
In this free webinar, see what has formally changed in oncology trial design in the last 18 months, including PCWG4 recommendations and the ECOG performance status conversation. Attendees will gain insight into how ctDNA, MRD and advanced imaging biomarkers are moving from supplementary to primary endpoints across major tumour types. The featured speakers will discuss what regulators currently expect on patient-reported outcomes and where Project Patient Voice is heading. Attendees will learn how to evaluate whether current protocol designs are keeping pace with science, and where the most consequential gaps tend to sit. The speakers will share a practical framework for endpoint and eligibility decisions in 2026 oncology trials.
TORONTO, June 11, 2026 /PRNewswire/ -- Oncology trial design is being rewritten in real time, and protocols written even 12 months ago are starting to look out of step with where the science has moved. This webinar explores the endpoint, eligibility and regulatory shifts now shaping oncology trial design and how sponsors can make protocol decisions that remain relevant by readout.
In the past 18 months, the Prostate Cancer Working Group has formally redefined how trials in advanced prostate cancer should be designed, embedding PSMA PET imaging, ctDNA dynamics and circulating tumour cells into the standard trial design framework. Eastern Cooperative Oncology Group performance status scales, used for decades to determine trial eligibility, are being publicly challenged as inadequate for older and frail patients.
Minimal residual disease (MRD) has moved from a translational curiosity to a decision-driving endpoint in haematological malignancies and is rapidly extending into solid tumours. Patient-reported outcomes are being formally integrated into regulatory thinking through initiatives such as the FDA's Project Patient Voice. Across antibody-drug conjugates, radioligand therapies, bispecifics and combination regimens, the conventional response criteria are increasingly inadequate to the science being tested.
This webinar walks through what has actually changed across major tumour types in the last 18 months, what regulators are starting to expect and what sponsors need to know to make confident endpoint and eligibility decisions in 2026.
The session will focus on three key areas. First, it will explore evolving clinical trial design and the use of new endpoints—such as ctDNA, MRD, advanced imaging biomarkers, and patient-reported outcomes—highlighting where they meaningfully improve decision-making versus where they risk adding unnecessary complexity. This will also include discussion of how endpoints like Treatment-Free Survival (TFS) can complement traditional measures to better capture patient benefit. Second, it will address the eligibility landscape, with a particular focus on how performance status, age, and biomarker stratification are being reconsidered, alongside practical implications for patient recruitment in early-phase trials.
Third, it will define what "good" looks like in practice: how to design protocols that fully leverage scientific and methodological innovation—including newer design approaches and the impact of FDA Project Optimus on dose optimization—while avoiding unnecessary site burden and managing regulatory risk.
The webinar is timed three weeks after ASCO 2026. It is designed for senior decision-makers across biotech and pharma writing oncology protocols today.
Register for this webinar to learn how oncology trial design is changing and how stronger endpoint strategies can reduce protocol risk in 2026.
Join Dr Victor Moreno, Director of Clinical Research Early Phase Clinical Trials, START Madrid-FJD; Dr Emiliano Calvo, Director of Clinical Research Early Phase Clinical Trials, START Madrid-CIOCC; Estelle Guiheneuf, Head of Oncology, TFS HealthScience; for the live webinar on Wednesday, June 24, 2026, at 11am EDT (5pm CEST/EU-Central).
For more information, or to register for this event, visit The New Endpoints Reshaping Oncology Trial Design.
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