Extended Validations of a Qualified Prediction System for Allograft Failure in Real-World Settings

Résumé fourni par la source

Purpose: The iBox prediction system for kidney allograft failure has been qualified by the European Medicines Agency as a surrogate endpoint for clinical trials, and recently received acceptance of Qualification Plan by the FDA. Although the iBox has been validated in multiple settings and cohorts, additional comprehensive validations are essential for the extension of its context of use in clinical trials as well as wider implementation in clinical practice.

Ce résumé expose les affirmations des auteurs. BNTIC ne l’interprète pas comme une validation indépendante des résultats.