泰格醫藥：2023數字化和去中心化臨床試驗行業發展現狀調研分析報告（43頁）.pdf

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1、1Customer-centric and globally adaptive DCT solutions Release date:2024.1.32023?/?2?.3?.4?.5?.11?.25?.34?.39?.41?.42?/?3?務?盡?確?/?務?務?/?務?務?務?/?務?889889?/?497?,?392?,?/?務?盡?盡?盡?副?盡?務?盡?/?4?研?2023?務?889?5?DCT?DCT?/?5?01?/?619192.1%40040045.0%36536541.1%999911.1%6 60.7%?25-44?25-34?35-44?39.5%?39.1%?/?

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3、14336.5%434311.0%656516.6%666616.8%757519.1%?盡?盡?500?5001,000?1,0005,000?5,00010,000?10,000?14414436.7%747418.9%1 10.3%4 41.0%16916943.1%?盡?盡?/?8?59.9%?IT?研?/?務?務?盡?務?32.4%?22.4%?CRC?副?6.6%?/?務?務?DCT?23523559.9%545413.8%28287.1%26266.6%14143.6%13133.3%13133.3%4 1.0%2 0.5%2 20.5%1 10.3%?盡?盡?IT?數據管理統計

4、臨床藥理藥物警戒采購財務868621.9%26266.6%17174.3%9 92.3%888822.4%12712732.4%13133.3%26266.6%?盡?盡?CRACRC?經理軟件工程師高層管理人員(副總裁及以上)?/?9?/?研?94.8%?3.6%?0.8%?0.2%?0.4%?研?研?/?務?務?務?/?9.3%?7.8%?副?/?務?務?47247295.0%18183.6%1 10.2%4 40.8%2 20.4%?/?/?10?46.1%?42.4%?9.9%?1.6%?/?務?副?DCT?DCT?22922946.1%49499.9%21121142.5%8 81.6

5、%?/?11?02?/?12?DCT?/?(?2013?-?)?DCT?,?,?/?務?歲?DCT?28.8%?DCT?導?2013?映?/?務?務?CRO?52.4%?25625628.8%63363371.2%?歲?歲?DCTDCT?969619.3%40140180.7%?歲333322.3%11511577.7%?808047.6%888852.4%CROCRO?/?13?DCTDCT?DCT?/?DCT?,?(eCOA)?研?(eConsent)?務?16.7%?14.4%?12.1%?11.2%?9.8%?去?務?DCT?研?(eCOA)?(eConsent)?/?14?DCT 務

6、?(eCOA)?19.5%?13.6%?DTP?11.9%?(eConsent)?10.2%?研?10.2%)?6.8%?1.7%?CROs?DCT?務?eCOA?(eConsent)?DCT?/?/?15?研?/?務?嫻?52.3%?模?務?務?映?/?務?副?47.6%?模?務?19.9%?32.4%?:?100%?19.919.919.9%32.432.432.4%47.647.647.6%模?/?16?3?DCT?(2024-2026)?DCT?務?務?DCT?確?研?CRO?DCT?/?務?DCT?務?59.6%?35.2%?DCT?務?5.2%?歲?DCT?確?務?24.9%?DC

7、T?務?33.1%?CRO?57.1%?31331335.2%46465.2%53053059.6%?DCTDCT?12412424.9%28285.6%34534569.4%?494933.1%11117.4%888859.5%?969657.1%2 21.2%707041.7%CROCRO?/?17?CROCRO?嗎?/?CRO?DCT?(?DCT)?DCT?/?;?DCT?;?1=?2=?3=?DCT?/CRO?嫻?務?嫻?研?研?研?/?18?嫻?CRA/?20.1%?/?19?DCT?務?0-10?0?10?/?20?DCT?歲?24.9%?19.7%?49.9%?歲?5.5%?務?

