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 cover three areas. First, the new endpoints, ctDNA, MRD, advanced imaging biomarkers and patient-reported outcomes, and where each genuinely strengthens decision-making rather than adding complexity. Second, the eligibility conversation, including how performance status, age and biomarker stratification are being rethought. Third, what good looks like in practice — how to build a protocol that takes advantage of the science without inflating site burden or 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.
Speakers
Victor Moreno, Director of Clinical Research Early Phase Clinical Trials, START Madrid-FJD
More info coming soon.
Message Presenter
Patricia Martínez Calle, Executive Assistant, START Center for Cancer Care
More info coming soon.
Message Presenter
Who Should Attend?
This webinar will appeal to senior professionals from biotech and pharma companies designing or running oncology trials, including:
- Chief Medical Officers
- Chief Scientific Officers
- VPs and Heads of Clinical Development
- Biostatisticians and Study Designers
- Clinical Operations Leads and Project Directors running oncology programs
- Heads of Translational Medicine
- Medical Directors and Medical Monitors with an oncology focus
- Regulatory Affairs professionals supporting oncology submissions
- Investors and BD leads evaluating early and mid-stage oncology assets
What You Will Learn
Attendees will gain insight into:
- What has formally changed in oncology trial design in the last 18 months, including PCWG4 recommendations and the ECOG performance status conversation
- How ctDNA, MRD and advanced imaging biomarkers are moving from supplementary to primary endpoints across major tumour types
- What regulators currently expect on patient-reported outcomes and where Project Patient Voice is heading
- How to evaluate whether current protocol designs are keeping pace with the science, and where the most consequential gaps tend to sit
- A practical framework for endpoint and eligibility decisions in 2026 oncology trials
Xtalks Partner
TFS HealthScience
TFS HealthScience is a full-service, global Contract Research Organization (CRO) that supports biotechnology and pharmaceutical companies throughout their entire clinical development journey. In partnership with customers, we build solution-driven teams working towards a healthier future. Bringing together nearly 800+ professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas, including Dermatology, Immunology & Inflammatory Diseases, Internal Medicine, Neuroscience, Oncology & Hematology, and Ophthalmology.
Detailed information about TFS and its business offerings can be obtained through www.tfscro.com.
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