Consolidation of multiple protocols into a single LTE oncology study

To ensure continuity of care for participants in the maintenance phase of multiple parent studies in oncology managed by ICON and third-party vendors, a consolidated long-term extension (LTE) protocol was required. It encompassed seven parent studies across two assets, with flexibility to incorporate future studies and additional assets. The goal was to initiate the extension rapidly to optimise operational and financial efficiencies while maintaining uninterrupted treatment for participants.

• Implementing a consolidated LTE protocol posed several operational and strategic challenges: Cross-vendor coordination: Harmonizing processes across multiple CROs required alignment on timelines, data standards, and governance, which introduced complexity and potential delays.
• Protocol integration: Designing a flexible LTE protocol that could accommodate diverse study designs, assets, and future additions demanded a modular and scalable framework.
• Regulatory navigation: Managing submissions under varying regulatory pathways (e.g., EU-CTR, FDA IND) required careful planning to ensure compliance while maintaining agility for future protocol expansions.
• Operational urgency: The need to deploy the LTE rapidly to avoid treatment gaps and maximize efficiencies placed pressure on planning, approvals, and resource mobilization.
• Data continuity and safety monitoring: Ensuring seamless safety data collection and continuity of treatment across studies with differing data capture methods and systems added further complexity

To support continuity of care and streamline operations across multiple parent studies, a consolidated LTE protocol was developed with flexibility and scalability at its core. The protocol was designed to accommodate any qualifying parent study from the outset, enabling the inclusion of multiple assets and indications without delay. Patient status across all parent studies—regardless of the managing CRO—was tracked using ICON’s Patient Navigator tool, a customizable, scalable solution that tracks patients in parent studies and predicts rollover timing. The tool pulled real-time data from study trackers for accurate projections and proactive risk management ensuring centralized oversight and seamless transitions. Safety data was collected through a dedicated safety database, eliminating the need for traditional eCRFs and simplifying data management across studies.

The consolidated LTE protocol significantly reduced operational costs, lowering the estimated monthly expense 55% when managed separately across seven parent studies. This streamlined approach not only improved financial efficiency but also positioned the framework to accommodate multiple additional parent studies and assets in the future, ensuring scalability and sustained continuity of treatment.