COTA / Deloitte - data biases
from Real World Talk with COTA
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.
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