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包郵 萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景
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萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景 版權(quán)信息
- ISBN：9787523512265
- 條形碼：9787523512265 ; 978-7-5235-1226-5
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萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景 本書(shū)特色
近年來(lái)臨床試驗(yàn)數(shù)據(jù)量呈指數(shù)級(jí)增加，臨床相關(guān)人員在數(shù)據(jù)審閱和分析過(guò)程中遇到了新的挑戰(zhàn)。一方面要求將分析結(jié)果精準(zhǔn)地傳達(dá)給決策者以輔助試驗(yàn)的策略制定；另一方面要求加速有效信息獲取來(lái)幫助改善患者的治療效果。使用合理的可視化工具，同時(shí)基于豐富的可視化模型進(jìn)行數(shù)據(jù)審核和分析，能 輕松地揭示數(shù)據(jù)關(guān)系，實(shí)時(shí)顯示數(shù)據(jù)狀態(tài)， 容易呈現(xiàn)出數(shù)據(jù)模式和數(shù)據(jù)趨勢(shì)。為了 好地提高數(shù)據(jù)的利用率，本書(shū)從臨床上的十大場(chǎng)景出發(fā)，對(duì)數(shù)據(jù)可視化的技術(shù)進(jìn)行分析、探討和實(shí)踐分享，從可視化需求、技術(shù)現(xiàn)狀及可及性、可視化的應(yīng)用場(chǎng)景、通用原則等維度進(jìn)行理論和實(shí)踐案例的闡述和分享。
萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景 內(nèi)容簡(jiǎn)介
近年來(lái)臨床試驗(yàn)數(shù)據(jù)量呈指數(shù)級(jí)增加，臨床相關(guān)人員在數(shù)據(jù)審閱和分析過(guò)程中遇到了新的挑戰(zhàn)。一方面要求將分析結(jié)果精準(zhǔn)地傳達(dá)給決策者以輔助試驗(yàn)的策略制定；另一方面要求加速有效信息獲取來(lái)幫助改善患者的治療效果。使用合理的可視化工具，同時(shí)基于豐富的可視化模型進(jìn)行數(shù)據(jù)審核和分析，能更輕松地揭示數(shù)據(jù)關(guān)系，實(shí)時(shí)顯示數(shù)據(jù)狀態(tài)，更容易呈現(xiàn)出數(shù)據(jù)模式和數(shù)據(jù)趨勢(shì)。 為了更好地提高數(shù)據(jù)的利用率，本書(shū)從臨床上的十大場(chǎng)景出發(fā)，對(duì)數(shù)據(jù)可視化的技術(shù)進(jìn)行分析、探討和實(shí)踐分享，從可視化需求、技術(shù)現(xiàn)狀及可及性、可視化的應(yīng)用場(chǎng)景、通用原則等維度進(jìn)行理論和實(shí)踐案例的闡述和分享。
萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景 目錄
第 1章 臨床運(yùn)營(yíng)可視化 ·············································································1
1.1 項(xiàng)目管理的工作職責(zé)和內(nèi)容 ············································································· 2
1.1.1 項(xiàng)目管理的定義·················································································2
1.1.2 項(xiàng)目管理的工作內(nèi)容 ··········································································2
1.2 項(xiàng)目管理可視化應(yīng)用的場(chǎng)景 ············································································· 3
1.2.1 項(xiàng)目進(jìn)度管理····················································································3
1.2.2 項(xiàng)目成本管理·················································································· 11
1.2.3 質(zhì)量管理 ······················································································· 17
1.2.4 人員管理 ······················································································· 21
1.2.5 項(xiàng)目文檔管理·················································································· 24
1.2.6 項(xiàng)目中的監(jiān)查和遠(yuǎn)程智能監(jiān)查的可視化管理 ············································ 26
1.3 項(xiàng)目管理中的自定義報(bào)表分析 ·········································································30
1.4 可視化工具在項(xiàng)目管理中的挑戰(zhàn) ······································································31
第 2章 RBQM數(shù)據(jù)可視化 ······································································· 33
2.1 概述 ·········································································································34
2.1.1 基于風(fēng)險(xiǎn)的質(zhì)量管理的基本介紹 ··························································· 34
2.1.2 數(shù)據(jù)可視化對(duì)基于質(zhì)量的風(fēng)險(xiǎn)管理的作用 ··············································· 35
2.2 風(fēng)險(xiǎn)評(píng)估與分類(lèi)（RAC） ··············································································36
2.2.1 應(yīng)用場(chǎng)景 ······················································································· 36
2.2.2 數(shù)據(jù)源 ·························································································· 37
2.2.3 可視化應(yīng)用 ····················································································· 37
萬(wàn)物可“視”臨床研發(fā)可視化應(yīng)用十大場(chǎng)景
2.3 質(zhì)量風(fēng)險(xiǎn)容忍度（QTL） ·············································································· 39
