These advances, he said, require IRB members to possess a deep understanding of the underlying science and clinical aspects of oncology treatments.

WCG Oncology is comprised of three dedicated IRB panels that focus on the ethical oversight of oncology research with a cadre of expert oncology specialists to assist in the review of complex and scientifically-challenging research, according to a statement from WCG.

“We see oncology as one of the fastest-growing medical fields and felt we needed both an oncology IRB and an advisory board with experts who will help us with the strategic planning and education for the IRB review panel,” said Lindsay McNair, M.D., WCG chief clinical research officer. “We want to make sure they, our new oncology IRB board, are ready to review all cutting-edge oncology proposals. This also is our first advisory board for a specific medical area.”

McNair said in the past four years, WCG has reviewed more than 4,000 oncology protocols, which have substantially increased in complexity. WCG Oncology was created to stay ahead of the significant advances in gene therapy, targeted treatments and companion diagnostics and to fulfill its mission to improve and protect human health.

“For us, oncology is unique in the volume of research compared to other therapeutic areas, and while this is our first advisory board, we could, in the future and depending on the therapeutic area, start another advisory board,” she said.

Members of the WCG Oncology Advisory Board, in addition to Rothman, are:  

• John E. Niederhuber, M.D., CEO of  Inova Translational Medicine Institute and former director of the National Cancer Institute
• Arnold J. Levine, Ph.D., professor at the Institute for Advanced Study at the School of Natural Sciences and professor in the departments of pediatrics and biochemistry at the Robert Wood Johnson Medical Center
• Howard I. Scher, M.D., chief of Genitourinary Oncology Service at the Sidney Kimmel Center for Urologic and Prostate Cancers at Memorial Sloan Kettering
• John M. Falletta, M.D., pediatric oncologist and IRB chair at Duke University Medical Center and former vice chair of the Copernicus Group IRB
• George D. Demetri, M.D., director of the Ludwig Center at Harvard and senior vice president for experimental therapeutics at the Dana-Farber Cancer Institute.