Final study protocols for demonstration projects submitted to EU PAS register

Task 15 Execute five demonstration projects for established and newly marketed products to tackle methodologicaldata source issues where progress and innovation is needed M12M54 UOSLO JAN Lilly ULST SGUL CHUT THL USWAN UMCG CNRIFC FISABIO FERR INSERM UMAN EMA and Third Parties institutions providing data data expertise and clinical expertise Sanofi NVS Pfizer GSK Merck in collaboration with WP7See also table task 15 Part BThe demonstration projects have been chosen according to the following criteria high public health importance address known knowledge gaps together of sufficient variety including established vs new medications chronic vs acute condition rare vs common condition to innovate in their use of methodological approaches and new data sources Data sources will be selected according to a combination of costeffectiveness in terms of size of population and cost and data quality but in addition priority will be given to use of new data sourcesThe five demonstration projects will each integrate multiple aspects for each therapeutic area ie medication use in pregnancy and in women of childbearing age the impact of maternal disease on maternal perinatal and childhood outcomes and the impact of medications medication classes during pregnancy on outcomes While one therapeutic area will take the lead for each methodological innovation methods will be shared between demonstration projects Each demonstration project follows a general process of subsequent steps Step1 data characterisation M012 WP7 Step 2 protocol writing for each project and approval M1216 Step 3 obtaining data access WP7 Step 4 Data validation and assessing variation in prevalence of adverse outcomes see Task 13 with the addition of validation of exposure and confounder data M1236 Step 5 Statistical analyses starting with detailed Statistical Analysis Plans M1648 and Step 6 Study report or manuscript M4854 WP1 and WP7 will collaborate in the implementation of these demonstration projects according to a detailed process map Appendix after Section 5 to align and optimise the various tasksThe WP1 demonstration project teams will be made up of partners and third parties with substantive methodological and data source expertise and will appoint clinical advisors to advise on treatment practice in Europe Partners will be given the lead on various crosscutting methodological areas eg other than the demo project methodological leads already mentioned UMCG will take the lead for medication utilisation protocols USWAN will take the lead for integration of breastfeeding data when assessing confounding for long term outcomes CNRIFC will take the lead for validating nonprescription exposure data by linkage to prescriptions A joint statistical method working group will be set up including representation of SGUL GSK JAN Pfizer and WP7 UMCU ARS The demonstration projects will follow the ENCEPP Code of Conduct for Scientific Independence and Transparency A list of possible conflicts of interest for PP and EFPIA will be agreed before study teams for demonstration projects are finalised