VIDEO – How to build real-world evidence that survives regulatory scrutiny: A conversation with Xabier García de Albéniz, Adigens Health

As takes on a growing role in regulatory submissions, label expansions, post-authorization safety studies, and health technology assessment, the expectations placed on observational research continue to increase. Yet some studies still struggle to withstand close methodological review. Why does this happen, and what can sponsors do to avoid it?

In this interview, Xabier García de Albéniz, MD, PhD, Vice President of Science at Adigens Health, discusses the design choices that often determine whether an observational study withstands scrutiny, why many failures originate at the protocol stage, and how sponsors can generate RWE that is fit for decision-making.

Questions

• 00:00: Introduction
• 00:23: To start us off, can you tell us a bit about yourself and your role at Adigens Health?
• 01:48: You've worked both as a clinician treating patients and as a methodologist designing studies. How has that combination shaped the way you think about generating evidence that is both scientifically rigorous and clinically meaningful?
• 04:08: In your experience, where do things most commonly go wrong with RWE, and are those problems typically introduced earlier in the study design than people realize?
• 09:01: If many of these problems originate at the design stage, what are some of the key decisions sponsors should be getting right before any data are analyzed?
• 14:00: For those who aren't methodological experts, what is ‘time zero’, and why can getting it wrong undermine an otherwise well-executed study?
• 17:49: Looking ahead, what’s the one piece of advice would you give sponsors who want to generate evidence that is credible, decision-ready, and able to withstand scrutiny?

Speaker

Xabier García de Albéniz, MD, PhD
Vice President, Science, Adigens Health

Xabier, a clinical oncologist and epidemiologist, specializes in causal inference and target trial emulation applied to healthcare databases. His work focuses on evaluating cancer treatments, screening strategies, and drug safety using observational data to inform clinical and regulatory decisions. He publishes regularly in leading medical journals and is an internationally invited speaker at scientific conferences.

The opinions expressed in this feature are those of the author and do not necessarily reflect the views of The Evidence Base® or Becaris Publishing Ltd.