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Purpose of Review <p>To review and assess current design approaches in endoscopic mucosal resection (EMR) trials, identify areas where traditional methodologies may limit relevance or generalizability, and propose a forward-looking framework that incorporates methodological innovations aligned with clinical and stakeholder priorities.</p> Recent Findings <p>Despite major procedural advances in EMR, trial design has evolved more slowly – employing binary endpoints, limited patient and clinician input, and enrollment models often led by high-volume proceduralists. Critical design innovations, such as ordinal recurrence classifications, composite outcomes ranked by clinical severity, and proceduralist-aware statistical models can help to overcome these limitations. Introducing methodology such as generalized pairwise comparisons yielding a win ratio, while useful for analyzing hierarchical composite endpoints (HCEs), represent just one facet of a broader strategy. Drawing from innovations in cardiovascular and other procedural disciplines, this review highlights how diverse design elements can be adapted to the EMR space.</p> Summary <p>Improving EMR trials demands a shift in trial architecture. By combining stakeholder-informed outcome hierarchies, advanced analytic methods, and strategies to mitigate operator bias, a modern framework capable of producing more meaningful, reproducible, and generalizable evidence is possible. This evolution in design reflects a necessary progression for procedural trials and sets the stage for a new standard in colorectal polyp resection research.</p>

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Of Endpoints and Equipoise: Reforming Clinical Trials in Colorectal Polyp Resection

  • 期刊论文

  • 发表日期：

    2025年9月18日

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  • Zachary L. Smith,
  • Nauzer Forbes,
  • Srivats Madhavan,
  • Heiko Pohl,
  • Jacob M. Schauer,
  • Ingo Steinbrück,
  • Daniel von Renteln

摘要

Purpose of Review

To review and assess current design approaches in endoscopic mucosal resection (EMR) trials, identify areas where traditional methodologies may limit relevance or generalizability, and propose a forward-looking framework that incorporates methodological innovations aligned with clinical and stakeholder priorities.

Recent Findings

Despite major procedural advances in EMR, trial design has evolved more slowly – employing binary endpoints, limited patient and clinician input, and enrollment models often led by high-volume proceduralists. Critical design innovations, such as ordinal recurrence classifications, composite outcomes ranked by clinical severity, and proceduralist-aware statistical models can help to overcome these limitations. Introducing methodology such as generalized pairwise comparisons yielding a win ratio, while useful for analyzing hierarchical composite endpoints (HCEs), represent just one facet of a broader strategy. Drawing from innovations in cardiovascular and other procedural disciplines, this review highlights how diverse design elements can be adapted to the EMR space.

Summary

Improving EMR trials demands a shift in trial architecture. By combining stakeholder-informed outcome hierarchies, advanced analytic methods, and strategies to mitigate operator bias, a modern framework capable of producing more meaningful, reproducible, and generalizable evidence is possible. This evolution in design reflects a necessary progression for procedural trials and sets the stage for a new standard in colorectal polyp resection research.