癌症药物开发的监管视角:综述

Anurag Panchal, Pankaj Musyuni, Geeta Aggarwal
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引用次数: 0

摘要

尽管人们认为更好的技术和科学知识会带来更好的医疗服务,但事实却截然不同。尽管拥有最尖端的科学知识,但讽刺的是,美国和欧洲大部分地区的癌症发病率最高。它表明,仅仅利用技术和科学来治疗癌症和其他疾病是不够的。此外,现在人们普遍承认,大多数临床前肿瘤模型是不够的,因为95%以上在培养物中杀死癌细胞或在动物中减少肿瘤的物质和分子可能在人体临床研究中失败。此外,大多数由FDA等监管机构批准的抗癌药物要么对癌症患者的生存没有影响,要么可能会延长几个月。这是由于目前提供的大多数化疗药物非常昂贵,导致缺乏负担能力。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Regulatory perspective of cancer drug development: An overview
Despite the fact postulated that better technology and scientific knowledge will lead to better medical services, the truth is very distinctive. Despite having the most cutting-edge scientific knowledge, America and the majority of Europe ironically have the maximum cancer rates. It shows that using technology and science alone to treat cancer and other diseases is inadequate. Additionally, it is now widely acknowledged that majority of pre-clinical tumour models are insufficient, because more than 95% of substances and molecules that kill cancerous cells in culture or reduce tumours in animals may fail in clinical studies in people. Additionally, the majority of anti-cancer medications which are authorised by regulatory bodies like the FDA have either no impact on survival of cancer patients or may raise by a few months. This is amidst the fact that majority of presently offered chemotherapeutic drugs are very expensive, leading to a lack of affordability.
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