Application of sample size re-estimation in clinical trials: A systematic review.

ABSTRACT:

Background

Sample size re-estimation (SSR) is a method used to recalculate sample size during clinical trial conduct to address a lack of adequate information and can have a significant impact on study size, duration, resources, and cost. Few studies to date have summarized the conditions and circumstances under which SSR is applied. We therefore performed a systematic review of the literature related to SSR to better understand its application in clinical trial settings.

Methods

PubMed was used as the primary search source, supplemented with information from ClinicalTrials.gov where necessary details were lacking from PubMed. A systematic review was performed according to a pre-specified search strategy to identify clinical trials using SSR. Features of SSR, such as study p

SUBMITTER: Mano H 

PROVIDER: S-EPMC10568275 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature