催化生物制药领导者:通过包容性参与,激发创新的药物
Cátia Bandeiras1, Leticia Murray2, Andria Cox3
1Novartis Ireland, Dublin, Ireland.
European journal of pharmacology
|June 25, 2025
概括
生物制药公司必须在整个药物生命周期中整合包容和参与原则,从研究到获取. 这种整体方法确保为所有患者群体开发安全有效的药物,改善全球健康结果.
科学领域:
- 生物制药药物的药物开发.
- 卫生公平性健康公平性
- 医学研究伦理学医学研究伦理学
背景情况:
- 生物制药行业努力满足尚未满足的医疗需求.
- 之前的审查已经在整个药物生命周期中单独检查了包括原则.
- 需要采取全面的方法来整合药物发现,开发和获取过程中的包容性和参与.
研究的目的:
- 为整个生物制药产品生命周期中应用包容和参与原则提供整体概述.
- 引导生物制药行业的领导者实施这些原则.
- 突出教育活动,指南和法规的作用.
主要方法:
- 对遗传异质性和具有代表性的临床前模型进行审查,以减轻偏差.
- 分析临床开发中的包容性参与和患者观点.
- 探索广泛获取,负担能力和医疗保健系统在批准后加强的原则.
- 审查包容性决策和教育合作,以发展劳动力.
主要成果:
- 解决遗传异质性和临床前偏差对于早期研究至关重要.
- 确保多样化的患者代表性,并纳入患者的观点,提高临床发展.
- 批准后的策略对于公平的获取和负担能力至关重要.
- 包容性决策和教育促进了全球能力强的劳动力.
结论:
- 在整个药物生命周期中整合包容性和参与,对于为所有人群开发安全有效的药物至关重要.
- 这种综合性策略改善了患者的治疗结果和生活质量.
- 生物制药行业的领导者可以利用这些原则来推动创新和健康公平.
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