Summary of Working Group/Task Force workshops and key outputs
| Date/location | Participants, N | Stakeholders represented* | Meeting objectives | Key outputs‡ |
| November 2016, Brussels | 24 | PA (n=5); industry (n=13); independent experts (n=3); CRO (n=1); HTA (n=2) | WG1: identification of critical success factors for involvement of patients in discovery and preclinical phases of medicines development† | Identified focus areas, priority projects and key actions for improving PE efforts. Agreed on resources required to undertake prioritised actions Individual WG members committed to specific tasks and actions |
| November 2016, Brussels | WG2: identification of critical success factors for involvement of patients in clinical phases of medicines development (phases I–III)† | |||
| February 2017, Brussels | 19 | PA (n=4); external experts (n=2); university hospital representative (n=1); regulatory/HTA (n=3); industry (n=9) | WG3: identification of critical success factors for involvement of patients in regulatory submission process and post-launch activities† | |
| May 2017, London | 16 | PA (n=4); academic/research (n=5); HTA (n=1); industry (n=6) | TF Europe: collection of PE initiatives in preclinical research and clinical phases of medicines development (phases I–III)† | Shared PE experiences in research and clinical development Developed basis of PE Quality Guidance guiding principles (Why, When, How, What) |
| June 2017, Basel | 12 | PA (n=5); industry (n=5); academic (n=1); global health organisation (n=1) | TF Europe: collection of PE initiatives in post-launch phase (including clinical development phase IV, adverse event reporting, and patient support activities) using the draft PE Quality Guidance tool | Application of PE Quality Guidance guiding principles to own postlaunch initiatives Identified gaps in PE Quality Guidance guiding principles and proposed solutions |
| June 2017, Chicago | 13 | PA (n=4); industry (n=6); hospital-based PE manager (n=2); external expert (n=1) | TF North America (USA and Canada: review, refinement and validation of the draft PE Quality Guidance tool by retrospective application of the tool to existing PE initiatives covering all phases beyond clinical development phase I | Application of draft PE Quality Guidance tool to own initiatives Identified gaps and co-created solutions to improve the practical use of the PE Quality Guidance tool based on their own experiences |
| October 2017, Brussels; February 2018, Brussels; June 2018, Brussels | 10 | PA (n=2); industry (n=3); academia (n=3); hospital-based PE manager (n=1); external expert (n=1) | Core Team: review and refine PE Quality Guidance tool; co-create Book of Good Practices; assess communications activity required | Finalisation of draft PE Quality Guidance tool Evaluation of PE initiatives for inclusion on Book of Good Practices Input into communications plans |
*Included participants with expertise in the relevant phases of medicines lifecycle.
†Phases of medicine life-cycle (The Drug Development Process. Available at: https://www.fda.gov/ForPatients/Approvals/Drugs/default.htm. (Accessed 21 June 2018); Lifecycle of a medicinal product - European Medicines Agency. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2015/01/WC500180644.pdf (Accessed June 21, 2018).
‡Outputs covered Step 1 (mapping and connecting the PE landscape to learn from existing efforts) and Step 2 (multistakeholder co-creation of PE guidance and good practice identification) of the approach for development of a pilot meta-framework for PE.
CRO, clinical research organisations; HTA, health technology assessment; PA, patient associations/organisations; TF, Task Force; WG, Working Group.