Understanding and Mitigating Endpoint Bias in External Control Arms

Understanding and Mitigating Endpoint Bias in External Control Arms

Author: Alexander Schacht and Benjamin Piske, biometricians, statisticians and leaders in the pharma industry June 9, 2026 Duration: 28:41
External control arms are becoming increasingly important in drug development, but creating valid comparisons requires more than matching patient populations. In this episode, I speak with Ben Ackerman, Director of Real-World Biostatistics at GSK, about one of the most overlooked challenges in external control arm studies: endpoint bias. We discuss why differences in how outcomes are measured can influence study results, what researchers should consider when designing studies, and how the field is evolving to address these challenges. If you work with real-world evidence, causal inference, or innovative clinical trial designs, this episode offers valuable insights into improving the credibility and transparency of external control arm analyses.

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
Podcast Episodes
Working in an english work environment as a non-native speaker [not-audio_url] [/not-audio_url]

Duration: 12:51
In this episode, I’m diving into a topic that’s very personal to me—working in an English-speaking environment as a non-native speaker. If you’ve ever felt unsure about your English skills in meetings, emails, or present…
R-shiny - how to set it up effectively and avoid common mistakes [not-audio_url] [/not-audio_url]

Duration: 26:34
In this episode, I’m once again joined by Daniel Sabanés Bové for a deep dive into one of the most impactful tools for statisticians working with data visualization—R-Shiny. We explore how interactive data visualizations…
3 personal stories of how soft skills have helped me as a statistician [not-audio_url] [/not-audio_url]

Duration: 18:39
In this episode, I’m sharing three personal stories where soft skills—or better yet, human skills—made a huge difference in my work as a statistician. Whether it was building trust to access critical data, presenting res…
R-packages - best practices and useful tools [not-audio_url] [/not-audio_url]

Duration: 20:55
In this episode, I’m joined once again by Daniel Sabanés Bové to talk all about R packages—why they’re so useful, when to create one, and how to do it effectively. Whether you’re just starting out with writing reusable f…
Statistics and Market access - from foes to friends [not-audio_url] [/not-audio_url]

Duration: 44:23
In this episode, I welcome back Necdet Gunsoy, who’s now in a new role as the founder of EviMed, a boutique consultancy specializing in health economics, outcomes research, real-world evidence, and market access. We dive…
Beyond logic - how to convince others of your ideas [not-audio_url] [/not-audio_url]

Duration: 12:52
In this episode of The Effective Statistician podcast, I dive into the art of persuasion. As statisticians and data scientists, we often rely on logic and data, but true influence requires more than just being right. Dra…
P-value and confidence intervals - the good, the bad, and the ugly [not-audio_url] [/not-audio_url]

Duration: 32:31
In this episode of The Effective Statistician, I sit down with Kaspar Rufibach to tackle a topic that affects statisticians every day—how to interpret p-values, confidence intervals, and statistical hypotheses. We explor…
Building the Influence as a Statistician in a Clinical Trial Team [not-audio_url] [/not-audio_url]

Duration: 14:10
In this episode of The Effective Statistician, I dive into a crucial skill—building influence within a clinical trial team. As statisticians, we often need to negotiate timelines, advocate for better analysis methods, an…