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Related Concept Videos

Clinical Trials: Overview01:11

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
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These agonists bind to the IPR receptor situated on the plasma membrane of the pulmonary artery smooth muscle cells. This binding triggers a cascade of reactions known as the GS-AC-cAMP-PKA pathway. This pathway results in the relaxation of smooth muscle...

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Related Experiment Video

Updated: Jul 6, 2026

Vascular Balloon Injury and Intraluminal Administration in Rat Carotid Artery
09:41

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Published on: December 23, 2014

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Handling non-ignorable missing intimal hyperplasia data - Lessons from the VEST trial.

Jessica R Overbey1, Samantha Raymond2, Helena Chang2

  • 1Center for Biostatistics, Department of Population Health Science and Policy, Icahn School of Medicine at Mount Sinai, New York, NY, United States of America; Berry Consultants, Austin, TX, United States of America.

Contemporary Clinical Trials
|March 14, 2025
PubMed
Summary

This study introduces a new statistical method to handle missing data in clinical trials, specifically for intimal hyperplasia in coronary artery bypass graft surgery. The method ensures accurate results even when data is missing not at random.

Keywords:
Clinical trialsIntimal hyperplasiaIntravascular ultrasoundMissing dataNon-ignorable missing

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Area of Science:

  • Biostatistics
  • Clinical Trials Methodology
  • Cardiovascular Surgery Research

Background:

  • Non-ignorable missing data is a common challenge in clinical trials, particularly in studies like the VEST trial assessing saphenous vein graft outcomes.
  • Graft occlusion, leading to missing intimal hyperplasia (IH) data, is a negative outcome, making the missing data non-ignorable (missing not at random - MNAR).

Purpose of the Study:

  • To develop and evaluate a novel statistical method to address MNAR data in the VEST trial.
  • To assess the performance of this new method against existing approaches through simulation studies.

Main Methods:

  • A two-part method combining penalized multiple imputation with a modified Wilcoxon signed-rank test was developed for MNAR scenarios.
  • Simulation studies were conducted to evaluate the method's power and Type I error rate compared to alternatives.

Main Results:

  • The novel method demonstrated no Type I error inflation and adequate power under trial assumptions.
  • Power decreased with missing data exceeding 20% using double penalization due to treatment effect underestimation.
  • Penalized multiple imputation alone was more powerful for balanced missing data, while the combined method was superior for unbalanced MNAR data.

Conclusions:

  • The developed method is suitable for handling non-ignorable missing data in clinical trials, particularly in cardiovascular studies.
  • The approach is robust even when missing data is balanced across treatment arms, as observed in the VEST trial.
  • This methodology offers a valuable tool for other research settings facing similar missing data challenges.