Track 5: Patient Engagement
This track, composed of 12 sessions, is themed, Operationalizing Patient Engagement, and Concepts of Meaningful Patient Engagement. It will address meaningful patient engagement in medical product development, from early product development, and approval, through maintenance phases. It focuses on important questions for all stakeholders, including:
- How do we meaningfully engage patients and incorporate their voices into decision-making throughout the medical product life cycle?
- How do we become truly patient- (and people-) centric in our approach?
- How do we operationalize patient-centric approaches in our day-to-day work?
- How can we measure the effectiveness of our efforts, both for patient outcomes and to meet the needs of other stakeholders such as industry and regulatory decision-makers?
- What have we learned that can be used to drive more meaningful patient engagement?
- How do stakeholders best work together to leverage their collective power and expertise to promote meaningful involvement of patients?
Included Topic Areas in Patient Engagement
DIA 2018’s Program and full list of sessions will be available in January. Meanwhile, see what topics and priorities we are designing content for.
- Outcomes of collaboration between industry, patient advocacy groups, and regulators during research and development phases of product development
- Operationalizing the outcomes of patient-focused drug development meetings
- Patient initiatives at FDA
- Lessons learned from existing interactions
- FDA Patient Representative Program
- Engaging with diverse patient populations
- PE metrics, outcomes, tools, and resources
- FDA plans for new initiatives
- Beyond the need for multi-stakeholder engagement: so what does it look like?
- Success stories and lessons learned in implementing partnerships to advance awareness and education about and participation in research among communities that are disproportionately impacted, under-represented, and under-served
- Understanding the patient experience using web-based registries and platforms
- Different roles of patient advocacy groups in collecting patient-reported data
- Utility of data, including impact on development of endpoints and measurement of symptoms
- Unique challenges faced by rare diseases
- Evolution of patient advocacy groups: a new type of peer and partner
Who is This Track Designed For?
Professionals involved in: patient affairs, patient advocacy, patient groups, patient support services, medical affairs (including CMOs and MSLs), clinical trial design and optimization, clinical research and operations, regulatory affairs, regulatory agency, corporate and government affairs, safety and pharmacovigilance, outcomes research, epidemiology, and Health Technology Assessment..