Integration of multiple oncology studies into a single OLE study

An oncology study involving 53 parent protocols - each with distinct timelines, sites, databases, and reporting requirements - needed to be integrated into a single open-label extension (OLE) study. The complexity was further heightened by the involvement of multiple stakeholders and CROs across the parent studies.

Because each parent study operated on different timelines, involved unique sites, databases, and reporting requirements, and was managed by various CROs and stakeholders, coordinating across these disparate elements required a unified strategy to ensure consistency and compliance. The need to accommodate a single asset in combination with multiple investigational medicinal products and regulatory pathways further increased the operational burden. Additionally, aligning communication and expectations across a broad stakeholder group while maintaining flexibility to incorporate new studies added to the challenge. Ensuring seamless patient rollover and regulatory continuity across global regions demanded a highly adaptive and centralized approach.

To manage the integration of the parent protocols into a single OLE study, ICON served as the central point of contact, overseeing all aspects of OLE development. Tailored communication strategies were implemented to align with the expectations of diverse stakeholders. ICON designed and built flexible IRT and EDC systems that could be easily adapted as new studies were added. The ICON Patient Navigator Tool, a customizable, scalable solution that tracks patients in parent studies and predicts rollover timing, streamlined regulatory submissions and site activations ensuring a seamless rollover for patients. The tool pulled real-time data from study trackers ensuring accurate projections and proactive risk management. 

ICON also leveraged prior country submissions, existing approvals, and overlapping sites to accelerate study setup. Additionally, a master IND was established, allowing subsequent protocols to be conducted under a unified regulatory framework, further simplifying governance and oversight.

The successful integration of 53 parent studies into a single OLE study significantly reduced the burden on sponsor resources and enabled the standardisation of processes for adding new protocols. This streamlined approach improved operational efficiency and long-term study management. As a result, the study has remained active and sustainable for over 10 years.