The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023

Richard A Parker

doi:https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07623-3

The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023

Research output: Contribution to journal › Literature review › peer-review

Abstract / Description of output

Recently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design.

Original language	English
Article number	579
Number of pages	3
Journal	Trials
Volume	24
DOIs	https://doi.org/https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07623-3 https://doi.org/10.1186/s13063-023-07623-3
Publication status	Published - 11 Sept 2023

Keywords / Materials (for Non-textual outputs)

Clinical trials
RCT
Blinding
Statisticians
Clinical trials unit

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The Unbinding_PARKER_DOA29082023_VOR_CC-BYFinal published version, 796 KBLicence: Creative Commons: Attribution (CC-BY)

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title = "The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023",

abstract = "Recently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design.",

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N1 - Funding Information: For the purpose of open access, the authors have applied a Creative Commons Attribution (CC-BY) licence to any Author Accepted Manuscript version arising from this submission. The author would like to thank the Editor for his comments, which have improved this article. Publisher Copyright: © 2023, BioMed Central Ltd., part of Springer Nature.

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Y1 - 2023/9/11

N2 - Recently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design.

AB - Recently, the Blinding of Trial Statisticians research team, Iflaifel and colleagues, have produced detailed guidance regarding the blinding or unblinding of statisticians in clinical trials, based on substantial mixed-methods work. I wish to comment on the research findings. In particular, I argue that open-label trials, non-drug trials, or non-inferiority trials should not be treated any differently from blinded superiority trials with regards to the risk of bias assessment. Prevention of bias should be the priority for definitive randomised controlled trials, regardless of the precise study design.

KW - Clinical trials

KW - RCT

KW - Blinding

KW - Statisticians

KW - Clinical trials unit

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DO - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-023-07623-3

M3 - Literature review

SN - 1745-6215

VL - 24

JO - Trials

JF - Trials

M1 - 579

ER -

The unblinding of statisticians in clinical trials: commentary on Iflaifel et al., Trials 2023

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Keywords / Materials (for Non-textual outputs)

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