CTTI will host a public webinar on Thurs., Oct. 17, to announce new recommendations, resources, and case studies on how to use real-world data (RWD) to evaluate trial eligibility criteria and recruit potential participants.

“Until now, there have been few resources available to help sponsors and others optimally integrate the use of RWD into their trial design,” said CTTI Executive Director Pamela Tenaerts. “The work we are launching today fills that gap—our new recommendations and resources provide a clear path for using EHR and claims data to help plan eligibility criteria and recruit for clinical trials in a way that enhances quality and efficiency.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three in-depth case studies that detail the specific challenges faced by sponsors, how they used RWD to address those challenges, and what they learned along the way.

This project is one in a growing portfolio of CTTI work focused on improving quality in trials and embracing novel trial designs. Other related CTTI efforts include:

• Recommendations and a robust toolkit to help drive a Quality by Design (QbD) approach, which engages a broad range of stakeholders and focuses resources on the errors that matter to decision making.
• Co-leading a proof-of-concept study to assess the feasibility of using the FDA Sentinel System infrastructure to conduct randomized clinical trials.
• Recommendations on how to assess and design registries so that the data can meet expectations for the FDA review of new products.

The webinar is open to the public and will begin at noon ET, featuring speakers Sudha Raman, Duke University, and Jack Sheehan, Johnson & Johnson/Janssen.