By using the PE Quality Guidance that was co-created with patients and other stakeholders in the patient engagement (PE) and medicines landscape, our objective is to complement the existing guidance with concrete how-to guides that helps anyone wanting to start their PE journey. This is part of PFMD's larger objective to co-create a "PE meta-framework" that can be used by anyone who wants to start their PE journey or is looking for guidance on specific activities on how to involve patients.
Working Group 5 (WG) is not focusing on a specific phase in the medicines development continuum, but addresses specific activity that pans out across all phases. This is the co-creation of plain language summaries (PLS) for clinical trials and publications.
PROCESS & METHODOLOGY
PFMD called for interested individuals to join the co-creation WGs via snowball technique by communicating about the WGs in the PFMD membership and network in the summer and autumn of 2018. The open webinar for more information was held in December 2018 and final groups were formed in January 2019, with kick-off calls organised in February 2019.
The co-creation WGs will use the PFMD step-by-step approach together with the PE Quality Guidance in its work as well as integrate the usage of the 7 Quality Criteria in the final outcome. The process of co-creation will be the case in point for how to operationalise the guidance.
- WG5 has identified the need for high quality PLS that would bring value to lay patients and the work had partly started from a workshop co-led by PFMD and Envision Pharma in November 2018. This WG will continue the work to co-create a how-to module specifically to address this need.
- More steps in the way will be updated as the work progresses.
Link to the 150+ PE activities- initiative: https://tool.patientfocusedmedicine.org/initiatives/150-pe-activities-to-inform-pe-quality-guidances-how-to-modules)