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Weak blinding in medical trials can cause activated expectancy bias (AEB), skewing results. A new tool, the Correct Guess Rate Curve (CGRC), helps estimate true treatment effects by accounting for this bias.

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Area of Science:

  • Clinical trial methodology
  • Psychopharmacology
  • Computational modeling

Background:

  • Blinding in medical trials aims to equalize expectancy effects but often fails.
  • Weak blinding combined with positive treatment expectancy can create uneven expectancy effect distribution.

Purpose of the Study:

  • To demonstrate how weak blinding leads to activated expectancy bias (AEB).
  • To introduce the Correct Guess Rate Curve (CGRC) as a statistical tool to counteract AEB.
  • To re-analyze the psychedelic microdose trial data to show AEB's impact.

Main Methods:

  • Computational modeling to simulate expectancy effects under weak blinding.
  • Development and application of the Correct Guess Rate Curve (CGRC).
  • Re-analysis of empirical data from a self-blinding psychedelic microdose trial.

Main Results:

  • Activated expectancy bias (AEB) can inflate treatment effect estimates and yield false positives.
  • The CGRC can estimate perfectly blinded trial outcomes from imperfectly blinded data.
  • Psychedelic microdosing trial results suggest placebo-microdose differences may be AEB-driven false positives, indicating microdosing acts as an active placebo.

Conclusions:

  • Distinguishes between trials with placebo controls and genuinely placebo-controlled trials.
  • Highlights the risk of false positive findings due to AEB in imperfectly blinded studies.
  • Recommends adoption of a new blinding integrity assessment tool compatible with CGRC.