临床试验和药物开发的未来:2050年
Timothy C Hardman1, Rob Aitchison2, Richard Scaife3
1Niche Science & Technology Ltd., Richmond-upon-Thames, Surrey, UK.
Drugs in context
|June 14, 2023
概括
到2050年,临床试验将以数据为导向,利用先进技术和新型新疗法三阶段注册模式. 临床试验专业人员的角色将向数据科学专业知识发展.
科学领域:
- 制药科学 制药科学
- 临床试验管理 临床试验管理
- 生物技术是生物技术.
背景情况:
- 在制药合同管理小组第18届年度会议上召开了一场研讨会,召集了200多名代表,讨论了2050年临床试验的未来.
- 关键问题包括新技术的影响,如健康芯片和可穿戴设备,人工智能的作用,以及临床研究助理的不断变化的责任.
研究的目的:
- 预测到2050年临床试验的情况.
- 识别新兴技术和制药行业中不断变化的角色的潜在影响.
主要方法:
- 专家的共识来自于一个涉及200多名代表的研讨会讨论.
- 探索制药开发,患者招募,试验设计和监管途径的未来趋势.
主要成果:
- 共识:到2050年,临床试验专业人员将主要是数据科学家.
- 预计新技术的整合将增加,以及治疗的新三阶段注册模式.
- 拟议的模型包括质量评估,针对安全性的适应性临床开发,以及与补偿机构合作的疗效评估.
结论:
- 临床试验的未来包括向数据科学和先进技术的重大转变.
- 设想一个新的三阶段注册过程,强调临床前建模,适应性安全试验和协作疗效/报销评估.
- 临床试验的精确演变将由赞助商,监管机构和付款人的创新塑造.
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