This paper presents a systematic methodology for the pooling and analy
sis of previously conducted epidemiologic studies. It discusses the me
thodologic issues to consider and the procedures to follow when conduc
ting a pooled analysis of individual subject level data. I review rand
om and fixed effects models to estimate pooled risks and the methods t
o examine whether heterogeneity in study-specific effect estimates exi
sts. Analytic strategies presented here can be used to assess sources
of heterogeneity, particularly those originating from different study
designs and methods. I describe methods for incorporating a qualitativ
e assessment of the study design and data collection methods into the
quantitative estimation of the overall effect. Finally, I make recomme
ndations for future pooled analyses of epidemiologic studies.