Data interpretation in early oncology development
Early-phase oncology trials operate under significant uncertainty. Teams must decide whether to escalate the dose, expand cohorts, or progress a program while data is still emerging. Safety, pharmacokinetics (PK), biomarkers, and early clinical data do not always align, while clinical, statistical, and operational stakeholders may view the same evidence in different ways.
In this webinar, MMS experts spanning statistical design, in-stream data interpretation, endpoint strategy, and decision architecture look at how early-phase oncology teams make and justify in-study decisions at speed when evidence is incomplete, and how to distinguish signal from noise to move forward responsibly.
Key decisions explored include:
- How statistical design and analysis planning build confidence in dose escalation and cohort expansion decisions.
- The role of early endpoints and other emerging signals in shaping in-study choices.
- How early-phase trial design and decision-making adapt when sponsors are evaluating multiple assets or indications simultaneously, including considerations for basket and multi-cohort studies.
- How in-stream visualizations and analytics support timely interpretation of evolving clinical and safety data.
- Practical considerations for aligning teams and governance around critical decisions during study conduct.
Speaker Details
Andrew Krivoshik, MD, PhD, PE
Chief Medical Officer
Mark Stewart, PhD
Vice President of Science Policy
Aiden Flynn, PhD
Senior Vice President, Strategic Statistical Services
Moderator
Ben Dudley
Chief Commercial Officer
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