Data Collection and Analysis Techniques Employed in Teratogen Surveillance Research; an exploration, trial and appraisal of the methods available to the UK Teratology Information Service
A major limitation in UKTIS’ provision of advice to health care professionals is the lack of suitable safety information concerning the risks of maternal environmental exposures during pregnancy.
For chemical exposures, available data is often completely lacking, making it impossible to provide any well-informed evidence-based advice. For medications, pregnant patients are often excluded from trials performed in the development stages prior to drug authorisation and marketing. It is therefore not until post-marketing surveillance of medication use by pregnant patients can be carried out, that the majority of pregnancy drug safety data is collected. However the conclusions which can be made from these studies often remain highly limited, primarily due to data confounding and biases introduced by research methods.
This currently ongoing PhD thesis will involve the description, trial and appraisal of two novel methods of teratogen surveillance techniques available to UKTIS. These include the collection of exposure and outcome information directly from pregnant study participants, and the interrogation of databases of electronic health care records.