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Webinar Now Available: CTTI’s New Recommendations for Using Real-World Data Sources to Enhance Trial Quality and Efficiency

A recording is now available of the public webinar held on Thurs., Oct. 17, to launch CTTI’s new recommendations for using real-world data (RWD) to plan trial eligibility criteria and recruit participants. The webinar was led by Sudha Raman of Duke University, and Jack Sheehan of Janssen Scientific Affairs.

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 elucidate the process of integrating RWD into trial design. The case studies offer a look into the specific challenges faced by each sponsor, 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:

  • 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.
  • 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.

Both the webinar and CTTI’s latest recommendations and resources can be found on CTTI's website.