Past Event
日期
2024 年 4 月 18 - 20 日
Location
Zhaolin Grand Hotel, Beijing
Booth 1
第五届监管-生物统计学术年会
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Biostatistics and Programming
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Protocol Development, including clinical trial design, sample size calculations, SAP summaries
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SAP, TFLs, dataset and data transfer
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Study Monitoring, including DSMB, Interim Analyses
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Data Analysis, including CDISC SDTM, ADaM, and SEND dataset programming
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Pooling strategy for ISS/ISE, CDISC define.xml and other e-submission components
真实世界数据解决方案
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量化机遇：未满足的需求、治疗模式、疾病负担、市场规模
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证明访问的合理性：成本最小化、成本抵消、成本效益和预算影响分析、患者/护理人员/社会视角
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衡量绩效：药物利用研究、相对有效性、结果绩效、授权后疗效研究 (PAES)
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确保安全：效益/风险评估、风险管理、信号检测、授权后安全性研究 (PASS)
