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Open Comment Opportunity on CTTI’s Master Protocol Draft Resources

Amid the COVID-19 pandemic, the value of master protocol studies has become clear: we need agile clinical trials that foster collaboration to address major public health threats and ongoing research challenges. CTTI invites members from across the clinical trials ecosystem to provide feedback on its draft resources to help drive the appropriate use of master protocols in diverse therapeutic areas.

Master protocols studies have the potential to more efficiently ask and answer scientific questions – ultimately, getting the right drugs to patients more quickly. However, many organizations lack experience in running master protocol studies, presenting major study design and operational challenges.

CTTI is addressing this gap by developing publicly available resources to support sponsors, patient advocacy groups, and others that want to design a master protocol trial. Public feedback will help shape the final materials that CTTI makes available to the public this summer.

The resources, developed by experts and other stakeholders across the clinical trials ecosystem, include:

  • Master protocols roadmap
  • FDA engagement tool
  • Business & operations plan template
  • Protocol development template
  • Vendor assessment tool

Feedback is welcome until April 24 at 11:59 a.m. ET.