Power prior for borrowing the real-world data in bioequivalence test with a parallel design
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Lei Huang
Abstract
Recently, real-world study has attracted wide attention for drug development. In bioequivalence study, the reference drug often has been marketed for many years and accumulated abundant real-world data. It is therefore appealing to incorporate these data in the design to improve trial efficiency. In this paper, we propose a Bayesian method to include real-world data of the reference drug in a current bioequivalence trial, with the aim to increase the power of analysis and reduce sample size for long half-life drugs. We adopt the power prior method for incorporating real-world data and use the average bioequivalence posterior probability to evaluate the bioequivalence between the test drug and the reference drug. Simulations were conducted to investigate the performance of the proposed method in different scenarios. The simulation results show that the proposed design has higher power than the traditional design without borrowing real-world data, while controlling the type I error. Moreover, the proposed method saves sample size and reduces costs for the trial.
Funding source: National Natural Science Foundation of China
Award Identifier / Grant number: 81973145
Funding source: The “Double First-Class” University project
Award Identifier / Grant number: CPU2018GY09
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Author contribution: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
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Research funding: The research is funded by the National Natural Science Foundation of China (81973145) and the “Double First-Class” University project (CPU2018GY09).
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Conflict of interest statement: The authors declare no conflicts of interest regarding this article.
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© 2021 Walter de Gruyter GmbH, Berlin/Boston
Artikel in diesem Heft
- Frontmatter
- Research Articles
- Integrating additional knowledge into the estimation of graphical models
- Asymptotic properties of the two one-sided t-tests – new insights and the Schuirmann-constant
- Bayesian optimization design for finding a maximum tolerated dose combination in phase I clinical trials
- A Bayesian mixture model for changepoint estimation using ordinal predictors
- Power prior for borrowing the real-world data in bioequivalence test with a parallel design
- Bayesian approaches to variable selection: a comparative study from practical perspectives
- Bayesian adaptive design of early-phase clinical trials for precision medicine based on cancer biomarkers
- More than one way: exploring the capabilities of different estimation approaches to joint models for longitudinal and time-to-event outcomes
- Designing efficient randomized trials: power and sample size calculation when using semiparametric efficient estimators
- Power formulas for mixed effects models with random slope and intercept comparing rate of change across groups
- The effect of data aggregation on dispersion estimates in count data models
- A zero-inflated non-negative matrix factorization for the deconvolution of mixed signals of biological data
- Multiple scaled symmetric distributions in allometric studies
- Estimation of semi-Markov multi-state models: a comparison of the sojourn times and transition intensities approaches
- Regularized bidimensional estimation of the hazard rate
- The effect of random-effects misspecification on classification accuracy
- The area under the generalized receiver-operating characteristic curve
Artikel in diesem Heft
- Frontmatter
- Research Articles
- Integrating additional knowledge into the estimation of graphical models
- Asymptotic properties of the two one-sided t-tests – new insights and the Schuirmann-constant
- Bayesian optimization design for finding a maximum tolerated dose combination in phase I clinical trials
- A Bayesian mixture model for changepoint estimation using ordinal predictors
- Power prior for borrowing the real-world data in bioequivalence test with a parallel design
- Bayesian approaches to variable selection: a comparative study from practical perspectives
- Bayesian adaptive design of early-phase clinical trials for precision medicine based on cancer biomarkers
- More than one way: exploring the capabilities of different estimation approaches to joint models for longitudinal and time-to-event outcomes
- Designing efficient randomized trials: power and sample size calculation when using semiparametric efficient estimators
- Power formulas for mixed effects models with random slope and intercept comparing rate of change across groups
- The effect of data aggregation on dispersion estimates in count data models
- A zero-inflated non-negative matrix factorization for the deconvolution of mixed signals of biological data
- Multiple scaled symmetric distributions in allometric studies
- Estimation of semi-Markov multi-state models: a comparison of the sojourn times and transition intensities approaches
- Regularized bidimensional estimation of the hazard rate
- The effect of random-effects misspecification on classification accuracy
- The area under the generalized receiver-operating characteristic curve
