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April 13, 2026Open Access

Paired and AB/BA Cross-Over Design in Early Phase Clinical Trials: A Closer Look at Within-Subject Variance Bias.

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Authors

MWMartin J. WolfseggerBaxter (Austria)PXPeixin XuTakeda (United States)ACAmy CotterillCytel (United States)

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Overview

This manuscript advocates for multiple-sequence cross-over designs to address variance bias in early-phase clinical trials, suggesting better planning for studies.

Key Points

  • The research examines within-subject variance bias in paired and AB/BA cross-over designs in early-phase clinical trials.
  • Focused on paired and AB/BA cross-over design analysis.
  • Investigated estimation of random effects in early-phase trials.
  • Used data from a normally distributed variable for the analysis.
  • Identified that residual mean square error serves as an unbiased estimator under specific conditions.
  • Noted the importance of multiple-sequence designs for reducing bias.
  • Highlighted limitations of using paired and AB/BA designs for late-stage sample size calculations.

Cite This Study

Wolfsegger et al. (2026) studied this question.

synapsesocial.com/papers/69dc88d83afacbeac03ea8ddhttps://doi.org/10.17863/cam.128941
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Paired and AB / BA Cross‐Over Design in Early Phase Clinical Trials: A Closer Look at Within‐Subject Variance Bias2026
  2. 2Behavioral carry-over effect and power consideration in crossover trials2024 · 16 citations
  3. 3Penalized GEE for Complex Carry‐Over in Repeated‐Measures Crossover Designs2026
  4. 4Blinded sample size re-estimation in a crossover study2025
  5. 5Efficient minimal balanced cross-over designs in higher-order carryover effects2024 · 1 citations