Estimating a treatment effect with repeated measurements accounting for varying effectiveness duration

Y. Q. Chen; J. Yang; S. Cheng; J. B. Jackson

doi:10.1093/biomet/asm019

Estimating a treatment effect with repeated measurements accounting for varying effectiveness duration

Y. Q. Chen, J. Yang, S. Cheng, J. B. Jackson

Research output: Contribution to journal › Article › peer-review

2 Scopus citations

Abstract

To assess treatment efficacy in clinical trials, certain clinical outcomes are repeatedly measured over time for the same subject. The difference in their means may characterize a treatment effect. Since treatment effectiveness lag and saturation times may exist, erosion of treatment effect often occurs during the observation period. Instead of using models based on ad hoc parametric or purely nonparametric time-varying coefficients, we model the treatment effectiveness durations, which are the time intervals between the lag and saturation times. Then we use some mean response models to include such treatment effectiveness durations. Our methodology is demonstrated by simulations and analysis of a landmark HIV/AIDS clinical trial of short-course nevirapine against mother-to-child HIV vertical transmission during labour and delivery.

Original language	English (US)
Pages (from-to)	387-402
Number of pages	16
Journal	Biometrika
Volume	94
Issue number	2
DOIs	https://doi.org/10.1093/biomet/asm019
State	Published - Jun 2007
Externally published	Yes

Bibliographical note

Funding Information:
ACKNOWLEDGEMENT We sincerely thank the editor, an associate editor, two referees and Ms. Emily Hemminger for their careful reading and invaluable comments. This research was supported in part by a federal grant from the U.S. National Institute of Allergy and Infectious Disease.

Keywords

Effect erosion
HIV/AIDS clinical trial
Longitudinal study
Mean response model
Time-varying coefficient

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1093/biomet/asm019

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AU - Chen, Y. Q.

AU - Yang, J.

AU - Cheng, S.

AU - Jackson, J. B.

N1 - Funding Information: ACKNOWLEDGEMENT We sincerely thank the editor, an associate editor, two referees and Ms. Emily Hemminger for their careful reading and invaluable comments. This research was supported in part by a federal grant from the U.S. National Institute of Allergy and Infectious Disease.

PY - 2007/6

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N2 - To assess treatment efficacy in clinical trials, certain clinical outcomes are repeatedly measured over time for the same subject. The difference in their means may characterize a treatment effect. Since treatment effectiveness lag and saturation times may exist, erosion of treatment effect often occurs during the observation period. Instead of using models based on ad hoc parametric or purely nonparametric time-varying coefficients, we model the treatment effectiveness durations, which are the time intervals between the lag and saturation times. Then we use some mean response models to include such treatment effectiveness durations. Our methodology is demonstrated by simulations and analysis of a landmark HIV/AIDS clinical trial of short-course nevirapine against mother-to-child HIV vertical transmission during labour and delivery.

AB - To assess treatment efficacy in clinical trials, certain clinical outcomes are repeatedly measured over time for the same subject. The difference in their means may characterize a treatment effect. Since treatment effectiveness lag and saturation times may exist, erosion of treatment effect often occurs during the observation period. Instead of using models based on ad hoc parametric or purely nonparametric time-varying coefficients, we model the treatment effectiveness durations, which are the time intervals between the lag and saturation times. Then we use some mean response models to include such treatment effectiveness durations. Our methodology is demonstrated by simulations and analysis of a landmark HIV/AIDS clinical trial of short-course nevirapine against mother-to-child HIV vertical transmission during labour and delivery.

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Estimating a treatment effect with repeated measurements accounting for varying effectiveness duration

Abstract

Bibliographical note

Keywords

UN SDGs

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