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32min

COTA Joins Aetion CARE Initiative


Summary

In this episode of Real World Talk, host Sandy Leonard sits down with Ulka Campbell, Head of Scientific Strategy at Aetion, and CK Wang, Chief Medical Officer at COTA. They dive into the Aetion CARE program, a cross-industry initiative aimed at understanding real-world data’s role in evaluating oncology therapeutics.

Campbell explains the importance of the CARE program, emphasizing the collaborative approach involving various stakeholders. The team is working on emulating trials, focusing on study design, data fitness, and documenting learnings. The goal is to support oncology therapeutic development, approval, and access.

Wang adds insights into the differentiation between EHR and claims data sources, highlighting the specific needs in oncology trials. The conversation concludes with a look into the future of oncology research, leaving listeners with a clear understanding of the CARE program’s significance and its potential impact on the field.

Highlights

  • [00:00:00] Introduction to Guests and the Aetion CARE Program – The episode begins with host Sandy Leonard introducing the guests and the topic of discussion: the Aetion CARE program. Ulka Campbell and CK Wang provide brief introductions about their roles and the companies they represent. The conversation sets the stage for a deeper exploration of the CARE program and its impact on oncology research.
    • “Welcome everyone to the COTA podcast, and we’re really excited today to have some guests join us here from Aetion. So my name is Sandy Leonard. I’m the chief commercial officer here at COTA and pleased to be hosting my first podcast with all of you.”
  • [00:03:00] The Multifaceted Approach of the CARE Program – Ulka Campbell delves into the CARE program’s cross-functional approach, emphasizing the collaboration with various stakeholders. She explains the process of emulating trials and the importance of understanding real-world practice in oncology therapeutics.
    • “So CARE is a cross-functional, cross-industry initiative with multiple stakeholder views represented where we are collectively trying to understand in what circumstances is real world data and observational methods best suited to emulating trials evaluating the effects of oncology therapeutics.”
  • [00:25:00] Challenges and Learnings in Real World Data Studies – Ulka Campbell discusses the challenges and learnings encountered in real-world data studies. She emphasizes the importance of transparency, rationalization, and documentation in the process, highlighting the impact these details can have on the results.
    • “The details matter. And so being fully transparent on those details, taking care to ensure that those decisions are as rationalized as possible is super important because they could have impact on the result.”
  • [00:27:00] Looking Into the Future of Oncology Research – The conversation shifts towards the future of oncology research. Sandy Leonard asks the guests to put on their “forward-thinking hats” and discuss what the success of the CARE program means for oncology research five years from now.
    • “So, you know, Ulka, I’m anticipating that CARE is going to be wildly successful. You’ll produce a lot of very important learnings. I’m curious what that means for oncology research five years from now.”

Key Points

  • The Aetion CARE Program: A Cross-Industry Initiative. The Aetion CARE program is a significant focus of the episode. Ulka Campbell explains that it’s a cross-functional, cross-industry initiative aimed at understanding how real-world data and observational methods can emulate trials for evaluating oncology therapeutics. The program began by identifying potential trials and narrowing them down based on feasibility. The team is working on emulations, focusing on study design, suitable data, and documenting both successes and challenges. The ultimate goal is to support oncology therapeutic development, approval, and access.
  • The Importance of Multidisciplinary Collaboration in Oncology Research. Campbell emphasizes the importance of a multidisciplinary approach in the CARE program. By involving stakeholders from various backgrounds, including clinical experts, the program ensures a comprehensive understanding of real-world practice. This collaboration helps in identifying what can be proxied in real-world data and what cannot, leading to more accurate and relevant findings. The episode highlights how this approach is vital for the success of the CARE program and the broader field of oncology research.
  • Differentiation Between EHR and Claims Data Sources in Oncology Trials. CK Wang provides insights into the differentiation between Electronic Health Records (EHR) and claims data sources in oncology trials. He explains that claims databases offer a transactional view into a patient’s journey, but the essential data elements for oncology trials, such as treatment response and outcomes, are contained only in clinical data. This differentiation is crucial for the CARE program, as it relies on EHR data sources for emulations, tailoring its approach specifically to oncology trials. This insight underscores the complexity and specificity required in handling data for oncology research.