Continuous data collection via a federated sharing platform

Associated arm

Arm 2 - Personalised medicine

Associated work packages

WP 8 - Expanding the treatment space by access under systematic evidence-generation

Leading organisation

Co-leading organisation

Evaluators

This pilot will develop ways to securely collect and analyse real-world cancer data from multiple countries, in order to build larger patient cohorts and generate evidence that can inform decisions on cancer treatments and improve patient outcomes.

Pilot 8 will set up a system that allows different countries to share data on PCM while keeping it secure. This platform will combine clinical and molecular data in a consistent way, helping support regulatory decisions, clinical trials, managed entry agreements, and early access to new treatments across Europe.

The pilot includes two main use cases:

8.1 Expansion of Treatment Space and Cohort Design (Lead: UKSH (DE), (Co)Lead: RSD (DK), (Co)Lead: MSCI (PL): Build a network that analyses combined data from retrospective and prospective cohorts of patients defined by specific genetic and molecular characteristics. This will allow subgroup analyses and generate evidence that can help in decisions on drug approval and reimbursement.
8.2 Framework for Structured Access by Exploring the Potentials of Managed Entry Agreements (MEAs) (Lead: Unicancer (FR), (co)Lead: LUMC (NL): Will implement a framework for structured managed entry agreements to support negotiations between national or regional reimbursement agencies and the patent holder.

Overall, the pilot and use cases aim to explore innovative ways to improve access to cancer treatments by using continuous, real-world evidence generation.