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

Richard A Parker
Author Information
  1. Richard A Parker: Edinburgh Clinical Trials Unit, Usher Institute, University of Edinburgh, Edinburgh, UK. Richard.Parker@ed.ac.uk. ORCID

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.

Keywords

References

  1. Trials. 2022 Jun 27;23(1):535 [PMID: 35761345]
  2. BMJ. 1996 Jul 6;313(7048):36-9 [PMID: 8664772]
  3. PLoS One. 2010 Oct 27;5(10):e13550 [PMID: 21048948]
  4. Curr Control Trials Cardiovasc Med. 2000;1(1):19-21 [PMID: 11714400]
  5. BMJ. 2020 Jun 17;369:m115 [PMID: 32554564]
  6. Open Med. 2014 May 06;8(2):e67-72 [PMID: 25009686]
  7. Trials. 2023 Jan 31;24(1):71 [PMID: 36721215]

MeSH Term

Humans
Research Design
Research Personnel
Clinical Trials as Topic

Word Cloud

Created with Highcharts 10.0.0trialsBlindingStatisticiansresearchIflaifelunblindingstatisticiansclinicalbiasClinicalRecentlyTrialteamcolleaguesproduceddetailedguidanceregardingblindingbasedsubstantialmixed-methodsworkwishcommentfindingsparticularargueopen-labelnon-drugnon-inferioritytreateddifferentlyblindedsuperiorityregardsriskassessmentPreventionprioritydefinitiverandomisedcontrolledregardlessprecisestudydesigntrials:commentaryetalTrials2023unitRCT

Similar Articles

Cited By