Informatics and Artificial Intelligence-Guided Assessment of the Regulatory and Translational Research Landscape of First-in-Class Oncology Drugs in the United States, 2018-2022.

IF 3.3 Q2 ONCOLOGY JCO Clinical Cancer Informatics Pub Date : 2024-10-01 DOI:10.1200/CCI.24.00087
Jay G Ronquillo, Brett South, Prakash Naik, Rominder Singh, Magdia De Jesus, Stephen J Watt, Aida Habtezion
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Abstract

Purpose: Cancer drug development remains a critical but challenging process that affects millions of patients and their families. Using biomedical informatics and artificial intelligence (AI) approaches, we assessed the regulatory and translational research landscape defining successful first-in-class drugs for patients with cancer.

Methods: This is a retrospective observational study of all novel first-in-class drugs approved by the US Food and Drug Administration (FDA) from 2018 to 2022, stratified by cancer versus noncancer drugs. A biomedical informatics pipeline leveraging interoperability standards and ChatGPT performed integration and analysis of public databases provided by the FDA, National Institutes of Health, and WHO.

Results: Between 2018 and 2022, the FDA approved a total of 247 novel drugs, of which 107 (43.3%) were first-in-class drugs involving a new biologic target. Of these first-in-class drugs, 30 (28%) treatments were indicated for patients with cancer, including 19 (63.3%) for solid tumors and the remaining 11 (36.7%) for hematologic cancers. A median of 68 publications of basic, clinical, and other relevant translational science preceded successful FDA approval of first-in-class cancer drugs, with oncology-related treatments involving fewer median years of target-based research than therapies not related to cancer (33 v 43 years; P < .05). Overall, 94.4% of first-in-class drugs had at least 25 years of target-related research papers, while 85.5% of first-in-class drugs had at least 10 years of translational research publications.

Conclusion: Novel first-in-class cancer treatments are defined by diverse clinical indications, personalized molecular targets, dependence on expedited regulatory pathways, and translational research metrics reflecting this complex landscape. Biomedical informatics and AI provide scalable, data-driven ways to assess and even address important challenges in the drug development pipeline.

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2018-2022年信息学和人工智能指导下的美国一流肿瘤药物监管和转化研究前景评估》(Informatics and Artificial Intelligence-Guided Assessment of the Regulatory and Translational Research Landscape of First-in-Class Oncology Drugs in the United States, 2018-2022)。
目的:癌症药物开发仍然是一个关键但极具挑战性的过程,影响着数百万患者及其家庭。利用生物医学信息学和人工智能(AI)方法,我们评估了为癌症患者成功定义首创药物的监管和转化研究情况:这是一项回顾性观察研究,研究对象是美国食品和药物管理局(FDA)从 2018 年到 2022 年批准的所有新型首创药物,并按癌症药物与非癌症药物进行了分层。生物医学信息学管道利用互操作性标准和 ChatGPT 对 FDA、美国国立卫生研究院和世卫组织提供的公共数据库进行了整合和分析:2018 年至 2022 年间,FDA 共批准了 247 种新型药物,其中 107 种(43.3%)是涉及新生物靶点的首创药物。在这些首创药物中,有30种(28%)治疗方法适用于癌症患者,其中19种(63.3%)适用于实体瘤,其余11种(36.7%)适用于血液肿瘤。在FDA成功批准一类抗癌药物之前,基础、临床和其他相关转化科学的中位数论文发表量为68篇,与癌症无关的疗法相比,肿瘤相关疗法的靶向研究中位数年数较少(33年v 43年;P < .05)。总体而言,94.4%的一类新药至少发表了25年的靶点相关研究论文,而85.5%的一类新药至少发表了10年的转化研究论文:结论:新的一流癌症治疗方法由多样化的临床适应症、个性化的分子靶点、对快速监管途径的依赖以及反映这一复杂情况的转化研究指标所定义。生物医学信息学和人工智能提供了可扩展、数据驱动的方法来评估甚至解决药物开发管道中的重要挑战。
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CiteScore
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4.80%
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190
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