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Summary

The estimand framework, from the International Conference on Harmonisation (ICH) E9 guideline, improves clinical trial design and interpretation for hematologic oncology. It addresses challenges like complex treatments and intercurrent events in these trials.

Keywords:
ICH E9 addendumestimandhematology clinical trialsintercurrent events

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Area of Science:

  • Clinical Trials Methodology
  • Hematologic Oncology
  • Biostatistics

Background:

  • The International Conference on Harmonisation (ICH) E9 guideline addendum introduces an estimand framework.
  • This framework aids in aligning trial questions, analysis, and interpretation.
  • Hematologic malignancy trials present unique design challenges due to complex treatments and intercurrent events.

Purpose of the Study:

  • To illustrate the application of the estimand framework in hematologic clinical trials.
  • To demonstrate how the estimand framework can resolve interpretation difficulties.
  • To connect ICH E9 addendum concepts to practical applications in hematologic oncology.

Main Methods:

  • Cross-industry collaboration to apply ICH E9 addendum concepts.
  • Utilized three randomized phase 3 hematologic oncology trials for illustration.
  • Examined challenges including intercurrent events and their impact on trial design and analysis.

Main Results:

  • The estimand framework facilitates clear definition of scientific questions in complex trials.
  • It guides appropriate trial design, data collection, and analysis strategies.
  • The framework aids in consistent interpretation of clinical trial results, especially with intercurrent events.

Conclusions:

  • The estimand framework is valuable for designing and interpreting hematologic oncology trials.
  • It provides a structured approach to address complexities like treatment sequences and intercurrent events.
  • Template language is proposed for study protocols and statistical analysis plans to standardize estimand descriptions.