ATMP development in Europe lags behind other regions, potentially due to regulatory hurdles. This JOIN4ATMP subproject aims to build a comprehensive database to analyze these barriers and share successful strategies, ultimately guiding European ATMP developers on predictive preclinical testing for clinical safety and efficacy.
A broad survey comprising ~500 questions was developed for stakeholders such as 1. ATMP Developers 2. Insurance Payer 3. Regulators 4. Patients and their representatives 4. Legal advisors etc.
REDCap Clinical Trails software server deployed at Charite Berlin was used to present the survey. The questions were adapted to the REDCap software by including braching logic, validation and custom matrix fields. Finally, the suvery is made publicly available via a web-browser.