Expanding the treatment space by access under systematic evidence-generation

Expanding the treatment space requires evidence generation to enable treatment decisions by key stakeholders. This task will establish standardised endpoints for data sharing. It will create a system for collecting and merging clinical outcome data from all patients discussed in molecular tumour boards In the end, this will allow data from clinical trials and official studies to be added and used together.

Increased access to targeted treatment requires identification of eligible patients for treatment both for standard of care treatment and experimental treatment. This work will involve creating guidelines for observing and recording patient data, as well as setting up ways to share that data. The goal is to generate strong evidence to support more personalised approaches to cancer treatment.

Implement strategies for expanding the treatment space of approved or soon-to-be-approved drugs. Collaborate with regulators and healthcare payers to develop frameworks (managed entry agreements) that support the collection of real-world evidence. This will enable drugs to be tested sooner and help bring them into routine healthcare.

Ensure that regulations are compatible with clinical trials, ensuring enough flexibility in Europe to address questions about personalised cancer medicine. Development of PCM implementation ecosystems; Creating an effective stakeholder ecosystem to coordinate an implementation approach that is fair and sustainable; Support the approval of practical, real-world clinical trials by helping to put new European regulations into action. Work closely with researchers running these trials to make the approval process faster and more efficient.