Towards high-quality and timely interim analyses in adaptive trials: a scoping review of best practice and evidence gaps

The currently available data suggest that although there is a considerable volume of evidence with regards to the conduct of adaptive trials and good trial management, the existing literature base offers limited specific guidance for interim analyses. There are significant gaps in the literature regarding best practice guidance related to PPIE and statistical considerations in adaptive trials. While there are examples of innovative methods speeding up the collation and analysis of data used for interim analyses, we advocate more robust research exploring the operational opportunities and challenges with regards to undertaking adaptive trials.

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Publication Details

Journal
Trials
Published
2026-03-21
DOI
https://doi.org/10.1186/s13063-026-09643-1
Primary Topic
Statistical Methods in Clinical Trials
Type
article
Field-Weighted Citation Impact
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article

Towards high-quality and timely interim analyses in adaptive trials: a scoping review of best practice and evidence gaps

Matthew Breckons, Helen Hancock, M. Dawn Teare, Helen Mossop et al.
Trials
Statistical Methods in Clinical Trials
article

Towards high-quality and timely interim analyses in adaptive trials: a scoping review of best practice and evidence gaps

Matthew Breckons, Helen Hancock, M. Dawn Teare, Helen Mossop, Katie Thomson, Michelle Bardgett, Chizoba Oparah, Julia Phillipson, Opeyemi Agbeleye, Zoë Walmsley, Alex Bevin-Nicholls, Alex Inskip, Dawn Craig, James M. S. Wason, Nina Wilson
article en

Abstract

The currently available data suggest that although there is a considerable volume of evidence with regards to the conduct of adaptive trials and good trial management, the existing literature base offers limited specific guidance for interim analyses. There are significant gaps in the literature regarding best practice guidance related to PPIE and statistical considerations in adaptive trials. While there are examples of innovative methods speeding up the collation and analysis of data used for interim analyses, we advocate more robust research exploring the operational opportunities and challenges with regards to undertaking adaptive trials.

Trials
Newcastle University (GB)
Peace, Justice and strong institutions
Openalex Percentile: Top 19%
Statistical Methods in Clinical Trials
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