Table 1

Summary of Working Group/Task Force workshops and key outputs

Date/locationParticipants, NStakeholders represented*Meeting objectivesKey outputs‡
November 2016,
Brussels
24PA (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, BrusselsWG2: identification of critical success factors for involvement of patients in clinical phases of medicines development (phases I–III)†
February 2017, Brussels19PA (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, London16PA (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
12PA (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 toolApplication of PE Quality Guidance guiding principles to own postlaunch initiatives
Identified gaps in PE Quality Guidance guiding principles and proposed solutions
June 2017, Chicago13PA (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 IApplication 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
10PA (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 requiredFinalisation 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.