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Veeva:2026年全球医药行业临床数据趋势报告(英文版)(14页).pdf

上传人: 小*** 编号:1234198 2026-05-09 14页 2.25MB

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1、REPORT2026 Clinical Data Trend Report2026 Clinical Data Trend Report2Table of ContentsOutlook for 2026:New Forces Driving Impactful Innovation.3Trends reshaping clinical data.41.Risk-based data management theory needs to become reality.42.Automated orchestration will become core to the clinical data

2、 management role.63.Smart automation and meaningful AI are ready to deliver ROI.74.Were moving from all-encompassing MDR to leveraging core standards better.85.Study design is incorporating patient optionality and site capability.96.Sponsors and sites are working to remove transcription.11Emerging t

3、rends to watch.127.ICH E6(R3)demands innate traceability and drives proportionality.128.Endpoint-driven design enables RBDM.129.Deeper focus on eCOA data reliability and integrity.1310.Boosting data management resilience and future economics.142026 Clinical Data Trend Report3In clinical data,there i

4、s often a lag between a new technology becoming available and its widespread adoption and return on investment(ROI).For instance,it took about a decade before most of our industry regularly used electronic data capture(EDC)during clinical trials instead of paper.Instead of signifying caution about e

5、mbracing innovation,these delays show that it takes time to develop new processes and embed change management,and to overcome risk aversion in our highly regulated industry.Today we believe there are six key trends to follow closely,each of which already has real use cases.Along with four emerging t

6、rends,we anticipate they will reshape clinical data in years to come.A unifying theme across these ten trends is the notion of“simplify and standardize”.This applies focus to the increased complexity in the clinical landscape and drives us toward impactful innovation that gives us more value with le

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1. **六大趋势重塑临床数据**:风险导向数据管理(RBDM)需落地(57%数据管理者认为将影响其角色)、自动化编排成核心、智能自动化与AI ready交付ROI、从“全面”MDR转向核心标准、研究设计纳入患者选择性与中心能力、消除转录。 2. **四大新兴趋势**:ICH E6(R3)要求内在可追溯性与比例性、终点驱动设计赋能RBDM、深化eCOA数据可靠性、提升数据管理韧性。 3. **核心主题**:“简化与标准化”,通过跨职能协作与智能创新(如AI+规则自动化)提升价值、降低风险,加速试验进程。
RBDM如何落地? AI如何提效? 数据如何简化?
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