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Trial Endpoints and Methodology

How oncology trials measure what they claim to measure: central review versus investigator assessment, cure-fraction and adaptive-dosing models, and patient-reported outcomes as an endpoint rather than a footnote.

4 articles in this topic

  • August 6, 2026JAMA Oncology

    First-Cycle PSA Math Model Predicts Who Benefits Most From Adaptive Prostate Cancer Therapy

    A first-cycle "adaptive therapy score," derived from a mathematical model of competing drug-sensitive and drug-resistant tumor cell populations, more strongly predicted time to progression than any standard PSA metric across two independent prostate cancer cohorts (n=53 total).

  • August 6, 2026JAMA OncologyPRO B Trial (DRKS00024015)

    Weekly Digital Symptom Monitoring Cuts Fatigue in Metastatic Breast Cancer

    The multicenter PRO B trial randomized 924 patients with metastatic breast cancer across 52 German centers to weekly alert-based electronic patient-reported outcome (ePRO) monitoring or usual quarterly PRO monitoring, with fatigue at 6 months as the primary endpoint.

  • July 16, 2026JAMA OncologySystematic review and trial-level meta-analysis of 21 randomized trials (no single ClinicalTrials.gov registration)

    Investigator-Assessed PFS Matches BICR in HR+/HER2-Negative Metastatic Breast Cancer

    A systematic review and trial-level meta-analysis of 21 randomized trials (9,165 pooled patients) in HR+/HER2-negative metastatic breast cancer compares investigator (local site)-assessed progression-free survival against blinded independent central review (BICR), asking whether the added cost and complexity of BICR is actually needed.

  • July 17, 2026Clinical Cancer ResearchPooled Mixture-Cure-Model Analysis of HIMALAYA (NCT03298451), CheckMate 9DW (NCT04039607), RATIONALE-301 (NCT03412773)

    Immunotherapy Achieves Durable Survival, Modest Cure Fractions in Advanced Liver Cancer

    A pooled, secondary mixture-cure-model analysis of three mature Phase III trials (HIMALAYA, CheckMate 9DW, RATIONALE-301) plus a large real-world cohort estimates how many patients with advanced hepatocellular carcinoma (HCC) achieve durable, cure-like outcomes on first-line immune checkpoint inhibitor (ICI) regimens.

Cancer types covered: Prostate Cancer · Breast Cancer · Hepatocellular Carcinoma