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CTTI Holds First Meeting to Drive Appropriate & Efficient Use of Master Protocols

Despite a growing enthusiasm for the use of master protocol studies, expertise is critically limited and few resources exist to guide planning and implementation. Working to fill this gap, CTTI held its first Master Protocol Studies expert meeting on Oct. 22-23 to identify strategies, tools, and resources that will help drive appropriate and efficient use of master protocols.

 

Attendees discussed challenges and potential solutions to planning and running master protocol studies. They also uncovered and agreed on some important common themes:

 

  • The Value is Clear…Master protocol studies are growing in popularity. Their flexible design and highly centralized operational features have the potential to more efficiently ask and answer scientific questions.
  • …But a Roadmap is Needed…However, many organizations lack experience in running master protocol studies, presenting major study design and operational challenges.
  • …As is Support for Non-Traditional Drug Developers. Publicly available resources are needed to support organizations that want to design a master protocol trial, particularly for non-traditional drug developers such as patient advocacy groups and other nonprofits.
  • Be Excited, but Realistic. Enthusiasm for a master protocol approach should be balanced with awareness of its complex infrastructure, long-ranging timelines, and significant upfront planning and resources.
  • There are Keys to Long-Term Success. A strong cross-institutional infrastructure, including a robust site network and solid communications approach, are critical to achieving long-term sustainability of master protocols.

Based on these discussions and findings, attendees refined CTTI’s draft roadmap for the successful design and implementation of master protocol studies, and identified a broad set of tools and resources that can drive adoption of master protocols across diverse therapeutic areas.

 

Learn more about CTTI’s Master Protocol expert meeting and next steps with work to advance master protocol adoption.