Journal ArticleDOI
A Bayesian approach to sequential analysis in post-licensure vaccine safety surveillance.
TLDR
This paper compared the performance of the frequentist sequential method, specifically, Maximized Sequential Probability Ratio Test (MaxSPRT), and a Bayesian sequential method using simulations and a real world vaccine safety example and considers the proposed Bayesiansequential approach to be a promising alternative for vaccine safety surveillance.Abstract:
With rapid development of computing technology, Bayesian statistics have increasingly gained more attention in various areas of public health. However, the full potential of Bayesian sequential methods applied to vaccine safety surveillance has not yet been realized, despite acknowledged practical benefits and philosophical advantages of Bayesian statistics. In this paper, we describe how sequential analysis can be performed in a Bayesian paradigm in the field of vaccine safety. We compared the performance of the frequentist sequential method, specifically, Maximized Sequential Probability Ratio Test (MaxSPRT), and a Bayesian sequential method using simulations and a real world vaccine safety example. The performance is evaluated using three metrics: false positive rate, false negative rate, and average earliest time to signal. Depending on the background rate of adverse events, the Bayesian sequential method could significantly improve the false negative rate and decrease the earliest time to signal. We consider the proposed Bayesian sequential approach to be a promising alternative for vaccine safety surveillance.read more
Citations
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Journal ArticleDOI
The coronavirus disease 2019 vaccine in pregnancy: risks, benefits, and recommendations.
TL;DR: A review of maternal and neonatal coronavirus disease 2019 morbidity and mortality data along with perinatal vaccine safety considerations are presented to assist providers with shared decision-making regarding vaccine administration for this group, including the healthcare worker who is pregnant, lactating, or considering pregnancy.
Journal ArticleDOI
COVID-19 Vaccine in Pregnant and Lactating Women: A Review of Existing Evidence and Practice Guidelines.
TL;DR: In this paper, the authors summarized the available data on the efficacy and safety profile of COVID-19 vaccination in pregnant and lactating women, review the challenges of vaccine hesitancy, and include recommendations for healthcare providers.
Journal ArticleDOI
Innovative trial designs and analyses for vaccine clinical development.
TL;DR: A few vaccine trials equipped with adaptive design features, Bayesian designs that accommodate historical data borrowing, the master protocol strategy emerging during COVID-19 vaccine development, Real-World-Data (RWD) embedded trials and the correlate of protection framework and relevant research works are reviewed.
Journal ArticleDOI
Time to signal distribution of multivariate bayesian control chart with dual sampling scheme
TL;DR: The ability of a control chart to detect a shift in the process can be determined by the average run length (ARL), a widely used performance indicator for single sampling interval (SSI) control cha... as mentioned in this paper.
Bayesian Safety Surveillance with Adaptive Bias Correction
Fan Bu,Martijn J. Schuemie,Akihiko Nishimura,Louisa H. Smith,Kristin Kostka,Thomas Falconer,Jody-Ann McLeggon,Patrick B. Ryan,George Hripcsak,Marc A. Suchard +9 more
TL;DR: In this paper , a joint statistical modeling approach is proposed to estimate the effect of vaccine exposure on the adverse event of interest and correct for estimation bias by simultaneously analyzing a large set of negative control outcomes through a Bayesian hierarchical model.
References
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Journal ArticleDOI
A multiple testing procedure for clinical trials.
TL;DR: The overall size of the procedure is shown to be controlled with virtually the same accuracy as the single sample chi-square test based on N(m1 + m2) observations and the power is found to bevirtually the same.
Journal ArticleDOI
Discrete sequential boundaries for clinical trials
K. K. Gordon Lan,David L. DeMets +1 more
TL;DR: In this article, the authors proposed a more flexible method to construct discrete sequential boundaries based on the choice of a function, a*(t), which characterizes the rate at which the error level ac is spent.
Journal ArticleDOI
Group sequential methods in the design and analysis of clinical trials
TL;DR: In this article, a group sequential design is proposed to divide patient entry into a number of equal-sized groups so that the decision to stop the trial or continue is based on repeated significance tests of the accumulated data after each group is evaluated.
Journal ArticleDOI
The case for objective Bayesian analysis
TL;DR: It is suggested that the statistical community should accept formal objective Bayesian techniques with confidence, but should be more cautious about casual objectiveBayesian techniques.
Journal ArticleDOI
Interim analysis: the alpha spending function approach
David L. DeMets,K. K. G. Lan +1 more
TL;DR: The alpha spending function approach is reviewed, and its applicability to a variety of commonly used statistical procedures, including survival and longitudinal methods are detailed.
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