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.
For Working Group 2 (WG), the focus is on Protocol Development in the phases of the clinical trial I, II and III
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.
A first draft list of activities was identified and presented at the Patient Open Forum held in Brussels in a working session with participants (representing Academia, Patients, Patient Organizations and Industry). These inputs have been consolidated during a physical workshop held in December 2019. The group is now focusing on a scoping exercise to identify existing tools that are close to the topics identified and subsequently producing a first draft content of the how-to-modules.