UCB Pharma, 8010 Arco Corporate Drive, Raleigh, NC, 27617, USA.
Accelerated Enrollment Solutions, Pharmaceutical Product Development, LLC, Wake Forest, NC, USA.
Ther Innov Regul Sci. 2020 Sep;54(5):1001-1009. doi: 10.1007/s43441-020-00115-5. Epub 2020 Jan 21.
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.
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).
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.
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.
生物制药公司正在试行患者体验调查（PES），以帮助提高患者对临床研究的满意度。然而，大多数 PES 都是在研究结束时进行的，这可能会阻碍回忆和响应能力，而且只在有限的几个地点进行，这限制了它们在全球研究中的适用性。我们的目的是调查开发顺序 PES 的可行性，这种 PES 将在全球范围内部署，并根据我们的实际经验提供实用建议。
为了开发顺序 PES（介绍性、中期、结束），我们定制了以前开发的患者体验结束调查。从多个利益相关者（例如，调查专家、患者顾问、心理测量学家、临床试验人员、律师）获得了广泛的投入。为了在全球研究中部署 PES，我们准备了特定于 PES 的伦理委员会提交材料、培训材料（例如，幻灯片、视频）和 PES 邀请辅助工具（明信片、数字应用程序提醒）。
在全球临床研究中开发和部署顺序 PES 是可行的。三部分在线 PES（每调查 25 至 37 个问题）通过了健康素养测试。为了便于基准测试，PES 包括核心问题（包括净推荐值问题）。PES 获得了伦理批准，并于 2017-2018 年在北美、欧洲和亚太地区的 12 项 2 期和 3 期临床研究中全球部署。根据实际经验获得的见解和遇到的挑战，我们对 PES 提出了建议。
我们关于顺序全球 PES 的开发和部署的实用建议可能有助于其他人高效有效地实施 PES，使他们能够在临床研究期间从全球患者那里获得反馈。
