A recording is now available of the public webinar held on Tues., Oct. 13, to launch CTTI’s new set of resources that can be used to collaborate, communicate, and design master protocol studies. The webinar was led by Abby Bronson, Edgewise Therapeutics; Marianne Chase, Massachusetts General Hospital; Daniel Millar, Janssen R&D; and Nick Richardson, FDA, CDER.

While the interest in master protocol studies is growing, many organizations—particularly non-traditional drug developers such as patient advocacy groups and other nonprofits—lack the experience to design and implement this kind of study. In response to these challenges, through a high-level landscape review, a series of expert meetings, and a public open comment opportunity, CTTI developed a set of resources that include frameworks, case studies, and other interactive materials to assist in the planning and development of master protocols.

“With the success of master protocols in COVID-19 trials, there’s never been a better time to rethink the way you’re doing clinical trials in other disease areas,” said Pamela Tenaerts, executive director at CTTI. “In many cases, a well-designed and well-planned master protocol approach is an ideal way to get answers to scientific questions faster and serve patients better. Our new set of resources give sponsors, non-profit groups, and others a starting point and pathway for designing and conducting a successful master protocol study from start to finish in your disease area.”

The specific resources that CTTI released in conjunction with this webinar include:

• Value Proposition Guide: outlines key considerations for presenting the value proposition of the master protocol to stakeholders such as collaborators and vendors
• Study Simulation Tool: provides an overview of key modules that should be simulated in order to optimize master protocol design
• Protocol Development Map: describes the unique aspects of developing a master protocol from the academic or nonprofit organization perspective
• Operations Partner Assessment Tool: outlines considerations for engaging and selecting vendors as partners in master protocols
• FDA Engagement Tool: describes the formal mechanisms that facilitate early interaction with the FDA and provides a general timeline for development of an FDA engagement strategy

Both the webinar and latest resources can be found on the CTTI website.

CTTI will host a public webinar on Tues., Oct. 13 to announce new resources that provide a roadmap for designing and running master protocols.

A master protocol approach allows researchers to answer multiple scientific questions within a single clinical trial infrastructure. With a flexible design and highly centralized operational features, the master protocol platform can eliminate several challenges, resources, and expenses associated with developing and running individual protocols.

“With the success of master protocols in COVID-19 trials, there’s never been a better time to rethink the way you’re doing clinical trials in other disease areas,” said Pamela Tenaerts, executive director at CTTI. “In many cases, a well-designed and well-planned master protocol approach is an ideal way to get answers to scientific questions faster and serve patients better. Our new set of resources give sponsors, non-profit groups, and others a starting point and pathway for designing and conducting a successful master protocol study from start to finish in your disease area.”

CTTI will release a complete master protocol design and implementation roadmap, case studies, and other resources including a:

• Value Proposition Guide: outlines key considerations for presenting the value proposition of the master protocol to stakeholders such as collaborators and vendors
• Study Simulation Tool: provides an overview of key modules that should be simulated in order to optimize master protocol design
• Protocol Development Map: describes the unique aspects of developing a master protocol from the academic or nonprofit organization perspective
• Operations Partner Assessment Tool: outlines considerations for engaging and selecting vendors as partners in master protocols
• FDA Engagement Tool: describes the formal mechanisms that facilitate early interaction with the FDA and provides a general timeline for development of an FDA engagement strategy

“Due to the complexity of master protocol trials and the potential regulatory impact, a master protocol needs to be well-designed and well-conducted to ensure patient safety and quality data,” said Nicholas Richardson, clinical reviewer at the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). “This requires significant upfront planning and resources, and CTTI’s new resources outline considerations and instructions for planning and executing a successful master protocol study.”

Through a high-level landscape review, a series of expert meetings, and a public open comment opportunity, CTTI created these resources to help organizations develop well-designed master protocols and create a network to facilitate their implementation.

“We need functioning resources that address obstacles in master protocol design and how to overcome them,” said Marianne Chase, director of research operations at the Neurological Clinical Research Institute (NCRI), Massachusetts General Hospital. “With CTTI’s new offerings, we now we have a roadmap to follow—we can hit the ground running with development and, eventually, start to reap the many benefits that a master protocol approach has to offer.”

The free webinar will begin at 11 a.m. ET and will be led by Richardson; Chase; Abby Bronson, Edgewise Therapeutics; and Daniel Millar, Janssen R&D.