Department of Pharmaceutical Health Services Research, University of Maryland School of Pharmacy, Baltimore, MD 21201, USA.
The PATIENTS Program, University of Maryland, Baltimore, MD 21201, USA.
Future Oncol. 2021 Oct;17(28):3691-3704. doi: 10.2217/fon-2021-0556. Epub 2021 Aug 2.
Oncology trials are the cornerstone of effective and safe therapeutic discoveries. However, there is increasing demand for pragmatism and patient engagement in the design, implementation and dissemination of oncology trials. Many researchers are uncertain about making trials more practical and even less knowledgeable about how to meaningfully engage patients without compromising scientific rigor to meet regulatory requirements. The present work provides practical guidance for addressing both pragmaticism and meaningful patient engagement. Applying evidence-based approaches like PRECIS-2-tool and the 10-Step Engagement Framework offer practical guidance to make future trials in oncology truly pragmatic and patient-centered. Consequently, such patient-centered trials have improved participation, faster recruitment and greater retention, and uptake of innovative technologies in community-based care.
肿瘤学试验是有效和安全治疗发现的基石。然而，在肿瘤学试验的设计、实施和传播中，越来越需要务实和患者参与。许多研究人员不确定如何使试验更具实用性，甚至更不清楚如何在不影响科学严谨性以满足监管要求的情况下，有意义地让患者参与进来。本工作为解决务实性和有意义的患者参与问题提供了实用指导。应用基于证据的方法，如 PRECIS-2 工具和 10 步参与框架，为未来的肿瘤学试验提供了实用指导，使其真正具有务实性和以患者为中心。因此，这种以患者为中心的试验提高了参与度、加快了招募速度和提高了保留率，并在社区护理中采用了创新技术。
