List Item Letter Of Support For A Model-based Clinical Trial Simulation Platform To Optimize Design Of Efficacy Evaluation Studi.pdf

letter-support-model-based-clinical-trial-simulation-platform-optimize-design-efficacy-evaluation_en.pdf
Preview of List item Letter of support for a Model-based Clinical Trial Simulation Platform to Optimize Design of Efficacy Evaluation Studi
🔗 Source: ema.europa.eu
📊 Size: 187 KB
👤 Author: Visco Angela
⬇️ Downloads: 59

Summary

The European Medicines Agency (EMA) provides a letter of support for a model-based clinical trial simulation platform to optimize the design of efficacy evaluation studies in Parkinson's disease. The platform, developed by the Critical Path for Parkinson's (CPP) Consortium, aims to improve research and development decision-making using model-informed drug discovery and development (MID3). The platform uses data from various studies, including the ADAGIO, CamPaIGN, and PPMI studies, to simulate clinical trials and inform trial design, inclusion/exclusion criteria, and endpoint selection. The EMA supports the use of this platform to optimize clinical trials assessing MDS-UPDRS Part II or III progression, with the goal of facilitating regulatory endorsement of optimal study characteristics.

Description

The European Medicines Agency (EMA) provides a letter of support for a model-based clinical trial simulation platform to optimize the design of efficacy...

Technical Information

  • File Format: PDF
  • File Size: 187 KB
  • Pages: 4
  • Language: EN
  • Author: Visco Angela
  • Total Downloads: 59
  • Last Updated: 4 hours ago

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