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将患者的输入纳入目标产品配置文件
Jean-Noel Talabardon1, Janet E Church2, Masanori Okuse3
1Novartis Pharma AG, Asklepios Building - 5th Floor, Novartis Campus, 4056, Basel, Switzerland. jean-noel.talabardon@novartis.com.
本研究概述了药物开发中以患者为中心的目标产品概况 (TPP) 的框架. 早期纳入患者见解可以确保治疗满足患者需求并获得监管部门的批准.
科学领域:
- 药物开发和监管科学 药物开发和监管科学
- 以患者为中心的研究方法研究方法.
- 健康研究成果研究结果
背景情况:
- 目标产品概况 (TPP) 指导药物开发,但往往缺乏全面的患者投入.
- 患者的观点对于确定治疗成功和市场可行性至关重要.
- 现有的TPP开发流程可能无法系统地整合患者的专业知识.
研究的目的:
- 制定一个系统的指导框架,以创建以患者为中心,标准化的TPP.
- 在TPP中确定患者观点至关重要的关键领域.
- 为与患者社区接触的研发组织提供可行的建议.
主要方法:
- 一个指导框架的代开发与患者社区验证.
- 确定患者输入的五个核心TPP重点领域:目标人群,未满足的需求,剂量,疗效终点和益处/风险.
- 审查获取患者观点的工具 (例如,咨询委员会,采访).
主要成果:
- 为以患者为中心的TPP制定了一个系统的指导框架.
- 确定了五个基本的重点领域,用于TPP患者的输入.
- 强调了有效的研发与患者代表互动的关键要求,包括清晰的语言和尊重.
结论:
- 早期和系统地将患者的观点纳入TPP中,对于成功的药物开发至关重要.
- 结构化方法提高了患者投入的价值,导致更好地协调和可批准的药物产品.
- 赋予患者组织适应这些流程的权力,可以扩大他们在药物开发中的影响力.
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