Table 3 Original list of 23 patient engagement impact measures
Medicines R&D priorities | Clinical trial design | Regulatory/market access submission | Product support and information | Disease support and information |
|---|---|---|---|---|
Number of changes made to the research or development plan | Number of changes to reduce the burden of study for patient participants | Patient insights included in development programme to inform submissions | Patient understanding of their medicine | Improved engagement with their disease and/or ability to self-manage |
Development of clinical outcomes/clinical measures | Earlier regulatory submission, approval and/or market access submission | Patients’ critique of evidence generated from clinical trials included in submission | Patient adherence with medicine | Patient adherence with medicine |
Development of Patient Reported Outcomes/Experiences | Number of changes made to the final version of patient-facing documents | Achieving regulatory approval/market access recommendation consistent with patient population studied | Clinical outcome or clinical measure improvements | Clinical outcome or clinical measure improvements |
Development of tolerability/side effect profile | Number of patients complying with study protocol | Achieving regulatory approval/market access recommendation with more informed label | Patient opinions on risk/benefit | Reduction in utilisation of healthcare resources |
Patient testimonials/feedback* | Study participants’ experience & satisfaction ratings | Reduction in utilisation of healthcare resources |