Author: Chi Pakarinen, Project Manager at The Synergist
The co-creation Working Groups have been busy devising the various “How-To” guides, each focused on different activities and stages of the medicines development lifecycle. Check them out here. These are based on the Patient Engagement Quality Guidance and include:
- How-To Guide for Patient Engagement in the Early Discovery and Preclinical phases
- How-To Guide for Patient Engagement in the Clinical Outcome Assessment development
- How-To Guide for Protocol Design
- How-To Guide on Plain language summaries (PLS) of peer-reviewed publications and conference presentations: practical ‘How-To’ Guide for multi-stakeholder co-creation
Almost all groups are in drafting mode, with public consultations opening up soon to gather feedback from the PFMD network and wider community, giving everyone the opportunity to contribute. The drafts for the How-To Modules covering the early phases will be finalised in the next couple of weeks and will then enter the review and validation rounds. Kudos to the contributors in How-To-Module for the Early Discovery and Preclinical phases.
Meanwhile, the How-To’s for Clinical outcomes assessment and Plain language summaries for scientific publications are following suit, with draft contents to be finalised by the end of May/ early June. Much luck and energy for the final push for How-To-Module A for the Clinical Trials phases, and How-To Module for the creation of Plain Language Summaries for scientific publications!
The creation of the patient engagement education and training repository is well underway with a preliminary list almost finalised. This will be merged with the Patient Engagement Training to establish a catalogue that will help all stakeholders in capacity building. Great job team How-To Module for Capacity Building!
The team continues to explore the content and progress of other groups who are working on patient engagement in protocol design, in the regulatory submission phase and in the post-launch phase. The outcomes of their work will add tremendous value to the community and we wish them continued momentum to also deliver the final steps in their How-To’s during the next few months!