The methodology of self-controlled case series studies

Stat Methods Med Res. 2009 Feb;18(1):7-26. doi: 10.1177/0962280208092342. Epub 2008 Jun 18.


The self-controlled case series method is increasingly being used in pharmacoepidemiology, particularly in vaccine safety studies. This method is typically used to evaluate the association between a transient exposure and an acute event, using only cases. We present both parametric and semiparametric models using a motivating example on MMR vaccine and bleeding disorders. We briefly describe approaches for interferent events and a sequential version of the method for prospective surveillance of drug safety. The efficiency of the self-controlled case series method is compared to the that of cohort and case control studies. Some further extensions, to long or indefinite exposures and to bivariate counts, are described.

MeSH terms

  • Biometry / methods*
  • Hepatitis B / immunology
  • Humans
  • Likelihood Functions
  • Measles-Mumps-Rubella Vaccine / adverse effects
  • Models, Statistical
  • Pharmacoepidemiology / methods*
  • Research Design*
  • Thrombocythemia, Essential / chemically induced


  • Measles-Mumps-Rubella Vaccine