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ICON:2025AI赋能临床研发:AI在药物开发中的实战应用白皮书(英文版)(22页).pdf

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1、Integrating AI into clinical research:How AI is being used to enhance clinical developmentICON AI into clinical developmentExecutive summary 03Best practices in applying AI 05The AI regulatory landscape 08AI applications across the drug development lifecycle 09Early measures of effectiveness 11A wor

2、d about Generative AI 16Conclusion 17Authors 18 Further reading 19References 20 ContentsIntegrating AI into clinical development3As a disruptive technology,Artificial Intelligence(AI)is currently the subject of a great deal of excitement and hype so much so that it can be difficult to objectively as

3、sess its capabilities and promise.It is clear,though,that AI has the potential to transform business processes across the spectrum of clinical development from clinical trial design,through to recruitment and clinical operations,all the way to commercialisation and outcomes.AI can deliver reasonably

4、 unbiased and accurate insight into a situation,allowing human experts to make a clear decision.Human expertise should still be the final arbiter,but AI can have a very positive impact on the final outcome.While AI has engendered some degree of necessary caution in the pharmaceutical industry,adopti

5、on is steadily increasing.A 2024 global survey conducted by Tufts Center for the Study of Drug Development(Tufts CSDD)in conjunction with the Drug Information Association(DIA)found that 63%of respondents had at least begun to implement AI/Machine Learning(ML)to support drug development.Adoption rate

6、s were closely tied to trial volume.1 In our survey on digital disruption conducted with Citeline in late 2024,2 we learned that although companies are using AI heavily in single development programs,organisations are still struggling to incorporate the technology on a wider scale.While 70%of respon

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根据报告的内容,本文主要介绍了人工智能在临床研究中的应用,并强调了以下关键点: 1. **人工智能应用**:人工智能在临床研究中的应用范围广泛,包括优化临床试验设计、招募患者、提高医学写作效率、加速临床试验关闭等。 2. **人工智能监管环境**:全球范围内对人工智能的监管环境日益完善,欧盟已通过全球首部全面的人工智能法律,强调透明度、数据治理、伦理实践等。 3. **人工智能在药物开发周期中的应用**:人工智能在药物开发周期中发挥着重要作用,包括优化临床试验方案设计、开发新临床终点、实现虚拟试验组等。 4. **人工智能面临的挑战**:人工智能的成功应用高度依赖于大量高质量数据的获取,不同工具和数据的互操作性仍是主要障碍。 5. **人工智能在临床试验中的实际应用**:人工智能在临床试验中发挥着重要作用,包括选择和管理临床结果评估、识别合适的临床试验站点、预测上市后要求等。 6. **生成式人工智能的谨慎使用**:生成式人工智能需要经过微调和定制训练,并需要人类专家的监督,以避免潜在偏差。 7. **人工智能在临床试验中的广泛应用**:人工智能在临床试验中发挥着重要作用,包括选择和管理临床结果评估、识别合适的临床试验站点、预测上市后要求等。
AI在临床试验中扮演什么角色? 如何在临床试验中应用AI? AI在临床试验中面临哪些挑战?
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