(237) A Landscape Analysis of Post-Marketing Studies Registered in EU PAS Register and Clinicaltrials.gov Focusing on Pregnancy Outcomes or Breastfeeding Effects: A Contribution from The ConcePTION Project

Publication Number: 568

Background: A large part of the medicine product label lacks information on safety in pregnancy and breastfeeding. To address this gap pharmaceutical companies are requested to develop post-approval studies regarding the use of drugs by pregnant and breastfeeding women. If new evidence about safety in this population is found, the pharmaceutical industry usually updates the company core data sheet which serves as the respective medicine product label.

Objectives: Our study aims to describe a landscape analysis of clinical and observational studies focusing on pregnancy and breastfeeding registered in the EU PAS register and ClinicalTrials.gov. We also aim to assess whether the findings of the completed studies led to updates of the respective product label.

Methods: Observational studies focusing on the safety evaluation of medicines used during pregnancy and breastfeeding were selected from EU PAS register and ClinicalTrials.gov. We extracted information on the variables of interest and performed an impact assessment on the respective label.

Results: A total of 141 observational studies were eligible. 63 studies (45%) were based on primary data collection and 55 studies (39%) on secondary use of health data. A small number of studies (8%) aimed to evaluate drug safety during breastfeeding. Studies with secondary use of health data included many patients (the most frequent category were between 501 and 5,000 patients). In contrast, studies using primary data collection most frequently enrolled between 101 and 500 patients. Studies using secondary data collection lasted around 2.9 years as opposed to 7.5 years duration for studies using primary data collection. Only two product labels were updated based on the results of 46 ‘completed’ studies.

Conclusions: The duration is significantly longer for studies based on primary data collection, which are also smaller in size (less power), whereas outcomes of interest are similar. In spite of the fact that a large number of studies was done, and finished, only a very low number of labels were updated based on the respective observational study. Given the gap of adequate pregnancy information in product labels, the current process of generating evidence in pregnancy and breastfeeding seems not efficient nor impactful. We recommend making better use of the existing health data across multiple databases. Ongoing consortiums such ConcePTION investigate how the power of health care sources on top of primary data collection can be best harnessed to improve the current information gap in knowledge about safety of medicines in pregnancy and breastfeeding to enhance our understanding of medication use and safety during pregnancy.