Improving phase II oncology trials using best observed RECIST response as an endpoint by modelling continuous tumour measurements.

ABSTRACT: 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 on the response rate. This is the proportion of patients who have an observed tumour shrinkage above a predefined level and no new tumour lesions. The augmented binary method has been proposed to improve the precision of the estimator of the response rate. The method involves modelling the tumour shrinkage to avoid dichotomising it. However, in many trials the best observed response is used as the primary outcome. In such trials, patients are followed until progression, and their best observed RECIST outcome is used as the primary endpoint. In this paper, we propose a method that extends the augmented binary met

SUBMITTER: Lin CJ 

PROVIDER: S-EPMC5724692 | biostudies-literature | 2017 Dec

REPOSITORIES: biostudies-literature