Many organizations face challenges in finalizing clinical trial agreements. Data from a 2010 Clinical and Translational Science Awards (CTSA) contracts processing study showed that an average contract negotiation time (exclusive of budget and IRB approval) of 55 days could be reduced to 22 days if a master agreement was used.
“This information prompted us to challenge CTSA awardees to develop an efficient contract that, if adopted, could help reduce delays in trial start-up,” said Petra Kaufmann, MD, MSc, director of the Division of Clinical Innovation at the National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH). NCATS leads the CTSA program.
UMass Medical School accepted this challenge and has adopted use of a standardized clinical trial agreement – the Accelerated Clinical Trial Agreement (ACTA) – to be used by each participating institution and sponsor to reduce contract negotiations for industry-sponsored, multi-center studies.
The ACTA is a straightforward and unambiguous document which clearly sets forth the contractual obligations of both parties, and presents language which is acceptable to both. Adoption and use of the ACTA will expedite the contract negotiation process and reduce the time it takes to start up industry-sponsored, multi-center clinical trials.
“Industry-sponsored clinical trials can provide access to cutting edge treatments”, said Katherine Luzuriaga, MD, director and PI of the UMass Center for Clinical and Translational Science, which helped develop this agreement. “Our goal is to accelerate access to clinical trials for patients and reduce overall time to drug approval.” Dr. Luzuriaga is the UMass Memorial Health Care Chair in Biomedical Research; professor of molecular medicine, pediatrics and medicine; and vice provost for clinical and translational science and global health.
To date, approximately 50 organizations representing more than 225 research sites, including academic medical centers, universities, hospitals and physician practices, have agreed to the terms of the ACTA and accept the ACTA without revision.