2.3.1 應(yīng)用場(chǎng)景 ······················································································· 39
2.3.2 數(shù)據(jù)源 ·························································································· 39
2.3.3 可視化應(yīng)用 ····················································································· 39
2.4 關(guān)鍵風(fēng)險(xiǎn)指標(biāo)（KRI） ·················································································· 40
2.4.1 應(yīng)用場(chǎng)景 ······················································································· 40
2.4.2 數(shù)據(jù)源 ·························································································· 40
2.4.3 可視化應(yīng)用 ····················································································· 40
2.4.4 案例 ····························································································· 42
2.4.5 統(tǒng)計(jì)學(xué)考量 ····················································································· 43
2.5 中心化統(tǒng)計(jì)監(jiān)查（CSM） ·············································································· 44
2.5.1 應(yīng)用場(chǎng)景 ······················································································· 44
2.5.2 數(shù)據(jù)源 ·························································································· 44
2.5.3 可視化應(yīng)用 ····················································································· 44
2.5.4 案例 ····························································································· 47
2.6 基于風(fēng)險(xiǎn)的質(zhì)量管理可視化的展望 ··································································· 47
第 3章 臨床數(shù)據(jù)管理可視化 ····································································· 49
3.1 臨床數(shù)據(jù)管理工作主要內(nèi)容介紹 ······································································ 50
3.2 CRF采集數(shù)據(jù)庫(kù)設(shè)計(jì)和測(cè)試場(chǎng)景 ····································································· 51
3.2.1 從方案到 Mock CRF流程自動(dòng)化 ··························································· 51
3.2.2 自動(dòng)化數(shù)據(jù)核查計(jì)劃（DVP）設(shè)計(jì) ························································ 52
3.2.3 用戶(hù)接受測(cè)試（UAT）自動(dòng)化 ······························································ 52
3.2.4 相關(guān)數(shù)據(jù)統(tǒng)計(jì)報(bào)告 ············································································ 52
3.2.5 自動(dòng)化工具 ····················································································· 53
3.3 數(shù)據(jù)錄入可視化應(yīng)用的場(chǎng)景 ············································································ 54
3.3.1 中心層面的數(shù)據(jù)質(zhì)量監(jiān)測(cè) ··································································· 55
3.3.2 受試者層面的數(shù)據(jù)質(zhì)量監(jiān)測(cè) ································································ 57
3.3.3 基于數(shù)據(jù)質(zhì)量的動(dòng)態(tài)數(shù)據(jù)清理 ····························································· 59
3.4 數(shù)據(jù)審核可視化應(yīng)用的場(chǎng)景 ············································································ 60
3.4.1 數(shù)據(jù)邏輯核查·················································································· 60
3.4.2 數(shù)據(jù)一致性核查··············································································· 64
3.5 數(shù)據(jù)管理可視化挑戰(zhàn)與展望 ············································································ 65
第 4章 醫(yī)學(xué)監(jiān)查可視化 ··········································································· 67
4.1 醫(yī)學(xué)監(jiān)查的工作職責(zé)和目的 ············································································68
4.2 入組審核可視化場(chǎng)景·····················································································68
4.3 醫(yī)學(xué)數(shù)據(jù)核查可視化場(chǎng)景 ···············································································71
4.3.1 醫(yī)學(xué)重點(diǎn)關(guān)注的錄入邏輯核查 ····························································· 71
