Transitioning from a Phase 3 study to an EAP

This case study highlights the strategic execution of an Expanded Access Program (EAP) across multiple global regions, Europe, Asia-Pacific, and Latin America, following a Phase 3 clinical study. The client faced significant delays in closing the Phase 3 study due to challenges in initiating the EAP, compounded by communication gaps and lack of knowledge by the investigators.

The primary challenge stemmed from the client’s attempt to initiate the EAP independently, which led to delays in the closure of the Phase 3 study. These delays not only impacted timelines but also raised concerns about ongoing study costs and regulatory compliance across regions. 

To overcome these challenges, ICON implemented a revised operational approach to the EAP model - realigning regulatory requirements for clarity, strengthening communication to close existing gaps, and updating country specific start-up timelines to address corporate concerns around ongoing Phase 3 study costs. 

To mitigate packaging delays, open-label supply already available on-site was utilized. ICON also leveraged existing site documents from the Phase 3 study to streamline the EAP setup. Site hesitation was addressed through enhanced training and consistent communication, ensuring confidence in the new program design. Internal cross-functional communication with ICON’s Phase 3 and EAP teams and the client further supported smooth execution across regions. 

The revised strategy led to a seamless transition with zero missed doses for patients converting to the EAP. The first country in the EU was activated just nine weeks after the award, and 100% of patients were transitioned within 14 weeks. Site hesitation and operational challenges were effectively eliminated. Most notably, the sponsor achieved a database lock for the pivotal Phase 3 study ahead of corporate goals, marking a successful and efficient program closeout.