研究动态
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患者积极参与肿瘤学研究。

The active involvement of patients in oncology research.

发表日期:2024 Nov
作者: Ursula Ganz-Blaettler, Sarah Jayne Liptrott, Angela Tolotti, Marco Cefalì, Christine Aeschlimann, Simona Berardi Vilei, Ilaria Colombo, Evi Hatziandreou, Thanos Kosmidis, Helena Linardou, Rosemarie Pfau, Stavroula Sgourou, Cristiana Sessa
来源: CANCER TREATMENT REVIEWS

摘要:

本综述的目的是概述肿瘤学研究中患者/公众参与(PPI)的现状,包括定义、监管方面、不同国家正在进行的临床活动、成就和困难。描述了瑞士临床癌症研究组织 (SAKK) 患者咨询委员会的 10 年活动,说明了日常实践中面临的挑战和解决方案。尽管临床数据仍然有限,但 PPI 在肿瘤学领域似乎具有巨大的发展潜力。精准医疗的推动、患者组织的活动、制药行业的兴趣以及监管机构的大力支持,都是 PPI 在整个药物开发过程中整合的促进因素。尽管有指导文件为 PPI 的实施提供建议,但缺乏人力和结构资源、患者/护理人员和医护人员的培训以及利益相关者之间缺乏合作是报告的一些主要障碍。临床研究中需要更严格的 PPI 报告,包括评估 PPI 影响的方法以及将患者作为合作伙伴的代表。版权所有 © 2024 作者。由爱思唯尔有限公司出版。保留所有权利。
The aim of this review is to provide an overview of the status of patient/public involvement (PPI) in oncology research, including definitions, regulatory aspects, ongoing clinical activities in different countries, achievements and difficulties. The 10-year activities of the Swiss Group for Clinical Cancer Research (SAKK) Patient Advisory Board are described, illustrating challenges faced and solutions in daily practice. Even though clinical data are still limited, it appears PPI has great potential for development in oncology. The drive for precision medicine, activities of patient organizations, pharmaceutical industry interest, and strong support from regulatory agencies, are facilitators to integration of PPI throughout the drug development process. Despite the availability of guidance documents providing recommendations for the implementation of PPI, lack of human and structural resources, training for patients / caregivers and healthcare personnel, and lack of collaboration among stakeholders are some of the main barriers reported. More rigorous reporting of PPI in clinical studies is needed, including the methods to evaluate the impact of PPI and in the representation of patients as partner.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.