We propose a novel response-adaptive randomization procedure for multi-armed trials with
continuous outcomes that are assumed to be normally distributed. Our proposed rule is non …

Background: We sought to develop and validate clinically relevant, early assessment
continuous tumor measurement–based metrics for predicting overall survival (OS) using the …

Background In oncology clinical development, objective response rate, disease control rate
and early tumor size changes are commonly used as efficacy metrics for early decision …

Purpose Clinical trials using change in tumour size (CTS) as a primary end-point benefit
from earlier evaluation of treatment effect and increased study power over progression-free …

Purpose The optimal end point for randomized phase II trials of anticancer therapies
remains controversial. We simulated phase II trials by resampling patients from N9741, a …

In phase II cancer trials, tumour response is either the primary or an important secondary
endpoint. Tumour response is a binary composite endpoint determined, according to the …

We present a new adaptive dose-finding method, based on a joint modeling of longitudinal
continuous biomarker activity measurements and time to first dose limiting toxicity, with a …

Purpose Phase II clinical trials inform go/no-go decisions for proceeding to phase III trials,
and appropriate end points in phase II trials are critical for facilitating this decision. Phase II …

In many phase II trials in solid tumours, patients are assessed using endpoints based on the
Response Evaluation Criteria in Solid Tumours (RECIST) scale. Often, analyses are based …

Phase II oncology trials are carried out to assess whether an experimental anti-cancer
treatment shows sufficient signs of effectiveness to justify being tested in a phase III trial …