Dimairo, M., Stevely, A., Todd, S. et al. (4 more authors) (2015) Reporting issues in group sequential randomised controlled trials: a systematic review protocol of published journal reports. Research Report. (Unpublished)
Abstract
Background: Adaptive designs are somewhat underused, despite prominence given to methodology in the statistical literature. Some concerns relates to robustness of adaptive designs in decision making, acceptability of trial findings to change practice, anxiety about early stopping of trials and worry about wrong decision making. These issues could be linked to inadequate reporting of the conduct of such clinical trials. We assess the reporting of group sequential randomised controlled trials (RCTs), which are one of the most well-understood adaptive designs in the confirmatory setting.
Methods: We undertake a systematic review searching Ovid MEDLINE from 1st January 2001 to 23rd September 2014 and including parallel group confirmatory group sequential RCTs that were prospectively designed using the Frequentist approach. Eligible trials are screened for completeness in reporting against the CONSORT 2010 checklist with some proposed modifications to capture issues such as statistical bias correction following early stopping. Descriptive statistics aided with forest plots on CONSORT compliance are presented.
Discussion: Reporting of the conduct of adaptive designs is an area which has not been fully explored. Hence, the findings from this study can enlighten us on the adequacy in reporting of well-understood group sequential RCTs as a class of adaptive designs and on ways to address some of the cited concerns. Most importantly, the study can inform policy makers on the adequacy of the current CONSORT statements in enhancing reporting of such adaptive designs.
Metadata
Item Type: | Monograph |
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Authors/Creators: |
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Copyright, Publisher and Additional Information: | © 2015 The Author(s) |
Keywords: | Randomised Controlled Trials; Clinical Trials; Group Sequential; Interim Analyses; Adaptive Designs; Early Stopping; Phase 3; Transparency in Reporting; CONSORT |
Dates: |
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Institution: | The University of Sheffield |
Academic Units: | The University of Sheffield > Faculty of Medicine, Dentistry and Health (Sheffield) > School of Health and Related Research (Sheffield) |
Funding Information: | Funder Grant number National Institute for Health Research Doctoral Research Fellowship (DRF-2012-05-182) |
Depositing User: | Symplectic Sheffield |
Date Deposited: | 29 Oct 2015 15:08 |
Last Modified: | 25 Mar 2018 23:54 |
Status: | Unpublished |
Related URLs: | |
Open Archives Initiative ID (OAI ID): | oai:eprints.whiterose.ac.uk:88387 |