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<p>The presence of treatment switching in randomized controlled trials may bias estimation of causal treatment effects on outcomes such as overall survival if a standard intent-to-treat analysis approach is applied. To address this, techniques from the realm of non-experimental study methodology such as two-stage estimation (TSE) have been incorporated into the clinical trialist’s toolbox. Of particular relevance to this manuscript is research exploring how TSE may be applied to settings where patients in one study arm may switch to alternative treatment so that potential bias associated with following patients after treatment switching is reduced. We contribute to the evolution of this research by extending the TSE approach so that it can appropriately account for two-arm designs where patients in both arms are allowed to switch treatments. In addition to a discussion of methodology, we have included a case study and a diversity of simulation studies supporting the statistical validity of the proposed technique.</p>

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Application of Two-Stage Estimation with Inverse Probability of Censoring Weights in Two-Arm Randomized Controlled Trials Allowing for Treatment Switching in Both Arms

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年6月25日

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  • Camden Bay,
  • Cong Li,
  • Guohui Liu,
  • Bingxia Wang,
  • Jing Xu

摘要

The presence of treatment switching in randomized controlled trials may bias estimation of causal treatment effects on outcomes such as overall survival if a standard intent-to-treat analysis approach is applied. To address this, techniques from the realm of non-experimental study methodology such as two-stage estimation (TSE) have been incorporated into the clinical trialist’s toolbox. Of particular relevance to this manuscript is research exploring how TSE may be applied to settings where patients in one study arm may switch to alternative treatment so that potential bias associated with following patients after treatment switching is reduced. We contribute to the evolution of this research by extending the TSE approach so that it can appropriately account for two-arm designs where patients in both arms are allowed to switch treatments. In addition to a discussion of methodology, we have included a case study and a diversity of simulation studies supporting the statistical validity of the proposed technique.