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CTTI Unveils New Recommendations for Using Real-World Data Sources to Boost Trial Quality and Efficiency

CTTI today released new recommendations, resources, and case studies for using electronic medical records (EHRs) and claims data to plan trial eligibility criteria and recruit participants. The work fills an important gap across the clinical trials ecosystem, where the potential benefits of real-world data (RWD) have been widely acknowledged, but few resources have emerged to lead sponsors and others through the process of formally integrating RWD into their trial designs.

“We are excited to unveil this comprehensive set of work, which enables the use of RWE to plan for appropriate eligibility criteria and optimal recruitment in clinical trials,” said CTTI Executive Director Pamela Tenaerts. “These recommendations add to CTTI’s growing portfolio of work focused on improving clinical quality and, when appropriate, embracing novel approaches for better trial design and execution.”

CTTI conducted research and collaborated with stakeholders across the clinical trials ecosystem to develop these recommendations and resources, including three 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.

Other CTTI efforts related to the new work 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.

The RWD recommendations, resources, and case studies can be found on CTTI's website.