Dear Fellow Statisticians,
We are pleased to announce an exciting upcoming seminar as part of the ISBS Webinar Series on clinical trial innovation. The seminar, titled "The Patient Voice in Focus: Advancing Early Phase Oncology Trials Through PRO-Driven Innovation," will be held on April 24, 2026, 11:00 AM–12:00 PM EST, featuring distinguished speaker Prof. Christina Yap from the ICR Clinical Trials & Statistics Unit (ICR-CTSU).
Abstract:
Patient-reported outcomes (PROs) are increasingly recognized as critical for assessing tolerability in early phase dose-finding oncology trials (DFOTs). However, PRO objectives are often poorly specified, and their analysis and reporting remain variable and frequently misaligned with trial aims. The OPTIMISE (incOrporating PaTIent-reported outcoMes In doSE-finding trials) programme addresses this gap through two complementary practical resources.
OPTIMISE ROR (Research Objectives Recommendations) provides international consensus-driven guidance on defining PRO research objectives centered on symptomatic adverse events, overall side effect impact, and health-related quality of life.
OPTIMISE AR (Analysis Recommendations) offers a practical toolkit outlining recommended analytical and visualization approaches for PRO data across key DFOT objectives, covering endpoints across timepoints, between timepoints, time-to-event PRO endpoints, and PRO-informed summaries for interim and final dose decision-making.
In parallel, emerging PRO-informed adaptive dose-finding designs illustrate how PRO data can directly inform escalation, de-escalation, and final dose selection.
U-PRO CRM (Utility PRO Continual Reassessment Method) integrates both clinician-reported and patient-reported toxicity into model-based escalation, while PRO-ADD (PROs Aided Dose-escalation Design) shifts the paradigm from identifying a maximum tolerated dose to selecting an optimal dose through a modular framework that incorporates safety, PRO-derived tolerability, and preliminary efficacy. These approaches support patient-centered dose optimization for modern oncology therapies.
Together, these developments provide a coherent methodological pathway for integrating PROs into DFOTs, linking clearly defined objectives to appropriate analytical strategies and adaptive designs that enable PROs to actively inform dose-finding and dose-optimization.
Registration Details:
Please join using the following link:
https://us06web.zoom.us/j/85999511123?pwd=g5FkTJ81ZAt36viuwN9qjaU01x6ihq.1
We look forward to your participation in this thought-provoking seminar!
We look forward to your participation on April 24, 2026!
Best regards,
Haitao Pan
St. Jude Children's Research Hospital
On behalf of ISBS Webinar Committee
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Haitao Pan
Associate Professor
St. Jude Children's Research Hospital
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