Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Glo
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ORIGINAL ARTICLE
Giving Voice to Clinical Study Participants: Development and Deployment of Sequential Patient Experience Surveys for Global Clinical Studies Elizabeth Manning1 · Mitch Herndon1 · Wendy Frye1 · Tammy S. Ice2 · Nadia Thyssen3 · Daphnee S. Pushparajah4 · Stephen L. Yates1 Received: 13 May 2019 / Accepted: 9 December 2019 © The Author(s) 2020
Abstract Background Biopharmaceutical 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. Methods To 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). Results Developing 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. 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. Keywords Patient-centric · Patient participation · Patient engagement · Social sciences · Attitudes surveys · Questionnaires
Introduction
Tammy S. Ice and Daphnee S. Pushparajah Employed by UCB Pharma at the time this research was undertaken. * Elizabeth Manning [email protected] 1
UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC 27617, USA
2
Accelerated Enrollment Solutions, Pharmaceutical Product Development, LLC, Wake Forest, NC, USA
3
UCB Pharma, Brussels, Belgium
4
Alexion Pharmaceuticals, Hayes, UK
Over the past 20 years, the increasing complexity of clinical studies has slowed the development of medicines [1, 2]. Complex clinical studies place a strain on all involved, including patient participants [1, 3, 4]. Not surprisingly, poor clinical study experiences can hinder recruitment and retention, which can then lead to study delays and increased costs [5–8].
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