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Apr 12, 2017

使用JMP Clinical进行有效的临床试验数据监测:设想、应用及药厂与CRO的合作_赵桂玉与彭瑞玲

 演讲嘉宾:

  • 赵桂玉博士,华领医药,临床研究与开发部医学数据科学,负责人
  • 彭瑞玲女士,北京医普科诺科技有限公司,总经理

Speaker:

  • Guiyu Zhao, Head of Medical Data Science, Department of Clinical Discovery and Development, Hua Medicine
  • Ruiling Peng, Founder, Beijing Puke Kono Technology

 

 

主题:使用 JMP® Clinical 进行有效的临床试验数据监测:设想、应用及药厂和CRO的合作

Topic: Effective Data Monitoring in Clinical Trials Using JMP® Clinical: Proposal, Application and Collaboration Between Pharma and CRO

 

摘要:

1. JMP Clinical在临床试验数据审核中的作用:强大的可视化功能 

  • 互动型的图形有助于从多角度审阅受试者的状况,揭示药物-药物以及药物-疾病之间的深层关系
  • 有助于内部数据监查员以及审评机构快速并全面的理解和评估临床试验数据
  • 利于医生和统计师之间的沟通,以及后续的申办方和审评机构之间的沟通

2. JMP Clinical在临床试验数据质量监测中的作用:试验进行中的监查

  • 医学/药物安全监测
  • 质量保证
  • 基于风险的质量监查
  • 数据质量监测计划的搭建:与合作方的密切合作

3. 突出案例:医学/药物安全监测,如不良事件的分析

  • 识别并深度挖掘不良事件中隐藏的逻辑和趋势
  • 揭示相关的因素
  • 信号探测:预测可能的发生率以及揭示潜在的风险
  • 为产品的下一步开发策略提供决策支持

 

Abstract: 

1. JMP Clinical in Clinical Trial Data Review: Adding Ways to Explore Clinical Data Visually

  • Interactive graphs offer multiple views of patient profiles and reveal hidden patterns in drug-drug and drug-disease interactions.
  • Provide rapid and comprehensive reviews of clinical trial data by both internal data monitors and regulatory bodies.
  • Facilitate communications between physicians and biostatisticians and, subsequently, between sponsors and reviewers.

2. JMP Clinical in Clinical Trial Data Quality Oversight: Monitoring the Ongoing Clinical Trials

  • Medical/safety monitoring.
  • Quality assessment.
  • Risk-based monitoring.
  • Data Oversight Plan Setup: Cooperate closely with CRO

3. Highlight Example: Medical/Safety Monitoring in JMP Clinical, Such as Adverse Event (AE) Analysis

  • Identify and closely examine hidden trends in AEs.
  • Reveal correlated factors.
  • Signal Detection: Predict possible occurrences and highlight potential risk.
  • Impact decision making for the next development stage.

 

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