Power prior for borrowing the real-world data in bioequivalence test with a parallel design.

The International Journal of Biostatistics
Lei HuangFangrong Yan

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.

References

Mar 1, 1976·Journal of Chronic Diseases·S J Pocock
Oct 1, 1983·Journal of Pharmaceutical Sciences·H FluehlerH A Moser
Jul 29, 2009·The New England Journal of Medicine·Richard PlattMark McClellan
Sep 8, 2009·Statistics in Medicine·Beat NeuenschwanderDavid J Spiegelhalter
Aug 6, 2013·Pharmaceutical Statistics·Kert VieleLaura Thompson
Sep 9, 2015·Statistics in Medicine·Joseph G IbrahimFang Chen
Jun 3, 2017·Pharmaceutical Statistics·Isaac GravestockUNKNOWN COMBACTE-Net consortium
Dec 19, 2017·Journal of the Royal Statistical Society. Series C, Applied Statistics·Haitao PanJielai Xia
Mar 14, 2018·Biometrical Journal. Biometrische Zeitschrift·Johanna MielkeByron Jones
Aug 15, 2018·JAMA : the Journal of the American Medical Association·Jacqueline Corrigan-CurayJanet Woodcock
Jul 16, 2019·The International Journal of Biostatistics·Shengjie LiuFangrong Yan
Aug 29, 2019·Journal of Biopharmaceutical Statistics·Jason J Z Liao, Yifang Li
Feb 18, 2020·Clinical Trials : Journal of the Society for Clinical Trials·Mark S Levenson

❮ Previous
Next ❯

Related Concepts

Trending Feeds

COVID-19

Coronaviruses encompass a large family of viruses that cause the common cold as well as more serious diseases, such as the ongoing outbreak of coronavirus disease 2019 (COVID-19; formally known as 2019-nCoV). Coronaviruses can spread from animals to humans; symptoms include fever, cough, shortness of breath, and breathing difficulties; in more severe cases, infection can lead to death. This feed covers recent research on COVID-19.

Blastomycosis

Blastomycosis fungal infections spread through inhaling Blastomyces dermatitidis spores. Discover the latest research on blastomycosis fungal infections here.

Nuclear Pore Complex in ALS/FTD

Alterations in nucleocytoplasmic transport, controlled by the nuclear pore complex, may be involved in the pathomechanism underlying multiple neurodegenerative diseases including Amyotrophic Lateral Sclerosis and Frontotemporal Dementia. Here is the latest research on the nuclear pore complex in ALS and FTD.

Applications of Molecular Barcoding

The concept of molecular barcoding is that each original DNA or RNA molecule is attached to a unique sequence barcode. Sequence reads having different barcodes represent different original molecules, while sequence reads having the same barcode are results of PCR duplication from one original molecule. Discover the latest research on molecular barcoding here.

Chronic Fatigue Syndrome

Chronic fatigue syndrome is a disease characterized by unexplained disabling fatigue; the pathology of which is incompletely understood. Discover the latest research on chronic fatigue syndrome here.

Evolution of Pluripotency

Pluripotency refers to the ability of a cell to develop into three primary germ cell layers of the embryo. This feed focuses on the mechanisms that underlie the evolution of pluripotency. Here is the latest research.

Position Effect Variegation

Position Effect Variagation occurs when a gene is inactivated due to its positioning near heterochromatic regions within a chromosome. Discover the latest research on Position Effect Variagation here.

STING Receptor Agonists

Stimulator of IFN genes (STING) are a group of transmembrane proteins that are involved in the induction of type I interferon that is important in the innate immune response. The stimulation of STING has been an active area of research in the treatment of cancer and infectious diseases. Here is the latest research on STING receptor agonists.

Microbicide

Microbicides are products that can be applied to vaginal or rectal mucosal surfaces with the goal of preventing, or at least significantly reducing, the transmission of sexually transmitted infections. Here is the latest research on microbicides.

Related Papers

Journal of the American Veterinary Medical Association
G D Koritz
European Journal of Drug Metabolism and Pharmacokinetics
J GodbillonA Sioufi
Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan
K NakaiH Ogata
Pharmaceutica acta Helvetiae
Panos Macheras, A Rosen
© 2021 Meta ULC. All rights reserved