Flamel was delighted to host the Inaugural PAG meeting April 2016. The genesis and evolution of the group can be traced back to the 2015 Narcolepsy Network annual conference. Patients and family members attending the conference were given and open invitation to join the group. A number of patients and parents of patients with narcolepsy volunteered. The group met for the first time April 9th 2016 for a full day meeting. The agenda included a range of topics which focused on providing critical background on clinical trial activities i.e. clinical trial design and set-up requirements, patient information needs, patient empowerment, and the FT218 clinical trial. Draft FT218 Clinical Trial patient facing materials and technologies were distributed to the group for review and commentary. The groups feedback let to a significant re-work of the Flamel generated patient materials and reconfiguration of the electronic technology app being used as part of the FT218 Clinical Trial. The outputs were significant and reinforced the absolute need and value of a patient-centric approach to clinical trial development activities. Flamel are now reassured that FT218 patient facing materials are aligned with the actual needs of patients.
Dr. Eveline Honig, Executive Director of the Narcolepsy Network who joined the meeting is most supportive of the initiative stating “much has been accomplished today, it is a important starting point, a very positive one, one which lays the foundations for a framework of clinical trial patient partnership which can perpetuate beyond the lifecycle of the Flamel Clinical Trial”
Since its establishment the PAG as gone from strength to strength. We are pleased to announce that a European PAG has now been established to provide European context.
Scheduled Meetings for Quarter 1 2018
- The 2nd PAG meeting for Europe will take place March 2018.
- The 5th PAG meeting for North America will take place April 2018.
Please watch this page for further updates on the REST-ON PAG framework.