8、20.9%?務?25%?CRO 務?31%?務?29.1%?務?17.1%?務?研?研?歲?導?,?,?歲?研?歲?歲?373725.0%434329.1%7 74.7%616141.2%?525231.0%363621.4%7 74.2%737343.5%CROCRO22122124.9%17517519.7%49495.5%44444449.9%?10410420.9%858517.1%29295.8%27927956.1%?不確定?/?21?研?歲?DCT?Phase IV/PMS?務?25.9%?DCT?RWS?務?DCT?15.3%?Phase III?16.2%?DCT?,?(II

9、T)?Phase II?Phase I?務?DCT?14%?10.5%?7.8%?9.7%?歲?DCT?0.7%?研?DCT?研?研?DCT?PhaseIV/PMS?RWS?DCT?Phase I?導?DCT?務?尊?/?22?研?DCT?DCT?11.8%?/去?10%?務?7.7%?DCTDCT?DCT?1.8%?1.9%?DCT?群?DCT?4%?6%?/?23?CRO?/去?務?),?DCT?.CROCRO?DCT?研?DCT?/去?務?DCT?務?DCT?/?2455155161.8%31131134.9%30303.4%?DCT?DCT?27227253.2%30305.9%209

10、20940.9%?研?DCT?的?62%?DCT?DCT?的?CRO?務CRO?72.6%?導?CRO?DCT?DCT?DCT?CRO?DCT?務?的?,?10610671.6%373725.0%5 53.4%?12712772.6%434324.6%5 52.9%CROCRO?/?25?03?/?26?研?(eConsent)?(ePay)?eConsenteConsent?DCT?0-10?模?DCT 務?(eConsent)?(ePay)?eConsent?FDA?ePay?(eConsent)?5?(4.81),?/?(4.79),?研?(4.75),?/?(4.81),?FDA 21

11、 CFR Part11?(4.83)?ePay?5?(5.23),?/?(5.13),?研?(5.14),?(5.15),?(5.21)?/?27?研?(5.38),?/CROSOP?模?(5.38),?的?(5.30),?Wi-Fi?研?(5.35),?(5.25)?5?研?的?DCT 務?,?DCT務?務?(5.36)?(5.31)?的?(5.37)?(5.35)?(5.34)?5?/?28?研?DCT 務?(eCOA)?/?務?研?(5.50)?(5.39)?/?(5.45)?模?(5.50)?/?(5.56)?5?eCOAeCOA?/?DCT 務?研?對?模?/?/?對?研?研?DCT

12、?/?5.35?5.22?研?5.33?研?5.26?5.50?5?/?29?12?務?DCT?務?3?eCOA;?,?研?26.9%?25.4%?;?25.3%?研?22.2%?12?DCT?3?DCTDCT?/?30?研?eCOA?18.7%?DCT?15.8%?研?10.9%?13?DCT?eCOA(12.4%)?12.4%?研?10.1%?13?1 1-3 3?DCTDCT?DCT?;?夠?1-3?DCT?/?31?CRO?eCOA?20.6%?18.1%?11.7%?13?eCOA(13.7%)?12.8%?(9.8%)?研?9.4%?研?EDC?(8.5%?研?7%?1 1-3 3

13、?DCTDCT?研?DCT?50%?eCOA(22%)?15%?DTP(12%)?13?13.5%?eCOA(12.6%)?研?9.9%?研?EDC?(8.5%)?/?32?歲?(55.7%?)?盡?6.6%?CROs?12?54.2%?12?26426429.7%13013014.6%49549555.7%?12?12?939318.7%868617.3%31831864.0%?353523.6%343423.0%797953.4%?919154.5%5 53.0%717142.5%CROCRO?/?33?研?36.2%?33233236.9%14214215.8%42542547.3%?1

14、5815831.8%606012.1%27927956.1%?555537.2%353523.6%585839.2%?767645.2%303017.9%626236.9%CROCRO?/?34?04?/?35?務?16.7%?DCT?32.8%?50.5%?8.8%?65.5%?25.7%?CRO 務?13.1%?45.2%?41.7%?DCT?DCT?務?嫻?DCT?DCT?研?DCT?務 39.9%?歲?15.9%?44.2%?14114115.9%35535539.9%39339344.2%?DCT?DCT?838316.7%16316332.8%25125150.5%?13138.8

