万物可“视”——临床研发可视化应用十大场景

为了更好地提高数据的利用率，本书从临床上的十大场景出发，对数据可视化的技术进行分析、探讨和实践分享，从可视化需求、技术现状及可及性、可视化的应用场景、通用原则等维度进行理论和实践案例的阐述和分享。

百济神州生物科技有限公司是一家植根中国的全球性商业化生物制药公司，致力于成为分子靶向药物和免疫肿瘤药物研发及商业创新领域的全球领导者。目前，百济神州拥有37款商业化或临床阶段在研管线药物。是首家在中国和全球范围内同步开展注册性临床试验的创新药企。

\"第 1章　临床运营可视化 ·············································································1 1.1　项目管理的工作职责和内容 ············································································· 2 1.1.1　项目管理的定义·················································································2 1.1.2　项目管理的工作内容 ··········································································2 1.2　项目管理可视化应用的场景 ············································································· 3 1.2.1　项目进度管理····················································································3 1.2.2　项目成本管理·················································································· 11 1.2.3　质量管理 ······················································································· 17 1.2.4　人员管理 ······················································································· 21 1.2.5　项目文档管理·················································································· 24 1.2.6　项目中的监查和远程智能监查的可视化管理 ············································ 26 1.3　项目管理中的自定义报表分析 ·········································································30 1.4　可视化工具在项目管理中的挑战 ······································································31 第 2章　RBQM数据可视化 ······································································· 33 2.1　概述 ·········································································································34 2.1.1　基于风险的质量管理的基本介绍 ··························································· 34 2.1.2　数据可视化对基于质量的风险管理的作用 ··············································· 35 2.2　风险评估与分类（RAC） ··············································································36 2.2.1　应用场景 ······················································································· 36 2.2.2　数据源 ·························································································· 37 2.2.3　可视化应用 ····················································································· 37 万物可“视”临床研发可视化应用十大场景 2.3　质量风险容忍度（QTL） ·············································································· 39 2.3.1　应用场景 ······················································································· 39 2.3.2　数据源 ·························································································· 39 2.3.3　可视化应用 ····················································································· 39 2.4　关键风险指标（KRI） ·················································································· 40 2.4.1　应用场景 ······················································································· 40 2.4.2　数据源 ·························································································· 40 2.4.3　可视化应用 ····················································································· 40 2.4.4　案例 ····························································································· 42 2.4.5　统计学考量 ····················································································· 43 2.5　中心化统计监查（CSM） ·············································································· 44 2.5.1　应用场景 ······················································································· 44 2.5.2　数据源 ·························································································· 44 2.5.3　可视化应用 ····················································································· 44 2.5.4　案例 ····························································································· 47 2.6　基于风险的质量管理可视化的展望 ··································································· 47 第 3章　临床数据管理可视化 ····································································· 49 3.1　临床数据管理工作主要内容介绍 ······································································ 50 3.2　CRF采集数据库设计和测试场景 ····································································· 51 3.2.1　从方案到 Mock CRF流程自动化 ··························································· 51 3.2.2　自动化数据核查计划（DVP）设计 ························································ 52 3.2.3　用户接受测试（UAT）自动化 ······························································ 52 3.2.4　相关数据统计报告 ············································································ 52 3.2.5　自动化工具 ····················································································· 53 3.3　数据录入可视化应用的场景 ············································································ 54 3.3.1　中心层面的数据质量监测 ··································································· 55 3.3.2　受试者层面的数据质量监测 ································································ 57 3.3.3　基于数据质量的动态数据清理 ····························································· 59 3.4　数据审核可视化应用的场景 ············································································ 60 3.4.1　数据逻辑核查·················································································· 60 3.4.2　数据一致性核查··············································································· 64 3.5　数据管理可视化挑战与展望 ············································································ 65 第 4章　医学监查可视化 ··········································································· 67 4.1　医学监查的工作职责和目的 ············································································68 4.2　入组审核可视化场景·····················································································68 