4.3.2 不良事件的醫(yī)學(xué)核查 ········································································ 72
4.3.3 實(shí)驗(yàn)室數(shù)據(jù)的核查 ············································································ 75
4.3.4 禁用藥物數(shù)據(jù)核查 ············································································ 76
4.3.5 合并治療的核查··············································································· 77
4.4 關(guān)鍵臨床終點(diǎn)的可視化監(jiān)查 ············································································78
4.5 方案偏離審核的可視化··················································································80
第 5章 統(tǒng)計(jì)分析可視化 ··········································································· 83
5.1 統(tǒng)計(jì)分析可視化適用的場(chǎng)景 ············································································84
5.2 臨床試驗(yàn)設(shè)計(jì)的信息處理 ···············································································85
5.2.1 分布的判斷及研究參數(shù)的擬合 ····························································· 86
5.2.2“優(yōu)勢(shì)”的判斷·················································································· 88
5.2.3 早期臨床試驗(yàn)階段的研究路徑 ····························································· 89
5.2.4 薈萃分析 ······················································································· 90
5.2.5 決策樹(shù) ·························································································· 91
5.3 試驗(yàn)設(shè)計(jì)的要素選擇·····················································································92
5.3.1 研究終點(diǎn)及分層因素 ········································································· 92
5.3.2 伴發(fā)事件及處理策略 ········································································· 93
5.3.3 樣本量計(jì)算的可視化決策 ··································································· 95
5.4 試驗(yàn)過(guò)程中的數(shù)據(jù)評(píng)估和數(shù)據(jù)追蹤 ··································································95
5.4.1 支持臨床運(yùn)營(yíng)和醫(yī)學(xué)監(jiān)查 ··································································· 95
5.4.2 支持（盲態(tài)）數(shù)據(jù)審核會(huì) ··································································· 96
5.5 支持SRC、DMC、CSR的試驗(yàn)數(shù)據(jù)統(tǒng)計(jì)分析圖表 ·············································98
第 6章 注冊(cè)申報(bào)可視化管理 ····································································101
6.1 可視化在注冊(cè)項(xiàng)目多項(xiàng)目管理中的應(yīng)用 ··························································· 102
6.2 可視化在注冊(cè)項(xiàng)目中多團(tuán)隊(duì)協(xié)調(diào)中的應(yīng)用························································ 104
萬(wàn)物可“視”臨床研發(fā)可視化應(yīng)用十大場(chǎng)景
6.3 可視化在輔助注冊(cè)策略制定中的應(yīng)用 ······························································ 105
6.4 可視化在注冊(cè)外包商管理中的應(yīng)用 ································································· 109
6.5 如何實(shí)現(xiàn)注冊(cè)信息可視化 ············································································· 110
6.6 注冊(cè)申報(bào)可視化的挑戰(zhàn)與展望總結(jié) ··································································111
第 7章 臨床藥理和定量藥理可視化 ···························································113
7.1 臨床藥理在臨床試驗(yàn)中的應(yīng)用 ······································································· 114
7.2 可視化在臨床藥理相關(guān)研究設(shè)計(jì)中的應(yīng)用 ························································· 115
7.2.1 單劑劑量遞增（SAD）/多劑劑量遞增（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 可視化在臨床藥理和定量藥理的分析方法中的應(yīng)用 ············································· 118
7.3.1 PK非房室模型分析（Non-Compartment Analysis，NCA） ···························118
7.3.2 群體藥代動(dòng)力學(xué)（Population PK，PopPK）分析 ·······································118
7.3.3 E-R分析 ······················································································121
7.4 定量系統(tǒng)藥理學(xué) ························································································ 122
第 8章 藥物經(jīng)濟(jì)學(xué)可視化 ·······································································125
