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. You are invited to review and provide comments on draft resources created by the Clinical Trials Transformation Initiative (CTTI) to help drive the appropriate use of master protocols in diverse therapeutic areas. The resources include:
• Master protocols roadmap
• FDA engagement tool
• Business & operations plan template
• Protocol development template
• Vendor assessment tool
As an important member of the clinical trials ecosystem, your feedback is important – please suggest revisions or additions to our draft resources by next Friday, April 24 at 11:59 p.m. ET. Your feedback will help shape the final materials that we make available to the public this summer.
Other important information:
• The open comment opportunity is only available in English.
• You may provide comments as an individual or an organization.
• There is no compensation.