Follow up after sample size re-estimation in a breast cancer randomized trial for disease-free survival.

ABSTRACT:

Background

While the clinical trials and statistical methodology literature on sample size re-estimation (SSRE) is robust, evaluation of SSRE procedures following the completion of a clinical trial has been sparsely reported. In blinded sample size re-estimation, only nuisance parameters are re-estimated, and the blinding of the current trial treatment effect is preserved. Blinded re-estimation procedures are well-accepted by regulatory agencies and funders. We review our experience of sample size re-estimation in a large international, National Institutes of Health funded clinical trial for adjuvant breast cancer treatment, and evaluate our blinded sample size re-estimation procedure for this time-to-event trial. We evaluated the SSRE procedure by examining assumptions made during

SUBMITTER: Hade EM 

PROVIDER: S-EPMC6708130 | biostudies-literature | 2019 Aug

REPOSITORIES: biostudies-literature