Embedding clinical trials into patient registries can lead to high-quality, efficient prospective research. However, methods for assessing which registries are appropriate to serve as the platform for the conduct of a clinical trial can be problematic for researchers. A new CTTI paper in Therapeutic Innovation & Regulatory Science identifies and describes the essential characteristics, processes, and practices required to embed and conduct registry-based clinical trials to support regulatory decision-making.
Taking an evidence-based, collaborative approach, CTTI completed a comprehensive review of registry-embedded clinical trials and worked with the Research Triangle Institute (RTI) to conduct 25 expert interviews. These efforts were followed by a multistakeholder meeting with 42 members of academia, industry, government, and patient advocacy organizations.
The resulting data indicates that registries can create a sustainable and reusable infrastructure to support embedded clinical trials when certain characteristics are present including relevancy, robustness, reliability, and assurance of patient protections.
What’s more, registry-embedded clinical trials offer opportunities to:
CTTI noted a prevailing need for guidance on how to assess the suitability of existing registries and plan new registries that can support embedded clinical trials. The paper includes CTTI recommendations, suggested practices, and decision trees that help meet this need. These resources are designed to help clinical trial stakeholders effectively leverage patient registries to create high-quality, embedded clinical trials that benefit relevant patient populations.