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Incorporating estimands into clinical trial statistical analysis plans.

Minhee Kang1, Michelle A Kendall1, Heather Ribaudo1

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A new template standardizes how clinical trial estimands are presented in statistical analysis plans. This ensures alignment between trial objectives and planned analyses, improving clarity and consistency in clinical trial reporting.

Keywords:
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Area of Science:

  • Biostatistics
  • Clinical Trial Methodology
  • Pharmaceutical Research

Background:

  • The International Council for Harmonisation (ICH) E9 guideline provides principles for statistical methodology in clinical trials.
  • Addendum E9 (R1) enhanced ICH E9 by focusing on estimands and sensitivity analyses.
  • Current clinical trial protocols show variability in estimand presentation, despite E9 (R1) guidance.

Purpose of the Study:

  • To develop a standardized template for presenting estimands and their associated analyses within statistical analysis plans (SAPs).
  • To ensure alignment between clinical trial objectives, design, conduct, and analysis as per ICH E9 (R1) recommendations.
  • To provide a consistent structure for estimand presentation applicable to diverse trial designs.

Main Methods:

  • A table format was developed to create a template for SAPs, aligning statistical analysis with the estimand.
  • The template structures estimand attributes (treatment, population, variable, intercurrent events, summary) and their corresponding analysis handling.
  • The template was applied to a hypothetical pediatric HIV-1 trial and a placebo-controlled randomized trial.

Main Results:

  • The developed template effectively links estimands to planned statistical analyses.
  • Application to hypothetical trials demonstrated the template's utility in outlining objectives, populations, intercurrent events, and analysis plans.
  • The template facilitates stakeholder discussions and provides a clear overview of key trial elements.

Conclusions:

  • The proposed estimand-to-analysis table template offers a consistent and structured approach for SAPs.
  • Standardized presentation enhances clarity, facilitates reviews, and ensures alignment across trial components.
  • The template is a valuable tool for study design and improving the quality of clinical trial reporting.