Affiliation:
1. Department of Pharmacy, School of Health Sciences, National and Kapodistrian University of Athens, 15784 Athens, Greece
2. Institute of Applied and Computational Mathematics, Foundation for Research and Technology Hellas (FORTH), 70013 Heraklion, Greece
Abstract
Sample size estimation is critical in clinical trials. A sample of adequate size can provide insights into a given population, but the collection of substantial amounts of data is costly and time-intensive. The aim of this study was to introduce a novel data augmentation approach in the field of clinical trials by employing variational autoencoders (VAEs). Several forms of VAEs were developed and used for the generation of virtual subjects. Various types of VAEs were explored and employed in the production of virtual individuals, and several different scenarios were investigated. The VAE-generated data exhibited similar performance to the original data, even in cases where a small proportion of them (e.g., 30–40%) was used for the reconstruction of the generated data. Additionally, the generated data showed even higher statistical power than the original data in cases of high variability. This represents an additional advantage for the use of VAEs in situations of high variability, as they can act as noise reduction. The application of VAEs in clinical trials can be a useful tool for decreasing the required sample size and, consequently, reducing the costs and time involved. Furthermore, it aligns with ethical concerns surrounding human participation in trials.
Subject
Fluid Flow and Transfer Processes,Computer Science Applications,Process Chemistry and Technology,General Engineering,Instrumentation,General Materials Science
Reference30 articles.
1. Sample size estimation in clinical trial;Sakpal;Perspect. Clin. Res.,2010
2. Sample Size Estimation in Clinical Research: From Randomized Controlled Trials to Observational Studies;Wang;Chest,2020
3. Fundamentals of estimating sample size;Malone;Nurse Res.,2016
4. Iliadis, A., and Macheras, P. (2016). Modeling in Biopharmaceutics, Pharmacokinetics and Pharmacodynamics. Homogeneous and Heterogeneous Approaches, Springer International Publishing. [2nd ed.].
5. European Medicines Agency, and Committee for Medicinal Products for Human Use (CHMP) (2023, May 29). Guideline on the Investigation of Bioequivalence, Available online: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-investigation-bioequivalence-rev1_en.pdf.
Cited by
13 articles.
订阅此论文施引文献
订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献