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A systematic review of the "promising zone" design.

Abstract：

INTRODUCTION:Sample size calculations require assumptions regarding treatment response and variability. Incorrect assumptions can result in under- or overpowered trials, posing ethical concerns. Sample size re-estimation (SSR) methods investigate the validity of these assumptions and increase the sample size if necessary. The "promising zone" (Mehta and Pocock, Stat Med 30:3267-3284, 2011) concept is appealing to researchers for its design simplicity. However, it is still relatively new in the application and has been a source of controversy. OBJECTIVES:This research aims to synthesise current approaches and practical implementation of the promising zone design. METHODS:This systematic review comprehensively identifies the reporting of methodological research and of clinical trials using promising zone. Databases were searched according to a pre-specified search strategy, and pearl growing techniques implemented. RESULTS:The combined search methods resulted in 270 unique records identified; 171 were included in the review, of which 30 were trials. The median time to the interim analysis was 60% of the original target sample size (IQR 41-73%). Of the 15 completed trials, 7 increased their sample size. Only 21 studies reported the maximum sample size that would be considered, for which the median increase was 50% (IQR 35-100%). CONCLUSIONS:Promising zone is being implemented in a range of trials worldwide, albeit in low numbers. Identifying trials using promising zone was difficult due to the lack of reporting of SSR methodology. Even when SSR methodology was reported, some had key interim analysis details missing, and only eight papers provided promising zone ranges.

journal_name

Trials

journal_title

Trials

authors

Edwards JM,Walters SJ,Kunz C,Julious SA

doi

10.1186/s13063-020-04931-w

subject

Has Abstract

pub_date

2020-12-04 00:00:00

pages

1000

issue

1

issn

1745-6215

pii

10.1186/s13063-020-04931-w

journal_volume

21

pub_type

杂志文章

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