PFMD: Book of Good Practices Methodology

Background

In 2016 PFMD started to bring together experts representing various stakeholders, with the objective of advancing the work needed for the co-creation of a coherent, scalable and actionable “meta-framework” for patient engagement (PE). The framework is aimed to be relevant and usable across all phases of medicines lifecycle, and support diverse stakeholders to implement more meaningful PE measures and practices.

The process started with landscape mapping, literature review and analysis of existing frameworks and toolkits, to learn from current efforts and avoid duplication of work. After the preliminary mapping exercise multi-stakeholder Working Groups (WGs) were established, a plan of action developed and specific Task forces convened to co-create an action plan to deliver the framework.

Co-creating a robust and coherent framework for PE requires collective effort and commitment. Therefore, more than 100 international experts joined forces, representing patients and patient organisations, industry (including clinical research organisations and biotech), independent experts (with backgrounds from academia, research and industry), Health Technology Assessment (HTA) and regulatory bodies.

To support practical implementation of the framework, another objective was to create a Book of Good Practices that would showcase initiatives with a good quality and level of PE that exemplify the 7 PE ​Quality Criteria p​ resented in the co-created ​PE Quality Guidance1 ​framework.

The creation of the Book of Good Practices was identified as a priority due to:

• ●  a lack of common agreement about what represents “good practice” in PE
• ●  a high demand and need to have access to examples demonstrating quality and impact of PEefforts
• ●  a need for examples offering practical guidance and providing a benchmark of “what goodlooks like” for newcomers to PE