Descriptive Pregnancy Safety Study using PRIM model

Pregnancy safety evaluations for products with low anticipated exposure often require alternative approaches to traditional pregnancy registries. To support post-marketing safety commitments, ICON implements the Pregnancy Outcome Intensive Monitoring (PRIM) approach, whereby data on exposed pregnancies are collected through enhanced pharmacovigilance processes.

As a form of secondary use of pharmacovigilance data, PRIM leverages pregnancy exposure reports received through routine safety surveillance activities and supplements them with structured follow-up to collect pregnancy and infant outcomes. This methodology enables efficient identification, follow-up, and evaluation of exposed pregnancies while generating meaningful real-world evidence.

By building on existing pharmacovigilance infrastructure, PRIM offers a pragmatic, scalable, and cost-efficient approach to pregnancy safety monitoring, particularly in settings where traditional registry recruitment may be challenging. It supports long-term evidence generation while minimizing operational burden and enabling broad geographic reach.

The sponsor needed to generate pregnancy safety evidence in a rare disease population characterized by very low exposure rates. The program required a scientifically robust and regulator-ready approach capable of supporting Health Authority interactions, ensuring comprehensive follow-up of reported pregnancies, and maintaining strong governance throughout the study lifecycle.

A scalable and operationally efficient model was needed to maximise case capture, support long-term monitoring, and generate meaningful evidence despite the challenges associated with limited pregnancy exposures.

ICON implemented a PRIM-based DPSS supported by early regulatory engagement and close collaboration with the sponsor's pharmacovigilance team.

Subject matter experts developed a Targeted Safety Questionnaire, which was reviewed by independent teratology specialists to ensure collection of clinically relevant maternal, foetal, neonatal, and infant outcome data. The program incorporated structured follow-up at predefined intervals, enabling intensive monitoring of reported pregnancies and comprehensive capture of pregnancy and infant outcomes.

Leveraging existing pharmacovigilance infrastructure, the model minimized operational burden and costs while enabling efficient study start-up, streamlined case identification and follow-up, and robust long-term pregnancy safety data collection.

The study received prompt FDA approval with only minimal protocol revisions required, enabling efficient study start-up and rapid implementation. The PRIM methodology supported consistent and intensive follow-up of reported pregnancies, facilitating robust collection of pregnancy and infant outcome data while optimizing operational efficiency in a low-exposure setting.