Pregnancy exposure registries: academic opportunities and industry responsibility.
Pregnancy exposure registries systematically evaluate pregnancies and outcomes exposed to a medicinal compound or device during the gestational period. Historically, such programs partner an academic institution with one or more pharmaceutical companies or are run solely by a pharmaceutical company. However, other examples abound. This article describes what a pregnancy exposure registry is, as well as selected methodological challenges they face, using real examples and applications.
Wyszynski
Diego F
DF
Amgen Inc, Global Regulatory Affairs and Safety, One Amgen Center Drive, Thousand Oaks, California 91320, USA. diegow@amgen.com
D000014:Abnormalities, Drug-Induced / Q000453:epidemiology* / Q000209:etiology; D016907:Adverse Drug Reaction Reporting Systems / Q000592:standards*; D003625:Data Collection / Q000379:methods; D016208:Databases, Factual / Q000592:standards; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D006801:Humans; D007231:Infant, Newborn; D011247:Pregnancy; D011248:Pregnancy Complications / Q000188:drug therapy*; D011256:Pregnancy Outcome; D012042:Registries / Q000592:standards*