PURPOSE:

• Review good methods practices in co-creation with patient partners, particularly when developing a clinical outcome assessment (COA)-strategy as part of patient-focussed medical product development (PFMD);
• Review barriers to meaningful and successful co-creation partnerships with patients and possible solutions to overcome those barriers;
• Provide an interactive experience through case-example discussion with online polling; and
• Influence and improve future good practices in COA-strategy development through patient engagement and co-creation partnerships.

DESCRIPTION:

Globally, stakeholders recognise the need for early integration of patient engagement (PE) and active co-creation to achieve the outcomes that matter most to patients to ensure PFMD. COAs, measures describing how a patient feels, functions or survives, are a key component of PFMD. For development to be patient centered, the COA-strategy (i.e., COA identification, implementation, interpretation and communication) should include patients as partners. This workshop will begin by introducing and reviewing disease-agnostic existing co-creation guidance, methods and good practices to produce a COA-strategy co-created with patients.

Speakers will then present 2 case examples of patients as partners in COA-strategy development, from a patient expert and regulatory standpoint, respectively. A critical evaluation of each example will be discussed, including:

1. Assessment of whether or not good PE and co-creation methods practices were used;
2. Identifying barriers encountered to meaningful PE and solutions leveraged, and
3. How patient co-creation influenced the strategy.

The audience will participate in the exercise through discussion and real-time online polling. Speakers are experts in PE and COAs from the patient, industry, and regulatory community.