Delivering pregnancy exposure evidence through a hybrid global model

Global pregnancy safety programs require flexible evidence-generation strategies that can adapt to regional regulatory requirements, operational constraints, and differences in expected pregnancy exposures across markets. ICON designed and implemented a hybrid pregnancy safety study combining a decentralised US pregnancy registry with a Pregnancy Outcome Intensive Monitoring (PRIM) approach across the rest of the world.

The US pregnancy registry leveraged direct-to-patient and healthcare provider (HCP) data collection to prospectively capture pregnancy exposures and outcomes, while PRIM utilized pregnancy exposure reports collected through enhanced pharmacovigilance processes and complemented them with structured follow-up to capture maternal, foetal, neonatal, and infant outcomes. Together, these complementary approaches enabled efficient real-world evidence generation and provided comprehensive, scalable, and sustainable global pregnancy safety monitoring.

The sponsor required worldwide pregnancy safety surveillance aligned with FDA, EMA and global pharmacovigilance expectations. Regional differences in regulatory requirements, patient access, and expected pregnancy exposure rates across markets meant that a single, uniform approach was not practical. In particular, varying levels of anticipated pregnancy exposures and restricted access to patients in certain geographies, required a flexible, region-specific strategy while maintaining global consistency in scientific oversight, data collection, and governance. 

ICON designed a hybrid model combining a decentralised US observational pregnancy registry with a PRIM-based approach across the rest of the world.

The US registry leveraged direct-to-patient and healthcare provider recruitment and data collection to prospectively capture pregnancy exposures and outcomes. Recruitment and case identification were further supported through the product's Risk Evaluation and Mitigation Strategy (REMS) program and its Elements to Assure Safe Use (ETASU), providing access to certified prescribers and facilitating awareness, patient referral, and pregnancy case capture.

Outside the US, the PRIM methodology enabled structured collection and follow-up of pregnancy cases reported through enhanced pharmacovigilance processes.

To ensure consistency across all geographies, ICON implemented harmonised data collection standards supported by dedicated scientific and operational governance. Centralized oversight ensured study continuity, quality assurance, regulatory compliance, and consistent assessment of pregnancy outcomes across regions.

This integrated framework enabled comprehensive global pregnancy safety monitoring while accommodating regional differences in patient access, regulatory requirements, and expected pregnancy exposure rates.

The hybrid approach delivered a scalable and sustainable global pregnancy safety monitoring framework while reducing operational complexity. By combining a decentralised US pregnancy registry with a PRIM-based approach in the rest of the world, the program achieved broad geographic coverage, maximised pregnancy case capture, and supported consistent long-term collection of pregnancy and infant outcome data within a single integrated framework.