CAMBRIDGE, MASSACHUSETTS—The MIT NEW Drug Development ParadIGmS (NEWDIGS) initiative, an international biomedical innovation “think and do tank”, co-hosted an “Efficacy to Effectiveness Clinical Trial” Design Lab in partnership with the Tufts Clinical Translational Science Institute (CTSI) and the new Johns Hopkins University (JHU) – Tufts Medical Center Trial Innovation Center (TIC), part of the CTSA Trial Innovation Network.
The JHU-Tufts TIC, recently funded through a $25 million NIH grant, provides high-quality design and operational support to investigators conducting multi-center clinical trials. The strategic goal is to create new frameworks and practices for clinical trials to help new treatments reach the right patients faster and in a more cost-effective way.
The Design Lab, held February 8 at the Massachusetts Institute of Technology, focused on optimizing the design of a single Efficacy to Effectiveness (E2E) clinical trial. The pharmaceutical asset at the center of the trial design may be among the first to go through the new TIC process.
Harry P. Selker, MD, MSPH, Executive Director of the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center, Dean of Tufts CTSI, and one of the new TIC’s co-leaders said, “The NEWDIGS Design Lab is a key tool for developing practices that maximize the opportunities presented by the Trial Innovation Centers. The E2E trial design developed in today’s lab will help us advance knowledge about an important treatment for patients with strokes, and potentially provide a model for future trials.”
Aims of the JHU-Tufts TIC include constructing a fully operational single Institutional Review Board and institutional master agreements within six months of the award; creating a multidisciplinary, multi-stakeholder infrastructure and processes that infuse innovations into future trials; and disseminating innovations to research trainees and trial education venues. Trials for Alzheimer’s disease and aging are among several domains that the JHU-Tufts TIC will focus on developing.
As a participant in the JHU-Tufts TIC, MIT NEWDIGS is collaborating with an established, functioning team of multi-site trial PIs, experienced lead managers, administrators, and scientists, and will be positioned to introduce new practices associated with Adaptive Biomedical Innovation (ABI). Dr. Gigi Hirsch, Executive Director of NEWDIGS and the MIT Center for Biomedical Innovation (CBI), said, “We’re proud to have earned a sub-award from the JHU-Tufts TIC and we look forward to collaborations that advance patient-centered drug development in ways that work for all stakeholders.”
About MIT NEWDIGS
MIT NEW Drug Development ParadIGmS (NEWDIGS) is an international “think and do tank” dedicated to helping biomedical innovation benefit all health care stakeholders faster and reliably. NEWDIGS designs, evaluates, and initiates advancements that are too complex and crosscutting to be addressed by a single organization or market sector. Its members include global leaders in research, development, insurance, regulation, clinical care, and patient advocacy. For more information, visit http://newdigs.mit.edu.
About the Institute for Clinical Research and Health Policy Studies (ICRHPS)
The ICRHPS at Tufts Medical Center encompasses programs in clinical and health policy research, and provides a research culture and environment that facilitates cross-disciplinary studies that will ultimately impact health and advance research methods. For over two decades, ICRHPS has generated groundbreaking studies and new approaches through work that spans biomedical and clinical sciences, behavioral and social science, community engaged research, public health studies, and health policy research. The faculty of ICRHPS is dedicated to strengthening this work through multi-disciplinary and multi-organizational collaboration.
About the Trial Innovation Network
The Trial Innovation Network is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the Trial Innovation Centers (TICs), the Recruitment Innovation Center (RIC), and the CTSA Program Hubs. The vision for the Trial Innovation Network is to innovatively address critical roadblocks in clinical trials and accelerate the translation of novel interventions into life-saving therapies. The Trial Innovation Network is a collaborative national network that focuses on operational innovation, operational excellence and collaboration and will leverage the expertise and resources of the CTSA Program. The Trial Innovation Network will feature a single IRB system, master contracting agreements, quality by design approaches, and a focus on evidence-based strategies to recruitment and patient engagement. The goal of the Trial Innovation Network is to not only execute trials better, faster, and more cost-efficiently but, importantly, to be a national laboratory to study, understand and innovate the process of conducting clinical trials.
About Tufts Clinical and Translational Science Institute (CTSI)
Tufts CTSI, a National Institutes of Health (NIH)-supported partnership among all the schools of Tufts University; Northeastern University, Brandeis University, RAND; Tufts CTSI-affiliated hospitals, and health care industry and community organizations, was established in August 2008. Its purpose is to accelerate the translation of laboratory and medical research into clinical use, widespread medical practice, and into improved health care delivery and health policy. It connects people to research resources, consultation, and education, and fosters collaboration with scholars of all disciplines and with community members, with the ultimate goal of improving the health of the public. Tufts CTSI is currently funded by the NIH National Center for Advancing Translational Sciences, award number UL1TR001064.