Imagine trying to prove a medicine works by only looking at a small, perfect group of people in a lab. This project finds ways to use actual patient records from the real world to fill in the gaps. It's like moving from a controlled studio photo to a real-life video to see how a product actually performs. This helps health authorities make faster, fairer decisions about which drugs to pay for.
Drug developers rely on expensive, rigid clinical trials that don't always reflect real-world patient outcomes. This leads to slower approvals and difficulties in getting drugs reimbursed by health authorities.
A pilot for extracting data from unstructured patient records and a screening tool to identify suitable registries for real-world evidence.
If you are a drug developer dealing with high costs and risks in clinical trials — this project developed tools to integrate real-world data that can de-risk decision making across all phases of drug development. This allows for more efficient trial designs and faster paths to market.
If you are a software provider dealing with messy, unstructured patient records — this project developed a pilot to extract minimal datasets from unstructured data. This enables the creation of tools that turn raw medical notes into valid evidence for regulators.
If you are an HTA body dealing with outdated evidence for drug reimbursement — this project developed a screening tool to identify suitable registries. This helps you make more patient-centered decisions based on how drugs perform in the real world.
Based on available project data, no pricing or implementation costs are provided.
The project aims to create an integrated platform and standardized methods to increase the usability of data across different registries, suggesting a goal for wide-scale adoption.
Based on available project data, specific IP or licensing agreements are not mentioned.
It develops an ethical and methodological system to help regulatory authorities and HTA bodies use real-world evidence for drug registration and assessment.
The project period is from 2023-01-01 to 2027-12-31.
The consortium is well-balanced for a translation project, consisting of 15 partners across 7 countries. With 8 universities and 1 research institute providing the scientific base, the project maintains a 20% industry ratio (3 industry partners, including 3 SMEs), ensuring that the tools developed for drug registries have a direct line to commercial and regulatory application.
Contact Academisch Ziekenhuis Groningen in the Netherlands
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