Global IRB WIRB-Copernicus Group (WCG) today said it will encourage the 1,200 members of its global research network to accept and use the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multicenter clinical trials.
An estimated 225 institutions have agreed to the terms of ACTA, with WCG looking to increase that number by promoting the standardized clinical trial agreement to 1,200 institutions that belong to its global research network. ACTA is designed to reduce time, costs and risks by reducing unnecessary administrative delays and inefficiencies between sponsors and healthcare institutions.
WCG’s network includes research-intensive hospitals and universities, including one-third of all U.S. academic medical centers, of which 27 already have agreed to accept ACTA without revisions.
“Last year, when we started thinking of the bottlenecks of study startup, contracting and budgeting, and looked at who is active in this area, ACTA made sense,” said Stuart Horowitz, Ph.D., president of WCG’s institutions and institutional services. “From my experience personally negotiating over 1,000 clinical trial agreements in my career and as a consultant to a hospital and an academic medical center, what I observed time and time again is that the process starts with sponsor agreements that are often, but not always, one sided. Usually, one side seeks to gain certain advantages and, typically, the medical institution counters, and then weeks and months pass by before they come to a reasonable compromise. This delay period never made sense to me.”
ACTA, which is designed to reduce contract negotiations for industry-sponsored multi-site trials, specifically in phase IIb and phase III, was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards (CTSA) program. Among the early collaborators were representatives from several pharmaceutical companies, followed by the University Industry Demonstration project. ACTA also has been reviewed by several large pharmaceutical companies, including Pfizer, Eli Lilly and Shire, according to CTSA.
Even before ACTA was conceived, data from a 2010 CTSA study showed an average clinical trial contract that took 55 days to complete could be reduced to 22 days if a “master agreement” was used, according to Petra Kaufmann, M.D., director of the NCATS Division of Clinical Innovation. NCATS is part of the National Institutes of Health.
That information prompted her organization to develop a more efficient contract that, if adopted, could help reduce delays in trial startup. The goal was to develop an unambiguous document that sets forth the regulatory and contractual obligations of both parties and presents language that may not be ideal for either party but is acceptable to both.
Horowitz said that is the essence ACTA, noting the current ACTA involves sponsors, medical centers and hospitals, but a CRO version of the ACTA will be available shortly.
Said Kaufmann, “We were pleased that WCG has recognized the potential of the ACTA and are delighted to have their support in disseminating its use.”