What are RECIST 1.1 progressions made of? Variability in double-read oncology trials.

Hubert Beaumont¹, Luca Cantini², Kamal S Saini^2,3, Nathalie Faye⁴, Ritu Gill⁵, Antoine Iannessi⁴

¹Median Technologies, Valbonne, France. hubertbeaumont@hotmail.com.

²Fortrea Inc., Durham, NC, USA.

³Addenbrooke's Hospital, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK.

⁴Median Technologies, Valbonne, France.

⁵Columbia University Vagelos College of Physicians and Surgeons University Medical Center, New York, NY, USA.

PubMed PMC DOI PDF

Abstract

OBJECTIVE: Blinded Independent Central Review (BICR) with double reads and adjudication is crucial in imaging-based clinical trials to ensure quality data. However, discrepancies in double reading can affect trial outcomes, particularly in assessing disease progression in phase 3 oncology studies using RECIST 1.1 criteria. This study examined discordance in the date of progressive disease (DoPD) a…

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Create Free Account Sign In

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.