PRINCETON, N.J., Apr. 20, 2015 – WIRB-Copernicus Group (WCG), the world's largest provider of regulatory and ethical review services for human research and a leading provider of software solutions designed to accelerate clinical trials safely, announced today that it will encourage members of its Global Research Network (GRN) to accept the Accelerated Clinical Trial Agreement (ACTA) as their default agreement for industry-sponsored, multi-center clinical trials.
The ACTA was initiated in 2012 by the National Center for Advancing Translational Sciences (NCATS) through its Clinical and Translational Science Awards (CTSA) program in collaboration with representatives from several pharmaceutical companies. NCATS is part of the National Institutes of Health. In 2014, the University Industry Demonstration Project (UIDP) joined the effort.
“All of WCG’s solutions help our clients to reduce the time, cost and risks associated with bringing new therapies to market,” said Donald A. Deieso, Ph.D., chairman and CEO of WCG. “The clinical trial process is plagued with administrative inefficiencies and unnecessary delays. We are proud to promote the hard work of the CTSAs and the UIDP, and to encourage our clients to adopt the ACTA.”
To date, approximately 225 institutions have agreed to the terms of the ACTA. WCG aims to increase that number significantly by promoting ACTA to the 1,200 institutions that belong to its GRN, which is a group comprised of research-intensive hospitals and universities, including one-third of all U.S. academic medical centers, 27 of which are CTSA institutions and have agreed to accept the ACTA without revision.
“Data from a 2010 CTSA 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, M.D., M.Sc., 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.”
The ACTA was developed to facilitate negotiations between institutional research sites and industry sponsors by creating a straightforward and unambiguous document which clearly sets forth the regulatory and contractual obligations of both parties, and presents language which – while perhaps not ideal for either party – is acceptable to both. Adoption and use of the ACTA would expedite the contract process and reduce the time it takes to start up clinical trials.
“Our institutional and sponsor clients frequently cite the contract negotiation process as a source of frustration and delay, and as a barrier to clinical trial activation,” said Stuart Horowitz, Ph.D., M.B.A., WCG’s president of institutions and institutional services. “We applaud the CTSA institutions’ effort to address this significant problem.”
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
Reaching Diverse Patient Populations With Personalized Treatment Methods
January 20th 2025Daejin Abidoye, head of solid tumors, oncology development, AbbVie, discusses a number of topics around diversity in clinical research including industry’s greatest challenges in reaching diverse patient populations, personalized treatment methods, recruitment strategies, and more.
Phase III Trial Data Show Subcutaneous Pembrolizumab as Noninferior to IV Keytruda
March 31st 2025Subcutaneous administration of pembrolizumab with chemotherapy demonstrated a nearly 50% reduction in patient chair and treatment room time while maintaining efficacy and safety endpoints compared to intravenous Keytruda.
Phase II ALPACA Trial Shows Lepodisiran Produces Significant, Sustained Lipoprotein(a) Reductions
March 31st 2025Eli Lilly’s lepodisiran, an investigational siRNA therapy, achieved significant and durable reductions in lipoprotein(a) levels, a major genetic risk factor for cardiovascular disease.