通过共享数据和生物标本来加强临床癌症研究
Hans Wildiers1, Virginie Adam2, Seamus O'Reilly3
1Department of General Medical Oncology, University Hospitals Leuven, Leuven, Belgium.
JAMA oncology
|December 18, 2025
概括
分享临床试验数据和生物样本对于个性化癌症治疗至关重要. 目前的共享实践是不理想的,需要像学术-病人共同领导和数据访问等战略,以改善患者护理.
科学领域:
- 在瘤学瘤学.
- 翻译研究是翻译研究.
- 生物标志物发现发现
背景情况:
- 对生物样本的分子分析是确定生物标记物的关键,以定制癌症治疗.
- 分享临床试验数据和生物样本加速了个性化医疗和新疗法开发.
研究的目的:
- 确定临床试验中数据和生物样本共享的障碍.
- 提出加强生物标志物研究的获取和合作的战略.
主要方法:
- 由监管机构批准的29项乳腺癌注册临床试验 (2017-2024) 的审查.
- 分析生物标志物研究出版率和对药物指示的影响.
- 来自53名学术研究人员和患者代表的专家意见.
主要成果:
- 来自注册试验的生物标志物研究很少限制药物适用性.
- 从这些试验中发表的生物标志物研究是罕见的,尽管参与者生物标本贡献.
- 在29项乳腺癌试验中,没有一项导致生物标志物研究,限制了药物的批准指示.
结论:
- 从注册试验中共享数据和生物标本的情况一直不理想.
- 加强共享需要多方利益相关方的方法,涉及学术界,患者和行业.
- 拟议的战略包括共同领导,明确同意共享数据,并访问生物标本进行独立研究.
相关概念视频
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Mice have long served as models for studying human biology and pathology because of their phylogenetic and physiological similarity with humans. They are also easy to maintain and breed in the laboratory, and hence, many inbred strains are now available for research. Studies on mice have contributed immeasurably to our understanding of cancer biology.
The development of transgenic, knockout, and knock-in mice has led to an exponential increase in their use as model organisms in research,...
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