Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

Lee, T.; Kang, Seung Ho

doi:10.1080/19466315.2020.1721317

Cited by 1 publication

(2 citation statements)

References 23 publications

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“…Another extension is to use hazard based or restricted mean survival time based measures to develop BBI so that more general semiparametric or nonparametric models can be adopted. 25…”

Section: Discussionmentioning

confidence: 99%

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A Bayesian adaptive design for biosimilar trials with time‐to‐event endpoint

Belay

2021

Pharmaceutical Statistics

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A biosimilar drug is a biological product that is highly similar to and at the same time has no clinically meaningful difference from licensed product in terms of safety, purity, and potency. Biosimilar study design is essential to demonstrate the equivalence between biosimilar drug and reference product. However, existing designs and assessment methods are primarily based on binary and continuous endpoints. We propose a Bayesian adaptive design for biosimilarity trials with time-to-event endpoint. The features of the proposed design are twofold. First, we employ the calibrated power prior to precisely borrow relevant information from historical data for the reference drug. Second, we propose a two-stage procedure using the Bayesian biosimilarity index (BBI) to allow early stop and improve the efficiency. Extensive simulations are conducted to demonstrate the operating characteristics of the proposed method in contrast with some naive method. Sensitivity analysis and extension with respect to the assumptions are presented.

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“…Another extension is to use hazard based or restricted mean survival time based measures to develop BBI so that more general semiparametric or nonparametric models can be adopted. 25…”

Section: Discussionmentioning

confidence: 99%

“…Recently, Uno et al 24 proposed to use the restricted mean survival time as the primary measure of effect to improve the efficiency to assess the biosimilarity drug for breast cancer. Lee and Kang 25 proposed the three-arm parallel design for biosimilarity based on the relative distance between follow-on biologics for time-to-event endpoint.…”

mentioning

confidence: 99%

A Bayesian adaptive design for biosimilar trials with time‐to‐event endpoint

Belay

2021

Pharmaceutical Statistics

View full text Add to dashboard Cite

show abstract

Statistical Assessment of Biosimilarity Based on the Relative Distance Between Follow-on Biologics for Time-to-Event Endpoints

Cited by 1 publication

References 23 publications

A Bayesian adaptive design for biosimilar trials with time‐to‐event endpoint

A Bayesian adaptive design for biosimilar trials with time‐to‐event endpoint

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