Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Rd, Oxford, OX2 6GG, UK.
UCB Biopharma SRL, Allee de la Recherche 60, 1070, Brussels, Belgium.
Pharmaceut Med. 2023 Mar;37(2):129-138. doi: 10.1007/s40290-022-00458-4. Epub 2023 Jan 18.
The approach to patient engagement (PE) in drug development has changed rapidly due to many factors, including the complexity of innovative drugs and the need to demonstrate outcomes of relevance to patients, the desire to show 'value add' of PE, and the pandemic-related changes to how clinical trials are run, e.g., decentralised studies. In parallel, there have been changes in technology-assisted ways of running clinical trials, capturing patient health outcomes and preferences, an increasing societal demand for diversity and inclusion, and efforts to improve clinical trial efficiency, transparency, and accountability. Organisations are beginning to monitor PE activities and outcomes more effectively to learn and inform future PE strategies. As a result, these factors are facilitating the incorporation of patients' lived experience, preferences and needs into the design and running of clinical trials more than ever before. In this paper, the authors reflect upon these last few years, the emerging trends and their drivers, and where we may expect PE in clinical research to progress in the near future.
由于许多因素,包括创新药物的复杂性和需要展示对患者有意义的结果、展示患者参与(PE)的“附加值”的愿望,以及与大流行相关的临床试验开展方式的变化,例如去中心化研究,药物开发中患者参与的方法发生了快速变化。与此同时,技术辅助开展临床试验、捕捉患者健康结果和偏好的方式发生了变化,社会对多样性和包容性的需求不断增加,以及提高临床试验效率、透明度和问责制的努力也在不断增加。各组织开始更有效地监测 PE 活动和结果,以了解并为未来的 PE 策略提供信息。因此,这些因素正在以前所未有的方式促进将患者的生活体验、偏好和需求纳入临床试验的设计和实施中。在本文中,作者反思了过去几年的情况、新兴趋势及其驱动因素,以及我们可能期望患者参与在临床研究中的未来发展方向。