Working groups

Co-creating a meta-framework for patient engagement takes collective collaboration and commitment. We’ve now held 5 workshops with 45 international participants representing patients/ patient organisations, industry (including CRO and biotech), independent experts (with backgrounds from academia, research and also industry), HTA and regulatory.


We started by establishing 3 Working Groups – each focuses on a specific phase of medicines development and lifecycle. Task forces have been created to take on agreed and prioritised actions including: Book of Good Practices task force (Discovery phase) Compliance & Legal Hurdles task force (clinical and regulatory phases), and the Good Patient Engagement Practices task force (post-launch phase.

Priority Actions Agreed

Creation of patient engagement guidance or “Book of Good Practices” across all medicines development phases with concrete examples of how to work with patients.

Lowering the compliance, legal and other administrative barriers to working with patients.

Identifying and including missing stakeholder groups to PFMD network and work streams.

Working groups

PFMD held the first two Working Group for the co-creation of the patient engagement (PE) meta-framework on 16 and 17th of  November 2016 at The Synergist offices in  Brussels. The meeting served to mobilise a dynamic community of stakeholders with diverse expertise, extensive networks and experience, and who are motivated to contribute to the PE journey. A common theme of the meeting was agreement on the need  to maintain momentum and secure participation from additional stakeholders.


Working Group Composition and participants

Working group 1

  • 3 patient / patient organisation representatives
  • 3 independent experts
  • 7 industry representatives

Working group 2

  • 4 patient / patient organisation representatives
  • 1 independent experts
  • 9 industry representatives (2 absent)
  • 2 regulatory / HTA representatives


Working group 1

Working group 2


Final outcomes

Overlapping themes surfaced and were discussed during both workshops. These were:

  • A strong need for a  guidance document/ “book of good practices” to clarify HOW, WHEN and WHY to involve and engage with patients;
  • A need to create and enforce a structured/ systematic feedback loop in all phases of medicines development;
  • A need to clarify roles/responsibilities of patients and other stakeholders in PE, and to align stakeholders’ objectives;
  • A need to create a platform/ hub where researchers can connect with patients or patient organisations;
  • A need to include regulators, HTA , academia more strongly in all phases of medicines development cycle;
  • A need to build the capabilities, knowledge and training for all stakeholders based on existing material and experiences.

PFMD Working Group 3 (WG), focusing on Phase IV clinical studies and life-cycle management including safety and compliance, was held on February 16th, 2017 with 19 stakeholders representing patient organisations, regulatory bodies, the HTA sector, as well as the pharma and life sciences industry. Similar to the previous working groups, this meeting served as a kick-off to mobilise and identify key gaps and opportunities in patient engagement, in the focus area. The outcomes of the day are a set of prioritised action points that will be worked on in separate task forces.


WG3 participants

  • 4 patient / patient organisation representatives
  • 2 independent experts
  • 1 university hospital representative
  • 3 regulatory / HTA representatives
  • 9 industry representatives


Main takeaway points

  1. Including more representative stakeholders in PFMD: HCPs [e.g. prescribers, specialists involved in clinical trials] and Payers
  2. Good Patient Engagement Practice – developing mandatory guidelines for patient engagement (with incentive for regulatory agencies and payers to increase patient engagement
  3. Patient input quality:
    1. Provide clear, generally accepted scientific guidelines and standards for representative patient input, and clear legal standards for patient engagement  that are generally accepted across stakeholders.
    2. 1) Define criteria for patient input quality, 2) find best practices, and 3) create a “how-to” manual
  4. Develop a broadly endorsed framework for securing support for patient adherence (a holistic framework beyond a product/ company)
    1. Analyse existing compliance data and feedback into patient engagement  framework.

Working Process

All three working groups followed the same process during the day:


Participants were divided into subgroups with the task to identify gaps, opportunities, tools and methods in PE from the existing frameworks. They also identified stakeholders who were needed in the co-creation process, but who were not currently involved.


Subgroups then conducted a prioritisation exercise to first create action items out of identified gaps and opportunities, and then identify and prioritise three action items. Prioritised action items from all three subgroups were shared and overlapping items were merged.


These were further assessed by all participants to identify immediate priorities.

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