Abstract
BackgroundBiopharmaceutical companies are piloting patient experience surveys (PES) to help enhance patient satisfaction with clinical studies. However, most PES have been conducted at study close-out, which can hinder recall and responsiveness, and at a limited number of sites, which restricts their applicability to global studies. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience.MethodsTo develop sequential PES (introductory, interim, close-out), we customized a previously developed patient experience close-out survey. Extensive input was gained from multiple stakeholders (e.g., survey experts, patient advisors, psychometricians, clinical trialists, lawyers). To deploy the PES in global studies, we prepared PES-specific ethics committee submissions, training materials (e.g., slides, videos), and PES invitation aids (postcards, digital app reminders).ResultsDeveloping and deploying sequential PES in global clinical studies was feasible. The 3-part online PES (25 to 37 questions per survey) passed health literacy testing. To facilitate benchmarking, the PES included core questions (including a Net Promoter Score question). The PES gained ethics approval and was deployed globally in 2017–2018 in 12 phase 2 and 3 clinical studies in North America, Europe, and the Asia–Pacific. Based on the real-world insights gained and the challenges encountered, we have made recommendations for PES.ConclusionsOur practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies.
Highlights
Over the past 20 years, the increasing complexity of clinical studies has slowed the development of medicines [1, 2]
Feedback can be gained through patient experience surveys (PES), and early research has shown that PES can be implemented at the start or end of a study [18], or at both time points in a single-center setting [19]
Alignment with UCB Pharma best practice for protocol simplification meant that the PES were not included as a required activity within the clinical study schedule of events
Summary
Over the past 20 years, the increasing complexity of clinical studies has slowed the development of medicines [1, 2]. Innovative Medicines Initiative (Patients Active in Research and Dialogues for an Improved Generation of Medicines— PARADIGM) [12], and Patient Focused Medicines Development [16], among others, aim to build practical frameworks to guide patient engagement. Further real-world research is needed on PES [11], the use of sequential surveys within a study and within a global setting. Our aim was to investigate the feasibility of developing sequential PES, which would be deployed globally, and to provide practical recommendations based on our real-world experience. Conclusions Our practical recommendations on the development and deployment of sequential global PES may assist others to implement PES efficiently and effectively, allowing them to gain feedback from patients globally during clinical studies
Sign-in/Register to view highlights & summary Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
