Oncology Trial Design Undergoes Rapid Transformation as ctDNA, MRD, and Advanced Imaging Move to Primary Endpoints
核心洞察
The Prostate Cancer Working Group (搜索) has formally redefined advanced prostate cancer (搜索) trial design, embedding PSMA PET imaging, ctDNA dynamics, and circulating tumour cells into the standard framework within the past 18 months.
Minimal residual disease (MRD) has transitioned from a translational curiosity to a decision-driving endpoint in haematological malignancies (搜索) and is now extending into solid tumours.
The FDA's Project Patient Voice is formally integrating patient-reported outcomes into regulatory thinking, while ECOG performance status scales face public challenge as inadequate for older and frail patients.
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, according to an upcoming webinar hosted by Xtalks (搜索). The session, scheduled for June 24, 2026, will examine the endpoint, eligibility, and regulatory shifts now shaping oncology trial design and how sponsors can make protocol decisions that remain relevant by readout.
The webinar arrives three weeks after ASCO 2026 and is designed for senior decision-makers across biotech and pharma who are writing oncology protocols today. Featured speakers include Dr. Victor Moreno, Director of Clinical Research Early Phase Clinical Trials at START Madrid (搜索)-FJD; Dr. Emiliano Calvo, Director of Clinical Research Early Phase Clinical Trials at START Madrid-CIOCC; and Estelle Guiheneuf, Head of Oncology at TFS HealthScience (搜索).
PCWG4 Redefines Prostate Cancer (搜索) Trial Standards
In the past 18 months, the Prostate Cancer Working Group (搜索) has formally redefined how trials in advanced prostate cancer (搜索) should be designed, embedding PSMA PET imaging, ctDNA dynamics, and circulating tumour cells into the standard trial design framework. This represents a significant departure from conventional approaches and signals a broader shift toward molecular and imaging-based endpoints across oncology.
MRD Emerges as a Decision-Driving Endpoint
Minimal residual disease has moved from a translational curiosity to a decision-driving endpoint in haematological malignancies (搜索) and is rapidly extending into solid tumours. The webinar will explore where MRD meaningfully improves decision-making versus where it risks adding unnecessary complexity, providing sponsors with a practical lens for evaluating its incorporation into protocol designs.
Regulatory Integration of Patient-Reported Outcomes
Patient-reported outcomes are being formally integrated into regulatory thinking through initiatives such as the FDA's Project Patient Voice. The session will address what regulators currently expect on patient-reported outcomes and where Project Patient Voice is heading, alongside discussion of how endpoints like Treatment-Free Survival can complement traditional measures to better capture patient benefit.
Eligibility Criteria Under Scrutiny
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. The webinar 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.
Conventional Response Criteria Falling Short
Across antibody-drug conjugates, radioligand therapies, bispecifics, and combination regimens, the conventional response criteria are increasingly inadequate to the science being tested. The session will define what "good" looks like in practice: how to design protocols that fully leverage scientific and methodological innovation while avoiding unnecessary site burden and managing regulatory risk. This includes discussion of newer design approaches and the impact of FDA Project Optimus on dose optimization.
The webinar will provide attendees with a practical framework for endpoint and eligibility decisions in 2026 oncology trials, helping sponsors evaluate whether current protocol designs are keeping pace with science and where the most consequential gaps tend to sit.