Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?

Real-World Evidence vs. Randomized Trials: Can We Emulate Accuracy?

Author: Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry June 16, 2025 Duration: 52:00
In this keynote episode, Professor Sebastian Schneeweiss from Harvard Medical School shares groundbreaking insights from his extensive research into emulating randomized controlled trials (RCTs) using real-world data (RWD). Recorded live at The Effective Statistician Conference 2024, this talk explores whether non-randomized studies based on electronic health records and claims data can reach conclusions as reliable as those from traditional RCTs. Prof. Schneeweiss, also Chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital, walks us through the RCT DUPLICATE project, a major FDA-funded initiative that evaluated whether regulatory decisions could be replicated through high-quality real-world evidence (RWE). From the successes to the limitations—and everything in between—this episode is packed with lessons for statisticians, regulators, and pharmaceutical leaders interested in the future of data-driven healthcare decisions.

Hosted by Alexander Schacht and Benjamin Piske, both practicing biometricians and leaders within the pharmaceutical industry, The Effective Statistician-in association with PSI is a conversation about the practical realities of the profession. This isn't a theoretical lecture series; it's a resource built from the ground up by statisticians who navigate the same challenges you do every day. The discussions focus on actionable strategies for increasing your influence and efficiency, whether you're analyzing data, presenting findings, or guiding a team. You'll hear perspectives on developing leadership qualities even without a formal management title, and gain insight into current debates within the scientific and regulatory communities. The aim is to provide context for the health sector's evolving landscape, translating complex industry dynamics into relevant knowledge for your work. Tune in for a candid exploration of what it means to be a modern statistician, designed to help you refine your approach and achieve a more significant impact. This podcast serves as a professional toolkit, created in association with PSI (Promoting Statistical Insight), for statisticians at any career stage looking to deepen their expertise and navigate their roles with greater confidence and clarity.
Author: Language: English Episodes: 50

The Effective Statistician - in association with PSI
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