As access to observational data and databases expands so does the need for
epidemiologists in industry. As an example, in the U.K. arm of the Departme
nt of Epidemiology at GlaxoWellcome Research and Development, the number of
PhD-trained epidemiologists increased from zero in 1996 to eight in 1999.
Their remit is often broad, including designing and co-ordinating, pharmaco
epidemiologic research, studies of risk factors for disease and disease pro
gression and pregnancy registries. Where appropriate, existing data sources
, such as research databases, are employed for studies. Otherwise, primary
data collection is pursued using standard methodology, for example, cross-s
ectional, case-control and cohort studies. This paper describes a structure
for epidemiologic research in the pharmaceutical industry, the role of the
industry epidemiologist and the scope of epidemiological studies. Two exam
ples of observational studies of HSV-2/HIV interactions are given, and impl
ications for research agendas discussed. The pharmaceutical industry is bec
oming increasingly committed to epidemiological research, and research agen
das often involve extensive collaboration with leading external academic an
d public health groups. Copyright (C) 2000 John Wiley & Sons, Ltd.