WCG will assist CTCA in the centralization and optimization of its regulatory and ethical review process. The improved management will allow CTCA to manage a higher volume of research while maintaining trial participant protections. CTCA focuses on cancer care with a national network of five hospitals in Atlanta, Chicago, Philadelphia, Phoenix and Tulsa.
WCG Chairman and CEO Donald Deieso told Outsourcing-Pharma.com: “One of the things we’ve observed in clinical trials in North America and the globe passing through our IRBs is that the complexity of oncology trials is growing dramatically and it reflects the advances of immunotherapy and immuno-oncology.”
WCG has experience in cancer, with a focused oncology unit, known as WCG Oncology, which is composed of industry experts and consultants, as well as three dedicated institutional review boards (IRBs).
Oncology trials are so complex that they demand that IRBs be knowledgeable and more sophisticated in understanding the science behind a trial, Deieso told us. Biobanking has become a significant issue today and it has created “a whole different set of issues with the human subject,” such as are the subjects informed and how it may or may not be used in the future, he added.
As far as CTCA, WCG began its conversation with them over a year ago, he said, noting that they’re “assuming a more prominent role in the conduct of oncological research and follows the most rigorous, industry-leading practices to assure participant safety and regulatory compliance.”
President of CTCA Medicine and Science Maurie Markman added: “To support our growth, we are adopting new practices to make the ethical and regulatory oversight of our clinical trials more efficient.”
CTCA will benefit from WCG’s guidance in the centralization and optimization of its internal IRB, which is composed of CTCA experts, and will be administered according to WCG’s standard operating procedures.
The deal comes as NIH recently announced a new policy for its grantees to promote the use of a single IRB to accelerate trials without compromising safety.
Deieso praised that move and noted that WCG looks at it “as a continuation of what we’re doing.”
Investigators are “often plagued with multi-level reviews which can lead to months-long delays,” he added.