Tufts Center for the Study of Drug Development, Tufts University School of Medicine, 145 Harrison Ave, Boston, MA, 02111, USA.
Drug Information Association, Washington, DC, USA.
Ther Innov Regul Sci. 2023 Sep;57(5):1040-1049. doi: 10.1007/s43441-023-00545-x. Epub 2023 Jun 19.
Consistent implementation and measurement of patient engagement initiatives across the industry have remained aspirational and elusive despite strong interest in adopting patient-centric approaches. One factor contributing to this inertia stems from a lack of standardized implementation of patient engagement activities, which varies widely from company to company, making it difficult to track and measure. Further, empirical evidence mapping the impact of patient engagement capabilities on clinical research outcomes has remained sparse. To address this gap, the Drug Information Association (DIA) and Tufts Center for the Study of Drug Development (Tufts CSDD) at the Tufts University School of Medicine developed and administered an assessment tool that companies can use to not only evaluate their organization's patient engagement capabilities and implementation preparedness but can also measure the impact of such activities on trial outcomes. Results showed that while most organizations are providing logistical support to increase patient engagement in the form of travel stipends, accommodation, and financial incentives, most are not implementing more involved forms of patient engagement such as gathering patient input through patient input panels or patient steering committees. This paper discusses the process for designing and administering this assessment tool, the results of the assessment, and future implications.
尽管人们对采用以患者为中心的方法有着浓厚的兴趣,但整个行业仍然难以实现并衡量患者参与计划的持续实施和测量。导致这种惰性的一个因素是患者参与活动的实施缺乏标准化,不同公司之间差异很大,因此难以跟踪和衡量。此外,关于患者参与能力对临床研究结果影响的实证证据仍然很少。为了解决这一差距,药物信息协会(DIA)和塔夫茨大学医学院的塔夫茨药物开发研究中心(Tufts CSDD)开发并管理了一种评估工具,公司可以使用该工具不仅评估其组织的患者参与能力和实施准备情况,还可以衡量此类活动对试验结果的影响。结果表明,虽然大多数组织正在提供后勤支持,以旅行津贴、住宿和经济激励的形式增加患者参与度,但大多数组织并未实施更深入的患者参与形式,例如通过患者输入小组或患者指导委员会收集患者意见。本文讨论了设计和管理这种评估工具的过程、评估的结果以及未来的影响。