Medicines are developed to improve the life of patients, which requires a deep understanding of their needs and priorities. These can be gained only through direct, sustained and constructive interaction with patients in all phases of the development of a medicine. PFMD embarked upon this project to co-create a systematic and consistent approach to patient engagement (PE), and aims to co-develop an efficient, measurable and reliable PE meta-framework that involves patients as partners. PFMD will also produce an implementation plan with a full toolkit to support all stakeholders who are just embarking on, or continuing their journey to engage with patients in a meaningful and sustained way that respects all parties involved and creates a true relationship.
1. The work started with a landscape analysis in 2016 that aimed at checking what kind of PE activities are being done and where stakeholders are in the PE landscape. We then did an analysis of existing PE frameworks (paper coming out) to see where are gaps and what will be needed to address them in order to drive and support a more systematic and meaningful patient engagement throughout the medicines development continuum by all relevant stakeholders.
2. We conducted a survey to find out what relevant stakeholders' expectations were in PE and of each other. This became the Stakeholders' Expectations Matrix, that was presented as a poster at ISPOR Europe in November 2017 (and also pending publication).
3. We gathered PE experts in 3 working groups (for pre-clinical, clinical phases, and post-approval) to identify the gaps, the fragmentation and to prioritise the needed actions to be taken in order to create a PE meta-framework that would be truly operational and useful for all stakeholders wanting to do patient engagement.
4. We have organised several workshops to co-create and test and validate a practical PE guidance (PE Quality Guidance) and also put it through public consultation to validate the need for, the content of and the usefulness of the content of this work. Please see more details in the initiative itself.
The outputs of the "PE Meta-Framework" will be hosted and integrated in SYNaPsE Mapping and Networking Tool and will include
- a Patient Engagement Quality Guidance,
- The Book of Good Practices,
- The Do's and Don'ts - practical tips to do patient engagment
- and other tools to support.
This project will co-produce a PE Meta-Framework (working name) which encompasses tools for meaningful patient an public engagement and involvement across the research and medicines lifecycle continuum, for all stakeholders. This toolkit will not duplicate the existing efforts, but will build on the existing knowledge, recommendations and guidances to form a strong and widely acceptable meta-framework that can be operationalised in organisations.
In addition to the toolkit, PFMD aims to build a support capacity that will provide help and guidance to stakeholders when they start piloting the PE practices/ tools provided in the meta-framework.
This work started in 2016 and is ongoing with expected outcome of a preliminary "strawman-framework" in late 2017 or early 2018.
Problems addressed by Initiative
The development of a medicine is a long and often complex process. Multiple experts and stakeholders contribute to important decisions along the development and lifecycle of a medicine. This project aims to bring all stakeholders together to co-create a framework and tools for a meaningful patient and public involvement and engagement throughout the research and medicines lifecycle, but also extending to the care journey. PFMD provides a neutral platform and forum for all stakeholders to share their best practices and collaborate in a pre-competitive environment to achieve the common and shared purpose and objectives for all stakeholders.
“Co-creation” is about encouraging fair and open participation and quality input based on experience and personal insights of all stakeholders (researchers, clinical developers, regulators, healthcare professionals and patients) to ensure we deliver significant and desired outcomes where the voice of each stakeholder is equally embedded in final outputs.