The ACTA was developed by the NIH’s National Center for Advancing Translational Sciences (NCATS) to help in negotiations between institutional research sites and sponsors. The document aims to help sponsors and sites negotiate regulatory and contractual obligations in a more straightforward and unambiguous way.
Stuart Horowitz, WCG’s president of institutions and institutional services, told Outsourcing-Pharma.com that although it’s not perfect, after two years in the making, the ACTA has the potential to accelerate research.
However, the way the ACTA is currently written, it won’t work when CROs (contract research organizations) are involved, Horowitz said.
“There will be a CRO version coming out in the next week or two and we will work with our CRO partners to get that finalized,” he added.
To date, approximately 225 institutions – half of which are WCG members -- have agreed to the terms of the ACTA. As far as how many more institutions will pick up the ACTA, Horowitz said it’s tough to predict. “This is so new that it’s just in the process of being piloted… so time will tell.”
“Data from a 2010 CTSA [Clinical and Translational Science Awards] Contracts Processing Study showed that an average contract negotiation time of 55 days could be reduced to 22 days if a ‘master agreement’ was used,” said Petra Kaufmann, director of the NCATS Division of Clinical Innovation. “That information prompted us to challenge CTSA awardees to develop an efficient contract that, if adopted, could help reduce delays in trial start-up. We are pleased that WCG has recognized the potential of the ACTA, and delighted to have their support in disseminating its use.”