Validation of a Trustworthy
AI-based Prognostic Tool for
Predicting Patient Outcome
in Acute Stroke

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About the project

Based on pre-clinical evidence and previously developed models, and an available prototype of a clinical decision support system (patent pending), we set out in this project to further develop, test, and validate a prognostic tool for outcome prediction of acute stroke patients.

Beneficiaries
0
Pilot Sites
0
Budget
0 Million €
artificial intelligence

Milestone 1

Clinical study initiation readiness

Patient Communication Package Review

Milestone 2

Patient communication package - first review completed

Study Completion

Milestone 3

Clinical study completion

pathway

Milestone 4

Business and regulatory pathway defined

Project timeline

May 2022
Project month 1
Project start

Project and research data management plan is in place. VALIDATE Trustworthy AI framework is developed. 

January 2023
Project month 8
Study initiation package

The preparatory study initiation package is developed. Technical and user requirements are determined. The project enters into clinical model development phase. 

September 2023
Project month 16
Software development and integration

Software development, testing, and integration. User interface prototype is designed. Technical requirement and specifications analysis is conducted. Integration and testing in clinical sites. 

May 2024
Project month 24
Clinical validation

Clinical validation is kicked off with retrospective data from stroke patients along with validation in prospective clinical study. 

January 2025
Project month 32
Uptake and regulatory acceptability

Strategy is designed for uptake in national and EU clinics entailing budget-impact models for hospitals, health systems, and payers. Regulatory acceptability and medical device certification is obtained. 

September 2025
Project month 40
Application and use of data

Development and application of dashboard for visualisation of usage data. Advocacy through communication and information.

May 2026
Project month 48
Project end

Project objective achieved. The results of our work will serve as a pathway for future projects and we will make our experiences public in the form of standard operating procedures (SOPs) in the areas of development, testing, validation, and regulatory processes. 

Latest News

VALIDATE at Brain Awareness Week

We marked our presence in the  #BrainAwarenessWeek, 11-17 March 2024, through one of our partners, Stroke Alliance For Europe (SAFE), by presenting VALIDATE with the voice […]
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Business delegation Get-together

We are delighted to share an update from our project! Recently, during engaging discussion among a business delegation of healthcare professionals and care-provider executives […]
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