Meta-analysis of clinical trials with rare events

TY - JOUR

T1 - Meta-analysis of clinical trials with rare events

AU - Böhning, Dankmar

AU - Mylona, Kalliopi

AU - Kimber, Alan

PY - 2015/7

Y1 - 2015/7

N2 - Meta-analysis of rare event studies has recently become a subject of controversy and debate. We willargue and demonstrate in this paper that the occurrence of zero events in clinical trials or cohort studies,even if zeros occur in both arms (the case of a double-zero trial), is less problematic, at least from astatistical perspective, if the available statistical tools are applied in the appropriate way. In particular,it is neither necessary nor advisable to exclude studies with zero events from the meta-analysis. In termsof statistical tools, we will focus here on Mantel–Haenszel techniques, mixed Poisson regression andrelated regression models.

AB - Meta-analysis of rare event studies has recently become a subject of controversy and debate. We willargue and demonstrate in this paper that the occurrence of zero events in clinical trials or cohort studies,even if zeros occur in both arms (the case of a double-zero trial), is less problematic, at least from astatistical perspective, if the available statistical tools are applied in the appropriate way. In particular,it is neither necessary nor advisable to exclude studies with zero events from the meta-analysis. In termsof statistical tools, we will focus here on Mantel–Haenszel techniques, mixed Poisson regression andrelated regression models.

U2 - 10.1002/bimj.201400184

DO - 10.1002/bimj.201400184

M3 - Article

SN - 0323-3847

VL - 57

SP - 633

EP - 648

JO - Biometrical Journal: journal of mathematical methods in biosciences

JF - Biometrical Journal: journal of mathematical methods in biosciences

IS - 4

ER -