IQVIA, 3 Forbury Place, 23 Forbury Road, Reading, RG1 2JH, UK.
IQVIA, Pittsburgh, USA.
Patient. 2021 Jan;14(1):11-16. doi: 10.1007/s40271-020-00455-2. Epub 2020 Oct 13.
The era of patient-focused drug development (PFDD) brings with it a greater use of patient-reported outcome measures (PROMs) in clinical trials. This is facilitated through electronic technology designed to capture PROM data. However, PFDD goes beyond just PROMs, and technology has a key role in capturing timely and patient-relevant information through active and passive means to inform study endpoints. This brief paper aims to highlight four trends the authors have observed across the pharmaceutical industry in using technology to enhance PFDD: (1) capturing qualitative data from patients; (2) using digital health technology tools (DHTTs); (3) employing reactive technology-enabled clinical outcome assessments TeCOA; and (4) generating passive patient experience data. Opportunities and challenges associated with these trends are discussed, and a 'call to action' is made to consolidate learning and understanding across science, medical and technology disciplines, and to conduct collaborative research to improve the opportunities and minimize the challenges.
以患者为中心的药物研发（PFDD）时代带来了临床试验中更多地使用患者报告结局测量（PROMs）。这得益于旨在捕获 PROM 数据的电子技术。然而，PFDD 不仅仅是 PROMs，技术在通过主动和被动手段捕获及时且与患者相关的信息以告知研究终点方面发挥着关键作用。本文旨在强调作者在制药行业中观察到的使用技术增强 PFDD 的四个趋势：（1）从患者那里捕获定性数据；（2）使用数字健康技术工具（DHTTs）；（3）使用反应性技术启用的临床结局评估 TeCOA；以及（4）生成被动患者体验数据。讨论了这些趋势相关的机遇和挑战，并呼吁采取行动，在科学、医学和技术学科之间巩固学习和理解，并开展合作研究，以提高机遇，减少挑战。