15、%979765.5%383825.7%?222213.1%767645.2%707041.7%CROCRO?/?36?研?模?映?DCT?51.9%?17.7%?歲?30.5%?務?56.7%?模?DCT?10.5%?歲?32.8%?52.0%?模?DCT?23.6%?歲?24.3%?CRO 務?39.3%?模?DCT?33.3%?歲?27.4%?模?DCT?尊?導?模?DCT?17.7%?歲?,CDE?:?務?務?務?-?研?,?28228256.7%525210.5%16316332.8%?46146151.9%15715717.7%27127130.5%?DCTDCT777752.0%3

16、53523.6%363624.3%?666639.3%565633.3%464627.4%CROCRO?/?37?DCT?模?DCT?務?DCT?模?導?DCT?模?DCT?務?模?DCT?模?DCT?研?65.9%?DCT?模?3.3%?歲?30.8%?務?59.4%?DCT?模?3.0%?歲?37.6%?76.4%?DCT?模?5.4%?歲?18.2%?CRO 務?76.2%?DCT?模?3.0%?歲?20.8%?58658665.9%29293.3%27427430.8%?DCT?DCT?29529559.4%15153.0%18718737.6%?11311376.4%8 85.4%2

17、72718.2%?12812876.2%5 53.0%353520.8%CROCRO?/?38?(eConsent)?69.1%?(eCOA)/?(ePro)/?(eDiary)?63.9%?65.2%?務?0.2%?5.3%?DCTDCT?DCT?/?DCT?(eConsent)?(eCOA)?(ePro)?(eDiary)?尊?/?39?05?/?40?/?:?/?務?務?研?DCT?/?CRO?確?DCT?嫻?嫻?DCT?eCOA?eConsent?務?DCT?DCT?嫻?確?DCT?務?務?DCT?DCT?模?模?務?/?務?嫻?模?務?DCT?務?/?務?DCT?尊?務?務?務?務?

18、/?41?de Jong,AJ.,van Rijssel,TI.,Zuidgeest,MGP.,van Thiel,GJMW.,Askin,S.,Fons-Martnez,J.,De Smedt,T.,de Boer,A.,Santa-Ana-Tellez,Y.,Gardarsdottir,H.(2022),“Opportunities and Challenges for Decentralized Clinical Trials:European Regulators Perspective.”Clin PharmacolTher,Vol.112 No.2,pp.344-352.Hole,

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20、May,2023).van Rijssel,TI.,de Jong,AJ.,Santa-Ana-Tellez,Y.,Boeckhout,M.,Zuidgeest,MGP.,van Thiel,GJMW.(2022).“Ethics review of decentralized clinical trials(DCTs):Results of a mock ethics review.”Drug Discovery Today.,Vol.27 No.10:103326Martin Boeckhout,Mira G.P.Zuidgeest,Ghislaine J.M.W.van Thiel.(2

21、022),“Ethics review of decentralized clinical trials(DCTs):Results of a mock ethics review”,Drug Discovery Today,Vol.27 No.10.US Food and Drug Administration.(2023),“Decentralized Clinical Trials for Drugs,Biological Products,and Devices Guidance for Industry,Investigators,and Other Stakeholders”,av

22、ailable at:Decentralized Clinical Trials for Drugs,Biological Products,and Devices Draft Guidance for Industry,Investigators,and Other Stakeholders(fda.gov)(accessed May,2023).Vayena E,Blasimme A,Sugarman J.(2023),“Decentralised clinical trials:ethical opportunities and challenges”,Health Policy,Vol.5 No.6,pp.390-394.?/?42?J?務?2020?39?6?321-328.?,?,?確?務?2020?11?102-109?確?務?2020?11?110-116.?務?務?2020?11?117-124.?/?43?/?CRO/SMOCRO/SMO?