日本对正在进行的全球儿童癌症临床试验的贡献:东京国立癌症中心医院(NCCH)的经验

Miho Nakajima, Ayumu Arakawa, Chitose Ogawa
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引用次数: 0

摘要

欧洲和美国的法律规定必须开发儿科肿瘤药物,相比之下,日本开展的临床试验较少。这可能导致药物开发严重滞后,尤其是在治疗小儿实体瘤方面。值得注意的是,监管机构和政府已经开始讨论如何缓解日本儿科肿瘤药物滞后问题的策略。在过去十年中,我们通过日本参与 ACCELERATE 及其前身组织,积极寻求参与国际合作临床试验的机会。这一做法旨在解决上述问题,同时也与日本正在推行的医疗集中化和基因组医学的进步相吻合。在 ACCELERATE 计划的启发下,应患者权益团体对儿科肿瘤新药的要求,日本于 2021 年建立了首个儿科肿瘤支持平台--全国儿童癌症联盟(N3C)。N3C 由患者权益团体、产业界和学术界组成。这项工作概述了日本儿科药物开发的现状,并重点介绍了 NCCH 通过 ACCELERATE 参与全球临床试验的初步成功经验,从而实现了快速准备和患者招募。包括日本在内的亚洲国家参与全球合作临床试验可能会使制药公司和参与国共同受益,从而推动儿科肿瘤药物的开发。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Japan’s contribution to an ongoing global pediatric cancer clinical trial: The experience of the National Cancer Center Hospital (NCCH) in Tokyo

Compared to Europe and the United States, where the development of pediatric oncology drugs is mandated by law, Japan hosts fewer clinical trials. This can lead to a significant drug lag, especially in the case of treatments for pediatric solid tumors. Notably, regulatory authorities and the government have initiated discussions on strategies to mitigate Japan’s drug lag problem in pediatric oncology. Over the past decade, we have actively sought opportunities to participate in international collaborative clinical trials through Japan’s involvement in ACCELERATE and its predecessor organizations. This approach has aimed to address the issue above, coinciding with the ongoing centralization of medical care and advancements in genomic medicine, among other systems that support pediatric cancer care in Japan. Inspired by the ACCELERATE initiatives and in response to patient advocacy groups’ requests for new pediatric oncology drugs, Japan established its inaugural pediatric oncology support platform in 2021, the National Childhood Cancer Consortium (N3C). N3C comprises patient advocacy groups, industries, and academia. This work outlines the current status of pediatric drug development in Japan and highlights the initial successful experience of NCCH’s participation in a global clinical trial through ACCELERATE resulting in rapid preparation and patient recruitment. Participation of Asian countries including Japan in global collaborative clinical trials may benefit both pharmaceutical companies and the participating countries partnering to advance the development of pediatric oncology drugs.

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