8.1 什么是藥物經(jīng)濟(jì)學(xué) ····················································································· 126
8.2 藥物經(jīng)濟(jì)學(xué)的研究?jī)?nèi)容 ················································································ 126
8.3 藥物經(jīng)濟(jì)學(xué)在醫(yī)學(xué)決策中的應(yīng)用及其可視化展示 ················································ 126
8.3.1 醫(yī)藥 ····························································································126
8.3.2 醫(yī)療 ····························································································131
8.3.3 醫(yī)保 ····························································································132
第 9章 安全風(fēng)險(xiǎn)信號(hào)監(jiān)測(cè)可視化 ······························································137
9.1 安全風(fēng)險(xiǎn)信號(hào)相關(guān)概念 ················································································ 138
9.2 信號(hào)的來(lái)源 ······························································································ 138
9.3 信號(hào)監(jiān)測(cè)流程 ··························································································· 138
9.3.1 信號(hào)監(jiān)測(cè)策略制定考量因素 ·······························································140
9.3.2 信號(hào)監(jiān)測(cè)頻率制定 ···········································································140
9.3.3 重點(diǎn)關(guān)注信號(hào) ·················································································140
9.3.4 信號(hào)優(yōu)先級(jí)判定可考慮因素 ·······························································141
9.3.5 信號(hào)監(jiān)測(cè)執(zhí)行 ·················································································141
9.4 信號(hào)驗(yàn)證流程 ··························································································· 149
第 10章 真實(shí)世界數(shù)據(jù)及真實(shí)世界研究可視化 ·············································153
10.1 真實(shí)世界研究概述 ···················································································· 154
10.1.1
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萬(wàn)物可“視”:臨床研發(fā)可視化應(yīng)用十大場(chǎng)景 作者簡(jiǎn)介
李高揚(yáng)，羚研創(chuàng)新（北京）健康科技創(chuàng)始人，DIA中國(guó)數(shù)字健康社區(qū)負(fù)責(zé)人。2008年畢業(yè)于南京大學(xué)生命科學(xué)學(xué)院，獲得碩士學(xué)位。從事臨床研究15年，超過(guò)10年主要聚焦統(tǒng)計(jì)分析工作，領(lǐng)導(dǎo)開(kāi)發(fā)了悟空可視化平臺(tái)，并發(fā)表多篇醫(yī)藥研發(fā)領(lǐng)域交互式可視化應(yīng)用的專(zhuān)業(yè)文章。主編和參與編寫(xiě)《遠(yuǎn)程智能臨床試驗(yàn)藍(lán)皮書(shū)》《遠(yuǎn)程智能臨床試驗(yàn)專(zhuān)家共識(shí)》《遠(yuǎn)程智能臨床試驗(yàn)》《中醫(yī)臨床真實(shí)世界研究》《智能無(wú)人系統(tǒng)產(chǎn)業(yè)發(fā)展報(bào)告》等多部專(zhuān)業(yè)著作，參與《中國(guó)食品藥品監(jiān)管》“藥械監(jiān)管科學(xué)創(chuàng)新技術(shù)研究專(zhuān)刊”出版工作。同時(shí)，組織臨床研發(fā)數(shù)字化研討會(huì)，協(xié)調(diào)撰寫(xiě)藍(lán)皮書(shū)、共識(shí)、文章等，長(zhǎng)期協(xié)助監(jiān)管機(jī)構(gòu)起草數(shù)字化相關(guān)技術(shù)指導(dǎo)原則，促進(jìn)醫(yī)藥研發(fā)數(shù)字化轉(zhuǎn)型。先后獲得DIA數(shù)字健康社區(qū)（DHC）未來(lái)領(lǐng)袖獎(jiǎng)（2020年度）和創(chuàng)新領(lǐng)導(dǎo)獎(jiǎng)（2024年度）。 廖珊妹，美國(guó)加州大學(xué)戴維斯分校統(tǒng)計(jì)博士，擁有近17年藥廠生物統(tǒng)計(jì)經(jīng)驗(yàn)。曾任職于BMS美國(guó)和輝瑞中國(guó)，現(xiàn)為百濟(jì)神州上市后及真實(shí)世界證據(jù)統(tǒng)計(jì)負(fù)責(zé)人。曾參與/領(lǐng)導(dǎo)多項(xiàng)新藥/生物類(lèi)似物研發(fā)及6項(xiàng)中/美注冊(cè)申報(bào)，負(fù)責(zé)過(guò)幾十項(xiàng)Ⅰ期至Ⅳ期臨床研究。疾病領(lǐng)域涉及實(shí)體瘤血液腫瘤、免疫、神經(jīng)、病毒、心血管、生物類(lèi)似物研發(fā)等。自2019年擔(dān)任百濟(jì)神州上市后統(tǒng)計(jì)負(fù)責(zé)人后，帶領(lǐng)團(tuán)隊(duì)支持了多項(xiàng)國(guó)內(nèi)外真實(shí)世界研究設(shè)計(jì)、確證性試驗(yàn)監(jiān)管機(jī)構(gòu)討論、醫(yī)保談判療效經(jīng)濟(jì)模型分析及監(jiān)管交流、真實(shí)世界數(shù)據(jù)庫(kù)及PRO分析報(bào)告支持上市產(chǎn)品證據(jù)鏈，以及上市后安全數(shù)據(jù)監(jiān)測(cè)。同時(shí)擔(dān)任中國(guó)DIA RWD工作組組長(zhǎng)、亦弘商學(xué)院統(tǒng)計(jì)學(xué)講者、NMPA高研院真實(shí)世界數(shù)據(jù)應(yīng)用講者、《中國(guó)食品藥品監(jiān)管》雜志特約審稿人等外部職務(wù)。 李蹊，DIA中國(guó)數(shù)字健康社區(qū)成員，映恩生物數(shù)據(jù)管理高級(jí)總監(jiān)，具有10年以上臨床研究領(lǐng)域從業(yè)經(jīng)驗(yàn)，曾就職于賽諾菲、Parexel、Viedoc、科倫等醫(yī)藥企業(yè)，有數(shù)據(jù)管理、數(shù)據(jù)編程、EDC建庫(kù)、數(shù)據(jù)庫(kù)系統(tǒng)開(kāi)發(fā)等經(jīng)驗(yàn)，具有南京大學(xué)生物化學(xué)和新加坡南洋理工信息技術(shù)雙碩士學(xué)位，發(fā)表過(guò)5篇SCI論文。
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