Laura Fernandes and Sesh Srinivasan on Constructing Effective ECAs

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Summary

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.

Highlights

  • [00:00] Introduction and Overview of Real World Data – The podcast kicks off with introductions from the host and guests, followed by an overview of real-world data and its potential to transform the drug development lifecycle. They discuss the value of real-world data and hint at the exploration of ECAs in the episode.
    • “Now, throughout the series, we’ve taken a deep dive into the world of real world data, what it is, why it’s valuable, as Laura had hinted to, and how to start harnessing its potential to transform the drug development life cycle.” – Sandy Leonard
  • [02:00] Understanding External Control Arms – The guests delve into the intricacies of ECAs, discussing their types and how they differ from each other. They explain how ECAs can improve the power of analysis in clinical trials, incorporate variables not routinely captured, and enhance patient participation.
    • “Now, first off, Sesh, we’re hearing a lot about external control arms, synthetic control arms, hybrid control arms, you name it. Can you give us a lay of the land and really an overview — what do these terms mean and how do they differ from one another?” – Sandy Leonard
  • [21:00] Choosing the Right ECA Design – The conversation moves on to the selection of the right ECA design. The guests discuss the importance of clearly defining the research question and justifying the need for an ECA. They also touch upon the different ways to create an ECA depending on the disease, patient population, and current standard of care.
    • “You have to give a justification as to why you need to use an external control arm. And so now what are the different ways you could create your external control arm?” – Laura Fernandes
  • [40:00] Closing Remarks and Future Directions – The episode concludes with a discussion on the importance of real-world data in clinical trial planning and the need for clear boundaries when conducting exploratory versus regulatory grade analysis. The guests also hint at the topic of their upcoming blog post — bias in real-world data and real-world evidence.
    • “Real-world data is super helpful in the entire clinical trial planning, right? Like the whole spectrum. But just be mindful when you’re conducting exploratory versus when you’re going for that regulatory grade analysis.” – Sesh Srinivasan

Key Points

  • The Power and Potential of Real World Data. The podcast episode highlights the transformative potential of real-world data in the drug development lifecycle. Laura Fernandes and Sesh Srinivasan discuss how real-world data can be harnessed to construct External Control Arms (ECAs) in clinical trials. They emphasize the importance of clearly defining the scope and objectives of the research question, ensuring the data is relevant, reliable, complete, and timely. This insight underscores the growing significance of real-world data in advancing clinical research and improving patient outcomes.
  • The Role 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 explain how ECAs can improve the power of analysis in clinical trials, incorporate variables not routinely captured, and enhance patient participation. This insight provides a comprehensive understanding of the role and benefits of ECAs in drug development.
  • The Importance of Diversity in Clinical Trials. Sesh Srinivasan highlights the importance of diversity in clinical trials, stating that it’s not an option anymore but a critical piece. She explains how real-world data can be used to conduct feasibility studies to ensure diversity goals are met. This insight emphasizes the need for diverse representation in clinical trials to ensure the findings are applicable to a broad patient population.

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