Join Cytel for a new 2-part webinar series discussing US Food and Drug Administration (FDA) and European Medicines Agency (EMA) are encouraging sponsors to collect patient experience data as part of development programs, including evidence on patient preferences. The FDA has released guidance for patient-focused drug development and for the use of patient preferences in evaluating treatment benefits and risks. The EMA has qualified patient preference methodologies for regulatory purposes. In addition, selected Health Technology Assessment (HTA) bodies as well as payers are interested in identifying the patient-relevant benefit of innovative drugs.
Some clinical development programs do not account for the patient perspective early enough, leading to clinical trial designs with endpoints that are not patient relevant. Early patient preference data allows sponsors to select endpoints that matter to patients, and to evaluate a benefit-risk profile from the patient perspective. Early research on the patient perspective also supports later market access activities/HTAs, by defending innovative trial endpoints and by presenting benefit-risk assessments from the patients.
In the second webinar of the series Thomas and Tommi will cover case studies and practical guidance to help design an impactful patient preference study. The webinar will cover how to IMI PREFER method classification and key preference methods, as well as practical considerations for selecting the appropriate method.
Next Tommi covers case studies focusing on:
- Patient preferences for patient-reported outcome (PRO) label claim
- Benefit-risk assessment and dose selection
- Value communication
- Preferences in diverse patient groups
- Dr Thomas Wilke, Contract Principle, RWA, Cytel
- Dr Tommi Tervonen, Chief Scientist, Kielo Research
