通过HTA机构的早期科学建议加强发展战略 - - 卫生技术开发商的经验,期望和最佳实践
1Centre for Innovation in Regulatory Science (CIRS), 70 St Mary Axe, London, EC3A 8BE, UK. twang@cirsci.org.
Therapeutic innovation & regulatory science
|August 2, 2025
概括
对于制药公司来说,早期健康技术评估 (HTA) 建议至关重要. 加强联合科学商 (JSC) 和利益相关方的参与将改善药物开发和患者的治疗结果.
科学领域:
- 医疗技术评估 (HTA) 是指对医疗技术进行评估.
- 制药政策 制药政策
- 药物开发 药物开发
背景情况:
- 早期健康技术评估 (HTA) 咨询帮助制药公司在药物开发中通过识别数据缺口和完善研究设计来帮助制药公司.
- 了解HTA机构的证据要求对于成功的药物开发途径至关重要.
研究的目的:
- 评估早期HTA咨询的风景,好处和挑战.
- 在欧盟HTA法规过渡期间,重点关注欧洲机构和全球实践.
主要方法:
- 对12家制药公司进行了一项关于与HTA机构合作的感知调查.
- 一个由22家公司代表组成的论坛,讨论最佳实践,联合科学商 (JSC),现实世界的证据 (RWE) 和患者报告的结果 (PRO).
主要成果:
- 积极参与NICE,G-BA和EUnetHTA联合行动.
- 尼斯 (NICE) 建议的价值是成本效益;英国脱欧影响了欧洲的合作.
- 根据欧盟HTA法规规定的JSC至关重要,但面临着资源和可用性挑战.
- 公司优先考虑比较者选择,结果和RWE,面临内部资源障碍.
- 欧洲以外的咨询服务的有限普及凸显了生命周期方法的潜力.
结论:
- 早期的HTA建议对于制药开发至关重要.
- 加强JSC的能力,利益相关者的参与和反机制是关键.
- 加强公司与HTA机构之间的协调,促进基于证据的决策,改善健康结果.
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