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.
Clinical study initiation readiness
Patient communication package - first review completed
Clinical study completion
Business and regulatory pathway defined
Project and research data management plan is in place. VALIDATE Trustworthy AI framework is developed.
The preparatory study initiation package is developed. Technical and user requirements are determined. The project enters into clinical model development phase.
Software development, testing, and integration. User interface prototype is designed. Technical requirement and specifications analysis is conducted. Integration and testing in clinical sites.
Clinical validation is kicked off with retrospective data from stroke patients along with validation in prospective clinical study.
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.
Development and application of dashboard for visualisation of usage data. Advocacy through communication and information.
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.