Author: Chi Pakarinen, Project Manager at The Synergist
Six co-creation Working Groups have been busy devising the various “How-To” modules, each focused on different activities and stages of the medicines development lifecycle. These are based on the Patient Engagement Quality Guidance and include:
- How-To-Module for the Early Discovery and Preclinical phases,
- How-To-Module A for the Clinical Trials phases,
- How-To-Module B for the Clinical Trials phases,
- How-To-Module for the Regulatory phase,
- How-to-Module for the Post-Marketing phase,
- How-To Module for the creation of Plain Language Summaries for scientific publications, and
- How-To Module for Capacity Building.
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!