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List Item Qualification Opinion - C-PATH Response To IBox Scoring System (Composite Biomarker Panel) - List Of Issues (PDF/1.25.pdf

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Preview of List item Qualification opinion - C-PATH response to iBox Scoring System (Composite Biomarker Panel) - List of Issues (PDF/1.25
🔗 Source: ema.europa.eu
📊 Size: 1.25 MB
📄 Pages: 14 pages
⬇️ Downloads: 115

Summary

The European Medicines Agency (EMA) is evaluating the iBox Scoring System, a composite biomarker panel, as a surrogate endpoint for efficacy in clinical trials of novel immunosuppressive therapies (ISTs) in kidney transplant recipients. The system aims to predict the five-year risk of death-censored allograft loss and is intended for use in clinical trials to support evaluation of novel IST applications via conditional marketing authorization (CMA). The EMA acknowledges the strengths of the model development and validation approach but notes that further analysis is needed to establish the properties of the iBox scores as a surrogate endpoint and to determine the clinical meaningfulness of differences in transplant recipient survival with new therapy.

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Description

The European Medicines Agency (EMA) is evaluating the iBox Scoring System, a composite biomarker panel, as a surrogate endpoint for efficacy in clinical trials...

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  • File Format: PDF
  • File Size: 1.25 MB
  • Pages: 14
  • Language: EN
  • Total Downloads: 115
  • Last Updated: 1 week ago

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