Patient-centricity continues to be a buzz-word in the clinical research landscape and one proposed remedy to the inefficiencies and complexities of the trial process. However, integrating patient engagement methodologies throughout the drug development process – from clinical studies through post-approval programs – remains a challenge for many companies due to a variety of reasons, including (but not limited to):
- lack of executive support
- siloed departments and goals
- finite resource
- limited understanding of how to effectively integrate the patient perspective
In addition, regulators and payers are requiring increasingly nuanced patient involvement for approval and market access, as seen in guidance documents like the PDUFA V, the 21st Century Cures Act Title III (Section 3002), EMA Annex II, EUPATI guidance documents, etc.
Collaborative efforts and shared learnings on patient-centric methodologies among stakeholders will help drive noticeable progress in our collective efforts of achieving patient-focused drug development. From patient input into clinical protocol design, to defining patient outcomes through clinical assessments, to capturing and including patient preferences, patient insights are no longer a "nice to have" but are now a necessity in your product's development plan.
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Discussion Points
- Highlight innovative techniques for capturing patient insights
- Provide a framework for some best practices for engaging patients
- Discuss latest perspectives on patient-centricity
- Discuss how to engage patients through advocacy partnerships
- Discuss best practices for developing patient-facing communications
- Discuss case studies to support implementation
Key Learning Objectives
- Understand the changing dynamics and new paradigms in patient-centricity
- Gain insight into innovative patient engagement methodologies
- Learn some best practices of patient engagement based on real-life experiences
Featured Presenters
- Erem Latif, MSc, MBA, Director, Patient Engagement, Patient-Centered Research, Evidera
- Deborah Collyar, President, Patient Advocates in Research
- Catina O'Leary, PhD, LMSW, President and CEO, Health Literacy Media