A Bayesian approach to sequential analysis in post‐licensure vaccine safety surveillance

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.

[1]  Sander Greenland,et al.  Invited Commentary: The Need for Cognitive Science in Methodology , 2017, American journal of epidemiology.

[2]  Ruihua Yin,et al.  Monitoring the safety of quadrivalent human papillomavirus vaccine: findings from the Vaccine Safety Datalink. , 2011, Vaccine.

[3]  I R Silva,et al.  Continuous versus group sequential analysis for post‐market drug and vaccine safety surveillance , 2015, Biometrics.

[4]  M. Kulldorff,et al.  A Maximized Sequential Probability Ratio Test for Drug and Vaccine Safety Surveillance , 2011 .

[5]  J. Nelson,et al.  Post licensure surveillance of influenza vaccines in the Vaccine Safety Datalink in the 2013–2014 and 2014–2015 seasons , 2016, Pharmacoepidemiology and drug safety.

[6]  D J Spiegelhalter,et al.  The what, why and how of Bayesian clinical trials monitoring. , 1994, Statistics in medicine.

[7]  Michael Goldstein,et al.  Subjective Bayesian Analysis: Principles and Practice , 2006 .

[8]  P. O'Brien,et al.  A multiple testing procedure for clinical trials. , 1979, Biometrics.

[9]  Ivair Ramos Silva,et al.  Type I Error Probability Spending for Post-Market Drug and Vaccine Safety Surveillance With Poisson Data , 2017, Methodology and Computing in Applied Probability.

[10]  J Jack Lee,et al.  Bayesian clinical trials in action , 2012, Statistics in medicine.

[11]  D L DeMets,et al.  Interim analysis: the alpha spending function approach. , 1994, Statistics in medicine.

[12]  W Katherine Yih,et al.  An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink. , 2009, Vaccine.

[13]  Thomas R Fanshawe,et al.  A Bayesian approach to sequential meta‐analysis , 2016, Statistics in medicine.

[14]  S. Pocock.  Group sequential methods in the design and analysis of clinical trials , 1977 .

[15]  W. Satariano,et al.  A comparison of two worlds: How does Bayes hold up to the status quo for the analysis of clinical trials? , 2011, Contemporary clinical trials.

[16]  Rongxia Li,et al.  Continuous sequential boundaries for vaccine safety surveillance , 2014, Statistics in medicine.

[17]  Yuanyuan Tang,et al.  A Bayesian Meta-analysis Method for Estimating Risk Difference of Rare Events , 2018, Journal of biopharmaceutical statistics.

[18]  J. Berger.  The case for objective Bayesian analysis , 2006 .

[19]  D J Spiegelhalter,et al.  Comparison of Bayesian with group sequential methods for monitoring clinical trials. , 1989, Controlled clinical trials.

[20]  Daniel L Gillen,et al.  Bayesian evaluation of group sequential clinical trial designs , 2007, Statistics in medicine.

[21]  T. Lai,et al.  Sequential generalized likelihood ratio tests for vaccine safety evaluation , 2010, Statistics in medicine.

[22]  W Katherine Yih,et al.  Real-Time Surveillance to Assess Risk of Intussusception and Other Adverse Events After Pentavalent, Bovine-Derived Rotavirus Vaccine , 2010, The Pediatric infectious disease journal.

[23]  Jennifer C. Nelson,et al.  Statistical performance of group sequential methods for observational post-licensure medical product safety surveillance: A simulation study , 2012 .

[24]  M. Kulldorff,et al.  Absence of associations between influenza vaccines and increased risks of seizures, Guillain–Barré syndrome, encephalitis, or anaphylaxis in the 2012–2013 season , 2014, Pharmacoepidemiology and drug safety.

[25]  W Katherine Yih,et al.  Measles-Mumps-Rubella-Varicella Combination Vaccine and the Risk of Febrile Seizures , 2010, Pediatrics.

[26]  S. Greene,et al.  Signal identification and evaluation for risk of febrile seizures in children following trivalent inactivated influenza vaccine in the Vaccine Safety Datalink Project, 2010-2011. , 2012, Vaccine.

[27]  K. K. Lan,et al.  Discrete sequential boundaries for clinical trials , 1983 .