Collaboration to accelerate new clinical trial technologies and techniques for disease-focused RWE production
Clinical trial biostatistics and advanced data analytics leader Cytel Inc. joined the Massachusetts Institute of Technology Center for Biomedical Innovation’s New Drug Development Paradigms (NEWDIGS) initiative as a strategic partner.
Cytel joins NEWDIGS’s expanding and diverse list of global collaborators, which includes biopharmaceutical manufacturers, care providers, regulators, payers, health authorities, health technology assessment bodies, patient advocacy groups and other health care stakeholders. NEWDIGS provides its members with an environment, programs and practices for open, pre-competitive collaboration so they can develop solutions for systemwide impediments to biomedical innovation and patient care.
“The NEWDIGS collaboration gives us a valuable and timely opportunity to apply our expertise to an important challenge,” said Yannis Jemiai, PhD, MPH, Cytel’s Chief Scientific Officer. “For new therapies to reach their greatest potential for patient impact, we need technologies and practices that help all healthcare stakeholders, from pharmaceutical developers all the way to patients, make better decisions using better information. We look forward to helping build an innovative system to achieve this.”
Cytel initially will participate in the new Learning Ecosystems Accelerator for Patient-Centered, Sustainable Innovation (LEAPS) project’s Adaptive Point-of-Care (APoC) platform to bring prospective, real-world evidence generation into the routine patient-physician care process.APoC will examine approved Rheumatoid Arthritis treatment choices with no proven clinical distinction (i.e. clinical choices in equipoise) for insights into which provide superior performance for whom, when, and under which circumstances. The prospective APoC evidence will include not only clinical effectiveness but also metrics of patient outcomes, as well as provider and payer impact.
The APoC platform will have the capability to examine multiple questionsin appropriate patient populations through numerous prospective studies under a Core Protocol. These studies will incorporate innovative adaptive design elements, enabling faster evidence generation.The platform infrastructure, embedded at the point of clinical decision making will allow more questions to be examined at lower cost and the learnings to be continually implemented into clinical practice as they become available.
Adaptive platform trials require extensive simulation to elucidate the performance of the design in generating evidence with the uncertainties of treatment effects, patient enrollment rates, patient randomization strategies into multiple sub-studies, potential crossovers among study arms, and other factors.
“I’m excited to welcome Cytel to our unique innovation community,” said Gigi Hirsch, MD, executive director of NEWDIGS. “Cytel’s experience in such simulations for pre-authorization regulatory trials as well as its established EAST simulation software will play a critical role as LEAPS advances adaptive platforms into this real-world, ambulatory point of care setting for chronic diseases.”
As a pioneer in evidence generation, with deep expertise in advanced analytical solutions, Cytel is uniquely equipped to unlock the value from increasingly complex data. Life sciences companies count on Cytel to deliver exceptional insight, minimize trial risk, accelerate the development of promising new medicines that improve human life and unlock the value of these treatments. Cytel provides data-focused clinical research services and software solutions for the design and analysis of clinical trials, including industry standards East®, StatXact®, and LogXact®. With operations across North America, Europe, and India, Cytel employs 900 professionals, with strong talent in biostatistics, programming, data science, real-world analytics and data management. For more information about Cytel, visit https://www.cytel.com.
The NEWDrug Development ParadIGmS(NEWDIGS) Initiative at MIT is an international “think and do tank” dedicated to delivering more value faster to patients, in ways that work for all stakeholders. NEWDIGS designs, evaluates and initiates advancements that are too complex and cross-cutting to be addressed by a single organization or market sector. Its members include global leaders from patient advocacy, payer organizations, biopharmaceutical companies, regulatory agencies, clinical care, academic research and investment firms. For more information, visit http://newdigs.mit.edu.
The LEAPS Project (Learning Ecosystems Accelerator for Patient-centered, Sustainable innovation) is advancing the mission of the MIT NEWDIGS consortium—to deliver more value from biomedical innovation faster to patients, in ways that work for all stakeholders—through a new collaborative systems approach to the planning, generation, and use of evidence across R&D and healthcare delivery. A model system for Rheumatoid Arthritis is now being piloted in Massachusetts and will inform related efforts in other diseases and geographies. Success in LEAPS targets better patient outcomes while also reducing waste and inefficiency across the system.