Imagine trying to find a key for a lock, but the keys are scattered across 19 different countries. This project creates a shared digital map so doctors can quickly find existing drugs that fit a patient's specific genetic mutation. It also builds a way to prove these drugs work without needing expensive, traditional trial groups by using digital records as a comparison.
Cancer drug access is fragmented across Europe due to varying diagnostic availability and inconsistent reimbursement rules for off-label use. This delays patient treatment and slows down the evidence generation process for pharmaceutical companies.
An automatic data-sharing platform for clinical trials and economic evaluation models for drug reimbursement.
If you are a drug developer dealing with fragmented clinical trial access across Europe — this project developed a single point of entry to access multiple trials. This streamlines how your drugs enter the market and reach patients with rare mutations.
If you are a diagnostics provider dealing with unequal availability of genomic testing — this project developed a system to align molecular diagnostics with treatment pathways. This increases the demand for your testing services across 19 countries.
If you are a payer dealing with uncertainties around the cost-effectiveness of off-label cancer drugs — this project developed economic evaluation models. These models provide budget impact analyses to make reimbursement decisions faster and more predictable.
The project develops economic evaluation models including budget impact and cost-effectiveness analyses to provide insights into affordability and timing of reimbursement for on and off-label drugs.
Based on available project data, the project aims to implement this across 19 European countries using an automatic data-sharing platform to accelerate evidence generation.
Based on available project data, the project focuses on a federated analysis and data-sharing platform, but specific licensing terms are not detailed.
The project assesses requirements for on and off-label reimbursement and addresses the lack of harmonized regulations for off-label use across participating countries.
The project period runs from 2023-07-01 to 2028-06-30.
The consortium is heavily weighted toward clinical and research expertise, with 20 research-focused entities (12 research, 8 university) and 5 other organizations. While the industry ratio is low at 11% (3 partners), the scale of 28 partners across 19 countries provides a massive network for cross-border data validation and market entry for pharmaceutical products.
Contact Oslo Universitetssykehus HF regarding the data-sharing platform
Contact us to identify pharmaceutical partners for the DRUP-like trials.
