Laura Fernandes and Sesh Srinivasan on Constructing Effective ECAs

In this episode of Real World Talk, Sandy Leonard from COTA hosts a thought-provoking discussion with Laura Fernandes, Senior Statistical Director at COTA, and Sesh Srinivasan, Product Management Lead at Deloitte. The conversation revolves around the future of real world data and the exploration of external control arms (ECAs) in drug development.

The guests delve into the intricacies of ECAs, discussing their types and how they differ from each other. They highlight the importance of clearly defining the scope and objectives of the research question at hand. They also shed light on the need for sponsors to consider the relevance, reliability, completeness, and timeliness of data when planning a study.

The conversation concludes with a focus on the importance of diversity in clinical trials and how real-world data can enhance patient participation and adherence. The episode provides valuable insights into the evolving landscape of real-world data in clinical trials.