Sequential case series analysis for pharmacovigilance

  title={Sequential case series analysis for pharmacovigilance},
  author={Mounia N. Hocine and Patrick Musonda and Nick J. Andrews and C. Paddy Farrington},
The self-controlled case series method is used to evaluate drug safety, particularly the safety of paediatric vaccines with respect to rare adverse reactions. We propose a group sequential version of the method for prospective surveillance of drug safety. Although the method is more widely applicable, we focus on the surveillance of new vaccines. We develop a method based on the sequential probability ratio test applied at pre-determined surveillance intervals. We investigate the properties of… CONTINUE READING