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Related Experiment Video

Updated: Dec 1, 2025

Predictive Immune Modeling of Solid Tumors

Predictive Immune Modeling of Solid Tumors

Published on: February 25, 2020

Estimand framework: Are we asking the right questions? A case study in the solid tumor setting.

Michelle Casey¹, Evgeny Degtyarev², María José Lechuga³

¹Pfizer, Inc., Collegeville, Pennsylvania, USA.

Pharmaceutical Statistics

|November 6, 2020

Summary

The estimand framework clarifies clinical trial questions by defining how to handle intercurrent events like subsequent therapy. This ensures analyses accurately reflect the intended scientific question in oncology studies.

Keywords:

EFSPI SIG estimands in oncology ICH E9 estimand intercurrent events time-to-event data

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Area of Science:

Clinical Trials Methodology
Oncology Research
Statistical Analysis in Medicine

Background:

Intercurrent events in clinical trials can complicate the interpretation of treatment effects.
Subsequent therapy initiation is a common intercurrent event in oncology, particularly before disease progression.

Purpose of the Study:

To explain the estimand framework for defining clinical questions in the presence of intercurrent events.
To illustrate how different analyses of subsequent therapy initiation address distinct scientific questions.
To guide clinical trial design, data collection, analysis, and interpretation in oncology.

Main Methods:

The study reviews the estimand framework, focusing on intercurrent events in oncology clinical trials.
It contrasts three analytical approaches for handling subsequent therapy initiation: censoring, considering events post-initiation, and treating initiation as an event.
Illustrative examples use data from renal cell carcinoma phase 3 studies.

Main Results:

Different methods for accounting for subsequent therapy yield distinct estimands, addressing different scientific questions.
The estimand framework provides clarity on whether a treatment delays recurrence with or without subsequent therapy, or delays recurrence versus initiating therapy.
The choice of estimand significantly impacts study design, data collection, analysis, and interpretation.

Conclusions:

The estimand framework is crucial for precisely defining clinical questions in oncology trials with intercurrent events.
Applying this framework ensures alignment between the research question, trial conduct, and data interpretation.
This approach enhances the scientific rigor and clarity of oncology clinical trial results.