PROTECT WP5/WP6 Extension /Validation of Benefit-Risk Methods, - PowerPoint PPT Presentation

PROTECT – WP5/WP6 • Extension /Validation of Benefit-Risk Methods, Tools and Processes Evaluated in PROTECT- WP5 Presented by: Andrea Beyer, EMA

PROTECT- Work Package Overview • One WP concerned with all aspects of the organisation integration and representation and management of Work Package 5: Benefit/risk PROTECT Wpco-L: Imperial, ME • Four “vertical” WPs targeting the specific objectives and methodological developments • Two “horizontal” WPs concerned with the communication, validation and integration of the scientific work into an integrated and cohesive European activity 2

WP5- Benefit – Risk Methodologies 3

Tysabri: MCDA criteria contribution Stacked bar chart for Tysabri vs. all the other treatments. • Same information shown as a stacked bar chart. • Positive incremental benefit-risk components above the x-axis and negative ones below. • Total benefit-risk shown as the dark blue bar. 4

WP5/WP6 activities WP6 Workstream 2 Workstream 1 Validate visualisation tools Test how B/R methods adapt recommended by WP5 to the in a real-life setting targeted audience Lead Andrea Beyer (EMA) Lead Billy Amzal (LASER) 5

Patients/HCP/ Regulators Perception Measure dimensions of benefit and risk perception Visual presentation of Visual presentation of benefit and data risks using textual, tabular and other graphical formats Elicitation of Discrete Choice MCDA - preferences for treatment Experiment MACBETH outcomes 6

Data Collection – UK, France, the Netherlands Study Website Healthcare Regulators Patients Professionals General Assessors EMA/Scientific Pharmacists/ Practitioners/ CHMP/PRAC Administrators Nurses Specialists 7

Timeline/Deliverables 2013 Marc April May June July Aug Sept Oct Nov Dec h Testing Team Questionnaire design Questionnaire at LSE selection Refine Focus Final team Ethics research groups data assembled Review questions collection Programming of Translation of Translation of study website study website study website (English) (Dutch) (French) Patients and PCWP and HWP NHS Clinics HCWP discussions Recruitment 8

Participant Disposition Breast Cancer Atrial Patients 900 (300 per TA) Fibrillation Diabetes UK Breast Cancer Atrial HCP 900 (300 per TA) Fibrillation Diabetes 5400 Patients and Healthcare Professionals across 3 countries (plus Regulators) 9

Thank You for Your Support! 10 10