An established customer sought to streamline patient follow-up across multiple clinical protocols, each involving different sponsors and assets. The solution needed to support ongoing treatment and safety data collection, while incorporating a ‘future-proof’ design capable of integrating future parent protocols across diverse assets, populations, and geographies.

The execution of a unified follow-up framework for patients enrolled in multiple clinical protocols presented several challenges:

Protocol complexity and variability: Each clinical protocol involved different sponsors, assets, and operational requirements, making it difficult to harmonize follow-up procedures and data collection standards.

Data integration and safety monitoring: Ensuring consistent and compliant safety data collection across disparate systems and treatment pathways required robust infrastructure and coordination.

Scalability and flexibility: Designing a ‘future-proof’ model that could accommodate new parent protocols - spanning various therapeutic areas, populations, and geographies -demanded a highly adaptable and modular approach.

Operational uncertainty: While the customer was committed to the concept, they lacked a clear roadmap for implementation, including governance, resource allocation, and cross-sponsor collaboration.

Regulatory considerations: Navigating regulatory requirements across regions and ensuring ethical continuity for patients transitioning between protocols added layers of complexity to the design. 

To address the complexity of managing multiple clinical protocols, a platform protocol design was implemented to support various assets and indications. Flexibility was enhanced by submitting protocol appendices under separate EU-CTR numbers, allowing for modular updates and streamlined approvals. A centralized safety database was established for safety data collection, eliminating the need for traditional eCRFs. Regulatory requirements were met by aligning with EU expectations for clinical study reports (CSRs), while also accommodating FDA guidelines, which do not require CSRs for studies under intermediate INDs. Future parent studies involving new assets can be seamlessly integrated through the addition of new appendices, submitted alongside the master platform protocol to maintain consistency and scalability across geographies and therapeutic areas.

The operational and data collection approach eliminated the need for a Case Report Form, significantly reducing site burden while maintaining simplicity and ensuring data integrity. This model also supported the efficient addition of future parent protocols by securing approvals prior to First Patient In, regardless of location. In countries where the platform protocol had already been approved for an asset, no additional approvals were required, which substantially lowered study costs. Aligning all parent protocols under a single platform managed by one team - utilizing unified systems such as eTMF and CTMS, along with common plans and reports -streamlined processes, reduced effort and associated costs, and enhanced overall efficiency.