Real World Talk with COTA brings together healthcare leaders to discuss the importance of real world data in accelerating drug development and improving cancer care. Real World Talk is brought to you by COTA, a company that combines oncology expertise with advanced technology & analytics to create clarity from fragmented and often-inaccessible real-world data.
In the latest episode of Real World Talk, host Sandy Leonard sits down with experts Laura Fernandes and Sesh Srinivasan to dive into the pressing issue of bias in clinical research. Sandy sets the stage by highlighting recent regulatory responses and the growing attention on the topic, emphasizing its significance in the realm of real-world data and evidence.
Laura Fernandes, with her rich background at Cota and the FDA, shares an eye-opening instance where a company's oversight led to inflated tumor response data, resulting in a ripple of distrust in the community. She underscores the paramount importance of maintaining integrity in trials, ensuring that results presented are genuine and trustworthy.
Sesh, from Deloitte, offers a brighter perspective by narrating a success story about the drug Koselugo. This drug, after a lengthy 17-year development timeline, showcases the potential of external control arms in expediting drug development, emphasizing the ultimate goal: delivering effective treatments to patients faster.
20 Sept 2023
COTA Joins Aetion CARE Initiative
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.
25 Jul 2023
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.
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