1. CIOMS Working Group XI – Patient Involvement
Definition (Harrington R., et al. Defining Patient Engagement in Research: Results of a Systematic Review and Analysis. (ISPOR’s Patient-Centered Special Interest Group) - forthcoming publication (do not share beyond WG)
Meaningful patient involvement
Active and collaborative interaction between patients and other key stakeholders, where decision-making is guided by patients’ values and contributions, across all stages of development and use of medicines. Patients should be considered as partners whose unique experiences and expertise is recognized and valued.
 Meaningful patient involvement
Recognizing patients' unique experiences and expertise decision making across all stages of development and use of medicines is done in active partnership between patients and other key stakeholders
Notes*:
Patient involvement should follow the principles of partnership, transparency, inclusiveness and diversity.
Patient-centered information sources and outcomes that matter to patients are the priority.
Reference to patients can also include parents, informal carers and patient organisation representatives.
*National Health Council. The Patient Voice in Value: The National Health Council Patient-centered Value Model Rubric (March 2016) Available from:
(Comment from Stephen: This section overlaps with section 5.c below)