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Estimation of the Restricted Mean Duration of Response (RMDoR) in Oncology.

Antonios Daletzakis^1,2, Kit C B Roes², Marianne A Jonker²

¹Biometrics Department, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Pharmaceutical Statistics

|February 7, 2025

Summary

This summary is machine-generated.

Restricted mean duration of response (RMDoR) is a useful measure for treatment efficacy, especially when dealing with censored data. This study explores RMDoR estimation methods for interval-censored data in clinical trials.

Keywords:

interval censoring progression of the disease response to treatment restricted mean duration of response survival analysis

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Area of Science:

Biostatistics
Clinical Trial Methodology
Health Economics

Background:

Duration of Response (DoR) is a key efficacy endpoint in clinical trials.
Estimating DoR is challenging due to right-censored patient follow-up times.
Restricted Mean Duration of Response (RMDoR) is an alternative estimand often used in practice.

Purpose of the Study:

To evaluate the behavior of RMDoR as a function of time.
To assess the suitability of RMDoR for quantifying treatment efficacy.
To develop and compare estimators for RMDoR with interval-censored data.

Main Methods:

The study considers RMDoR as a function of a specified time interval.
Multiple statistical estimators are proposed to handle interval-censored data.
The performance of these estimators is evaluated in both single-arm and randomized controlled trial settings.

Main Results:

The behavior of RMDoR as a function of time is analyzed.
The study presents novel estimators for RMDoR accounting for interval censoring.
Performance evaluation of estimators provides insights into their reliability.

Conclusions:

RMDoR is a valuable measure for treatment efficacy, particularly when direct DoR estimation is difficult.
The proposed estimators offer robust methods for analyzing interval-censored data in oncology trials.
This work contributes to improved statistical practices in clinical trial analysis.