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COTA / Deloitte – data biases


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.


  • [00:00:29] Introduction to the Episode’s Theme – The episode kicks off with Sandy Leonard introducing the central theme: the impact of bias in clinical research. Sandy touches upon the recent attention the topic has garnered, especially in light of a regulatory response from a recent ODAC. The introduction sets the stage for the deep dive into the nuances of bias and its implications in real-world data and evidence.
    • “Welcome to another exciting podcast with two of my favorite real world data, real world evidence experts. Today, we’re going to be talking about what the impact is of bias in clinical research and what are some of the things that we can do to avoid it.”
  • [00:01:54] Guest Introductions and Backgrounds – Both guests, Laura and Sesh, introduce themselves, providing listeners with a glimpse into their professional backgrounds. Laura highlights her role at Cota and her previous experience at the FDA, while Sesh discusses her role at Deloitte and her background in data science and clinical trials.
    • “My name is Laura Fernandes. I work as the Senior Statistical Director here at Cota… Sesh: Sesh Srinivasan I’m from Deloitte, and I lead our life sciences R&D product strategy for Deloitte.”
  • [00:04:17] The Business Imperative of Managing Bias – Sandy emphasizes the importance of managing bias, not just for the integrity of research but also for the trustworthiness of the entire research ecosystem. She discusses the potential consequences of not managing bias, from patient outcomes to the reputation of researchers and sponsors.
    • “We have to make sure that the research that we’re putting out there altogether is trusted. And if you haven’t scientifically managed for that bias, it can not only impact the value of that evidence that gets developed, but the reputation of the researchers, the life science sponsors, the partners and the data sources that are all a part of that evidence that is coming out into the marketplace.”
  • [00:07:58] The Role of External Control Arms in Drug Development – Sesh shares a success story about the drug Koselugo and its 17-year development timeline. She highlights the potential of external control arms in accelerating drug development, especially in the context of rare diseases. The story underscores the importance of innovative approaches in bringing effective treatments to patients faster.
    • “It’s not all doom and gloom. The way you mentioned,it’s all about bringing therapy to patients faster, especially when we’re talking about rare diseases, it becomes even more important.”

Key Points

  • The Consequences of Unmanaged Bias in Research. The episode underscores the profound implications of not addressing bias in clinical research. Sandy Leonard emphasizes that unchecked bias can lead to patients receiving subpar treatment, misdiagnoses, or even delays in diagnosis. Beyond patient outcomes, the reputation of researchers, life science sponsors, and data sources can be jeopardized. Trust is paramount. If research isn’t approached with integrity and transparency, the entire ecosystem—from regulatory bodies to healthcare providers—may question its validity, leading to a loss of confidence in the presented evidence.
  • Laura’s FDA Experience: The Perils of Oversight. Laura Fernandes shares a cautionary tale from her tenure at the FDA. A company, in its application, failed to apply criteria correctly, resulting in inflated tumor response data. This oversight not only created distrust but also led to a public hearing, which could have been avoided with due diligence. Laura’s story serves as a stark reminder of the importance of accuracy and the repercussions of seemingly minor mistakes in clinical trials.
  • Sesh’s Success Story: The Power of External Control Arms. Sesh offers a beacon of hope by highlighting the drug Koselugo. Despite a prolonged 17-year development timeline, this drug, designed for a rare pediatric disease, received FDA approval. The success was partly attributed to the effective use of external control arms derived from prior clinical trials. This example showcases the potential of innovative approaches in drug development, emphasizing the importance of bringing effective treatments to patients in a timely manner.