TRAINING MATERIALS

• PROTECT Final Symposium Training, 18th February 2015

  PROTECT Final Symposium Training, 18th February 2015

  These training materials were presented at the PROTECT Final Symposium that took place in February 2015 at the European Medicines Agency. The objectives are to introduce (1) the main concepts of benefit-risk assessment, (2) a range of methodologies used in connection with benefit-risk assessment, (3) key methodologies via worked examples, (4) a range of visual representations to accompany benefit-risk assessment, (5) a selection of visual displays via worked examples, and (6) the role of patient and public involvement in benefit-risk assessment.

  Presentation slides

  • Ashby, D. Introduction to benefit-risk assessment of medicinal products.

  • Nixon, R. Structured benefit-risk assessment.

  • Mt-Isa, S. Taxonomy of benefit-risk assessment methodologies; and BR metrics.

  • Phillips, LD. Benefit-risk assessment: Concepts and methods.

  • Postmus, D. Open source software for benefit-risk modelling and clinical data analysis: ADDIS and Effects Table

  • Hallgreen, C. Visualising benefits and risks: concepts and ideas.

  • Downey, G. and Das, S PROTECT resources for further learning.

  • Waddingham, E. Patients and public involvement in benefit-risk assessment and decision-making: methods and applications.

  • Beyer, A. Eliciting Patient Preferences: Applying decision theory to health research.

  Video recordings

• MCDA Hiview 3 Guidance

  MCDA Hiview 3 Guidance

  • Phillips, LD. Modelling the benefit-risk of medicinal products using Hiview 3.