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 resources
- 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.