4.3　医学数据核查可视化场景 ···············································································71 4.3.1　医学重点关注的录入逻辑核查 ····························································· 71 4.3.2　不良事件的医学核查 ········································································ 72 4.3.3　实验室数据的核查 ············································································ 75 4.3.4　禁用药物数据核查 ············································································ 76 4.3.5　合并治疗的核查··············································································· 77 4.4　关键临床终点的可视化监查 ············································································78 4.5　方案偏离审核的可视化··················································································80 第 5章　统计分析可视化 ··········································································· 83 5.1　统计分析可视化适用的场景 ············································································84 5.2　临床试验设计的信息处理 ···············································································85 5.2.1　分布的判断及研究参数的拟合 ····························································· 86 5.2.2“优势”的判断·················································································· 88 5.2.3　早期临床试验阶段的研究路径 ····························································· 89 5.2.4　荟萃分析 ······················································································· 90 5.2.5　决策树 ·························································································· 91 5.3　试验设计的要素选择·····················································································92 5.3.1　研究终点及分层因素 ········································································· 92 5.3.2　伴发事件及处理策略 ········································································· 93 5.3.3　样本量计算的可视化决策 ··································································· 95 5.4　试验过程中的数据评估和数据追踪 ··································································95 5.4.1　支持临床运营和医学监查 ··································································· 95 5.4.2　支持（盲态）数据审核会 ··································································· 96 5.5　支持SRC、DMC、CSR的试验数据统计分析图表 ·············································98 第 6章　注册申报可视化管理 ····································································101 6.1　可视化在注册项目多项目管理中的应用 ··························································· 102 6.2　可视化在注册项目中多团队协调中的应用························································ 104 万物可“视”临床研发可视化应用十大场景 6.3　可视化在辅助注册策略制定中的应用 ······························································ 105 6.4　可视化在注册外包商管理中的应用 ································································· 109 6.5　如何实现注册信息可视化 ············································································· 110 6.6　注册申报可视化的挑战与展望总结 ··································································111 第 7章　临床药理和定量药理可视化 ···························································113 7.1　临床药理在临床试验中的应用 ······································································· 114 7.2　可视化在临床药理相关研究设计中的应用 ························································· 115 7.2.1　单剂剂量递增（SAD）/多剂剂量递增（MAD）研究 ·································115 7.2.2　生物等效性（BE）研究 ····································································116 7.2.3　肝功能不全患者的 PK研究 ································································117 7.3　可视化在临床药理和定量药理的分析方法中的应用 ············································· 118 7.3.1　PK非房室模型分析（Non-Compartment Analysis，NCA） ···························118 7.3.2　群体药代动力学（Population PK，PopPK）分析 ·······································118 7.3.3　E-R分析 ······················································································121 7.4　 定量系统药理学 ························································································ 122 第 8章　药物经济学可视化 ·······································································125 8.1　什么是药物经济学 ····················································································· 126 8.2　药物经济学的研究内容 ················································································ 126 8.3　药物经济学在医学决策中的应用及其可视化展示 ················································ 126 8.3.1　医药 ····························································································126 8.3.2　医疗 ····························································································131 8.3.3　医保 ····························································································132 第 9章　安全风险信号监测可视化 ······························································137 9.1　安全风险信号相关概念 ················································································ 138 9.2　信号的来源 ······························································································ 138 9.3　信号监测流程 ··························································································· 138 9.3.1　信号监测策略制定考量因素 ·······························································140 9.3.2　信号监测频率制定 ···········································································140 9.3.3　重点关注信号 ·················································································140 9.3.4　信号优先级判定可考虑因素 ·······························································141 9.3.5　信号监测执行 ·················································································141 9.4　信号验证流程 ··························································································· 149 第 10章　真实世界数据及真实世界研究可视化 ·············································153 10.1　真实世界研究概述 ···················································································· 154 10.1.1