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Related Experiment Video

Updated: Aug 6, 2025

Data Acquisition Protocol for Determining Embedded Sensitivity Functions

Data Acquisition Protocol for Determining Embedded Sensitivity Functions

Published on: April 20, 2016

Application of estimand framework in ICH E9 (R1) to safety evaluation.

Xuelong Wang¹, Ping Yang², Shuai S Yuan³

¹BARDS, Merck & Co, Rahway, New Jersey, USA.

Journal of Biopharmaceutical Statistics

|March 23, 2023

Summary

This study extends the estimand framework beyond efficacy to safety assessments in clinical trials. It explores applications in oncology and discusses adapting safety estimands for pandemic-related challenges like COVID-19.

Keywords:

Safety estimand framework intercurrent events oncology trial pooled data analysis

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Published on: February 1, 2020

Area of Science:

Clinical Trials Methodology
Pharmacovigilance
Biostatistics

Background:

The International Council for Harmonisation E9 (R1) guideline introduced the estimand framework to align clinical study components with research questions.
Current applications of the estimand framework primarily focus on efficacy, with limited attention to safety evaluations.
A clear definition of study objectives is crucial for the integrity and interpretation of clinical research.

Purpose of the Study:

To adapt and expand the estimand framework for safety assessments in clinical trials.
To compare and contrast the attributes of safety and efficacy estimands.
To explore the practical applications of safety estimands in oncology trials and pooled analyses, including considerations for global health events such as the COVID-19 pandemic.

Main Methods:

Review and adaptation of the existing ICH E9 (R1) estimand framework for safety contexts.
Comparative analysis of safety and efficacy estimand attributes.
Illustrative case studies and discussion of applications in oncology and pandemic scenarios.

Main Results:

The estimand framework can be effectively extended to define and structure safety assessments.
Key differences and similarities between safety and efficacy estimands were identified, highlighting the unique considerations for safety.
The framework provides a structured approach to address safety evaluation challenges, including those posed by external factors like the COVID-19 pandemic.

Conclusions:

The expanded estimand framework offers a robust methodology for defining safety objectives in clinical research.
Application of safety estimands enhances the clarity and rigor of safety evaluations, particularly in complex settings like oncology and during public health crises.
This approach supports more consistent and interpretable safety assessments across studies and populations.