Guidance published on the statistical analysis and reporting of single-arm pregnancy medication safety studies

A collaboration between ENTIS and IMI-ConcePTION partners has resulted in the publication of a series of recommendations for the statistical analysis and reporting of single-arm pregnancy medication safety studies. The aim with providing these recommendations was to improve the standardisation of pregnancy pharmacovigilance data. An open access link to a read only version of the recommendations has been provided by the publisher – see here.