Practical Approaches to Dose Optimisation in Oncology Trials

Early Phase Clinical Trials

This was a two-part webinar series on Practical Approaches to Dose Optimisation in Oncology Trials. This series brought together diverse perspectives to discuss optimal dosing strategies.

NIHR Statistics Group – Early Phase Clinical Trials aims to improve statistical aspects of early phase trials by identifying and promoting advanced methods that offer significant improvements. Through training and education, we aim to encourage their broader use in real-world trials.

Webinar Series: Practical Approaches to Dose Optimisation in Oncology Trials

Part 2: Industry and Regulatory Perspectives

Attendees heard from industry and regulatory agency statisticians on practical considerations, challenges, and strategies for implementing dose optimisation in oncology trials.

Session 3: Industry Statistician Perspective

Utility-Based Bayesian Method for Dose Optimisation in Oncology: U-DESPE. Implementation and Practical Considerations from Industry Perspective
Date/Time: December 11th 2025, 2-3pm GMT
Speaker: Dr Sandrine Micallef, Debiopharm, Switzerland
Chair: Aimee Jackson, Principal Statistician, Cancer Research UK Clinical Trials Unit
Sandrine Micallef is a Biostatistics Program Lead at Debiopharm, spearheading initiatives within the Biostatistics and Data Management department. Her role primarily involves defining the biostatistical strategy for oncology programs development. With over 18 years of experience, Sandrine has honed her expertise in clinical trial designs and clinical decision making, utilizing her knowledge in biostatistics, pharmacometrics, and drug development across oncology and immunology fields. She holds a PhD in Biostatistics from University Paris-Saclay, AgroParisTech. Her research focused on developing Bayesian and Modelling and simulation tools for informed decision making in the field of dose optimisation and clinical development in oncology.

Session 4: Regulatory Statistician Perspective

Considerations for Dose Optimization
Date/Time: January 13th 2026 2-3pm GMT
Speaker: Dr Joyce Cheng, FDA, USA
Chair: Dr Pavel Mozgunov, MRC Biostatistics Unit, University of Cambridge, UK
Joyce Cheng is a statistical team leader in the Division of Biometrics V for one of the teams supporting the Division of Oncology 1 at FDA. She has also been involved with OCE’s Project Optimus initiative on dosage optimization in oncology. She received her PhD in statistics from Baylor University and has been at FDA since 2015.