A systematic survey of randomised trials that stopped early for reasons of futility.

ABSTRACT:

Background

Randomised trial protocols may incorporate interim analyses, with the potential to stop the study for futility if early data show insufficient promise of a treatment benefit. Previously, we have shown that this approach will theoretically lead to mis-estimation of the treatment effect. We now wished to ascertain the importance of this phenomenon in practice.

Methods

We reviewed the methods and results in a set of trials that had stopped for futility, identified through an extensive literature search. We recorded clinical areas, interventions, study design, outcomes, trial setting, sponsorship, planned and actual treatment effects, sample sizes; power; and if there was a data safety monitoring board, or a published protocol. We identified: if interim analyses were

SUBMITTER: Walter SD 

PROVIDER: S-EPMC6966801 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature