Kev sim tshuaj ntsuam xyuas yog qhov tseem ceeb ua lub hauv paus ntawm kev tsim cov tshuaj muaj kev nyab xeeb thiab zoo, tab sis lawv tuaj yeem ua qeeb thiab kim. Tus neeg mob lub nra kuj tuaj yeem siab - lub sijhawm coj mus rau qhov chaw yuav ntev (txog li 70% ntawm cov neeg mob tuaj yeem nyob ntev li ob lossis ntau teev ntawm qhov chaw kho mob), thiab qhov no tuaj yeem ua rau tsis zoo thaum cov chaw tsis muaj. nyob ze cov kev thauj mus los rau pej xeem. Lub sijhawm mus ncig, suav nrog lub sijhawm siv hauv tsev kho mob mus ntsib, tuaj yeem ua rau tsis tuaj yeem ua haujlwm lossis tsev kawm ntawv, lossis teeb meem nrog kev saib xyuas. Muaj cov teeb meem uas cuam tshuam rau kev nkag mus rau kev kawm rau cov neeg laus, cov neeg muaj ntshav siab, cov neeg los ntawm LGBTQIA + cov zej zog thiab cov neeg los ntawm cov haiv neeg tsawg. Tag nrho cov no tuaj yeem cuam tshuam rau kev nrhiav neeg ua haujlwm thiab khaws cia. [1-5]
Ib qho kev daws teeb meem rau qhov no tuaj yeem yog qhov kev sim tshuaj virtual, tseem hu ua tej thaj chaw deb, digital, decentralized lossis siteless sim. Cov no muaj peev xwm ua kom cov txheej txheem kev txhim kho tshuaj muaj txiaj ntsig zoo, suav nrog ntau tus neeg mob-centric, nrog rau kev nthuav dav thaj chaw los ntawm cov neeg mob tuaj yeem xaiv. [5, 6]
Kev sim tshuaj virtual yog ua nyob deb, nrog cov ntaub ntawv sau los ntawm tus neeg mob nyob qhov twg los xij, tsis yog ntawm qhov chaw kuaj mob tshwj xeeb. Cov ntaub ntawv yog amassed nyob rau hauv ntau txoj kev, nrog rau telemedicine platforms, thiab wearable pab kiag li lawm thiab sensors. [1]
Cov txiaj ntsig ntawm kev sim tshuaj virtual
Kev sim tshuaj virtual tuaj yeem sau cov ntaub ntawv ntawm txhua qhov chaw xaiv. Qhov no tuaj yeem txhim kho kev nrhiav neeg ua haujlwm thiab kev tuav pov hwm los ntawm kev txo lub nra ntawm kev mus ncig rau cov neeg mob, tshwj xeeb tshaj yog rau cov neeg laus, cov neeg muaj teeb meem kev txav mus los thiab cov neeg nyob hauv ib qho chaw nyob deb nroog, thiab zam lub sijhawm poob ntawm kev ua haujlwm lossis kev kawm. Tsis tas yuav tsum taug kev deb ntawm tsev tuaj yeem pab cov neeg muaj ntshav qab zib, cov neeg los ntawm LGBTQIA + zej zog uas ntshai kev ntxub ntxaug, thiab cov neeg uas xav tias lawv haiv neeg, kab lis kev cai lossis kev ntseeg cais lawv los ntawm kev kawm. [2, 3, 7]
Los ntawm kev tshem tawm cov teeb meem nkag, virtualkho mobkev sim tuaj yeem tso cai rau cov kws tshawb fawb nkag mus rau cov pej xeem dav thiab ntau haiv neeg. Qhov no tsim cov ntaub ntawv nplua nuj thiab muaj zog dua cov ntaub ntawv uas muaj ze ze rau cov pej xeem uas yuav tau txais cov tshuaj thaum nws mus txog lub khw. [6, 8]
Kev sim tshuaj virtual tuaj yeem txo cov nqi rau cov neeg txhawb nqa, los ntawm kev tshem tawm qhov xav tau ntawm kev them nyiaj rov qab ntawm cov neeg koom nrog cov nqi mus ncig, txiav qhov chaw thiab cov neeg ua haujlwm cov nqi, ua kom cov npe nkag thiab ua kom ceev cov ntaub ntawv khaws cia. Los ntawm kev txhim kho kev nrhiav neeg ua haujlwm thiab khaws cia, lawv kuj txo qhov kev pheej hmoo uas yuav tsum tau rov ua dua vim tias tsis muaj cov neeg koom nrog. [6]
Cov teeb meem ntawm kev sim tshuaj virtual
Txawm li cas los xij, muaj kev nyuaj rau kev sim virtual, tab sis nrog kev npaj lawv tuaj yeem kov yeej. Kev sim tshuaj virtual uas xav kom cov neeg mob siv thev naus laus zis lossis kev siv internet yuav txwv tsis pub cov neeg nyob hauv thaj chaw deb nrog cov teeb liab tsis zoo, tsis muaj cov khoom siv txawb xws li smartphones lossis ntsiav tshuaj, lossis cov neeg uas muaj kev paub siv thev naus laus zis tsawg. Cov kev faib digital tuaj yeem txuas nrog los ntawm kev muab cov khoom siv thiab kev pabcuam hauv internet, ncaj qha rau cov neeg mob lossis los ntawm kev koom tes nrog cov chaw hauv zej zog lossis cov tsev qiv ntawv hauv zos. Tus neeg txhawb nqa kev sim tuaj yeem muab cov neeg koom nrog sim nrog kev kawm thiab kev cob qhia, thiab xyuas kom cov neeg koom tuaj yeem nkag mus rau cov pab pawg los muab kev txhawb nqa ntxiv. [7, 8]
Muaj cov ntaub ntawv nyuaj uas cuam tshuam nrog kev sim tshuaj virtual, thiab cov koom haum nkag mus rau thaj chaw no yuav tsum paub txog cov no thiab xyuas kom lawv tau txais kev cob qhia cov neeg ua haujlwm tsim nyog lossis cov kws pab tswv yim sab nraud. Kev sim tshuaj virtual tsim cov ntaub ntawv hauv ntau qhov loj, thiab qhov no yuav tsum muaj kev txawj ntse hauv cov ntaub ntawv tuav thiab tshuaj xyuas, nrog rau kev tsim cov ntaub ntawv thoob plaws hauv cov platforms thiab cov khoom siv. [6]
Cov ntaub ntawv zoo tsis tuaj yeem tswj tau zoo ib yam li nyob rau hauv qhov chaw kuaj mob - piv txwv li, tus neeg mob yuav tsis hnav lub cuab yeej kom raug, lossis cov ntaub ntawv muab yuav cuam tshuam rau kev them nyiaj lossis yog tias nws yuav tsum tau muab tshem tawm rau da dej lossis da dej. Cov neeg mob kuj tuaj yeem tsis nco qab xa cov ntaub ntawv hais txog kev noj lwm yam tshuaj. [6, 7] Qhov no yuav tsum tau coj mus rau hauv tus account hauv kev txheeb xyuas cov ntaub ntawv.
Cov ntaub ntawv los ntawm kev sim tshuaj ntsuam xyuas yog qhov tseem ceeb heev, ob qho tib si los ntawm kev lag luam thiab kev coj ncaj ncees. Cov tuam txhab uas siv cov kev sim tshuaj virtual yuav tsum xyuas kom meej tias cov ntaub ntawv tsis qhia npe, thiab cov kev tshawb xyuas kev ruaj ntseg tsis tu ncua tau ua. Kev cob qhia cov neeg mob txog cov ntaub ntawv ntiag tug thiab siv lawv cov ntaub ntawv li cas yuav pab tsim kev ntseeg siab. [8]
Qhov tsis muaj kev sib tham tim ntsej tim muag thiab qhov yuav tsum tau nkag mus rau cov ntaub ntawv los yog hnav cov sensors tuaj yeem ua rau cov kev sim tshuaj virtual nyuaj rau cov neeg koom. Cov koom haum uas khiav qhov kev sim siab yuav tsum tau paub txog kev qaug zog digital thiab ua haujlwm kom muaj kev koom tes. [6]
Vim tias qhov kev sim tshuaj virtual tseem yog qhov tshiab, qee qhov kev tswj hwm cov cai yuav tsis kam lees txais cov ntaub ntawv los ntawm cov ntsiab lus tsis tshua muaj qhov kawg lossis qhov chaw. Qhov no hloov, txawm li cas los xij; Piv txwv li, thaum Lub Kaum Ob Hlis 2023, US Food and Drug Administration (FDA) tau tshaj tawm cov lus qhia txog kev noj qab haus huv cov thev naus laus zis rau kev nrhiav cov ntaub ntawv nyob deb rau kev lag luam thiab cov neeg tshawb xyuas. [9] Cov tuam txhab tuaj yeem pab cov txheej txheem los ntawm kev tsom mus rau cov lus qhia thiab kev coj ua zoo tshaj plaws. Ua haujlwm ze nrog cov thawj coj tswj hwm tsis yog tsuas yog pab cov tuam txhab kom taug qab, nws tseem tso cai rau lawv los pab txhim kho kev txhim kho yav tom ntej ntawm cov txheej txheem. [8]
Wearable devices thiab sensors
Wearable devices tso cai rau cov kws tshawb fawb los sau cov ntaub ntawv ntev dua yam tsis muaj cov neeg mob tau mus koom qhov chaw sim tshuaj. Cov yam ntxwv uas tuaj yeem ntsuas tau suav nrog lub plawv dhia, qauv pw tsaug zog, ua pa, ntsuas kub, qib oxygen, ntshav siab, ntshav qabzib, thiab qib kev ua haujlwm. Lawv kuj tuaj yeem ntsuas kev ua haujlwm tshwj xeebkho mobkev sim, piv txwv li cov neeg mob khawb hauv lawv txoj kev pw tsaug zog hauv kev tshawb fawb eczema. [7, 8, 10]
Wearables, txawm li cas los xij, khiav txoj kev pheej hmoo ntawm kev siv los ntawm lwm tus neeg uas tsis yog cov neeg koom nrog kev sim, tab sis cov kws tshawb fawb tuaj yeem tau txais qhov no los ntawm kev xav tau cov ntaub ntawv tsis tu ncua, lossis txheeb xyuas cov neeg siv los ntawm cov yam ntxwv biometric. [7]
Telemedicine platforms
Tus kab mob COVID-19 kis thoob qhov txhia chaw ua rau muaj kev nthuav dav dav ntawm kev kho mob, uas siv cov ntaub ntawv hluav taws xob thiab kev sib txuas lus thev naus laus zis los txhawb kev noj qab haus huv sab nraud ntawm chaw kho mob lossis tsev kho mob. Telemedicine platforms tso cai rau cov neeg ua haujlwm sim tshuaj xyuas nrog cov neeg mob thiab ua cov kev ntsuam xyuas nyob deb, piv txwv li tag nrho cov tsos mob, qhov ua tsis taus pa, kev txawj ntse thiab kev hloov ntawm daim tawv nqaij. [11, 12]
Kev sim hybrid
Qee qhov kev sim yuav nyuaj dhau rau qhov kev sim virtual, thiab tej zaum yuav xav tau mus ntsib kws kho mob tsis tu ncua. Nws tseem tuaj yeem ua rau qee qhov ntawm txoj kev tshawb fawb virtual, txhawm rau txo lub nra ntawm cov neeg mob thaum tswj kev sib raug zoo nrog qhov chaw sim. [8]
Txawm hais tias kev sim tshuaj virtual muaj cov kev sib tw, cov no tuaj yeem dhau los ntawm lawv cov txiaj ntsig: tus nqi qis dua, tau txais txiaj ntsig sai dua thiab kev nrhiav neeg ua haujlwm yooj yim dua, nrog rau kev yooj yim dua rau cov neeg mob. Lawv yuav txuas ntxiv txhim kho thiab hloov pauv thiab yuav pab cov tuam txhab coj cov kev kho tshiab rau cov neeg mob sai dua thaum ua kom muaj kev nyab xeeb.
Cov ntaub ntawv
1. National Academies of Sciences, Engineering and Medicine, Health and Medicine Division, Board on Health Sciences Policy, and Forum on Drug Discovery, Development and Translation, Virtual Clinical Trials: Challenges and Opportunities: Proceedings of a Rhiav, ed. C. Shore, E. Khandekar, thiab J. Alper. 2019, Washington (DC).
2. Elvidge, S., Queering kev tshawb fawb soj ntsuam. Lub Peakwords blog: Sau txog kev tshawb fawb, 27 Lub Peb Hlis 2024. Muaj los ntawm: https://www.peakwords.com/the-blog-writing-about-science/queering-clinical-research.
3. Elvidge, S., Yog vim li cas muaj ntau haiv neeg sawv cev nyob rau hauv kev soj ntsuam cov teeb meem. Pharma Sources: Ib qhov muag ntawm kev lag luam biopharma, 19 Lub Peb Hlis 2024. Muaj los ntawm: https://www.pharmasources.com/industryinsights/why-diverse-representation-in-clinical-r-76347.html.
4. Adams, B., Sanofi launches tshiab virtual trials offer with Science 37. Fierce Biotech, 2 March 2017. Muaj los ntawm: https://www.fiercebiotech.com/cro/sanofi-launches-new-virtual-trials-offering -science-37.
5. Ranganathan, P., R. Aggarwal, thiab CS Pramesh, Virtual kev sim tshuaj. Perspect Clin Re, 2023. 14(4): p. 203-206.
6. Pab Pawg Kws Tshawb Fawb Txog Kev Tshawb Fawb, Txhua Yam Koj Yuav Tsum Paub Txog Virtual Clinical Trials. Quanticate blog, 12 Plaub Hlis 2024. Muaj los ntawm: https://www.quanticate.com/blog/virtual-trials.
7. Mittermaier, M., KP Venkatesh, thiab JC Kvedar, Digital health technology hauv kev sim tshuaj. NPJ Digit Med, 2023. 6(1): p. 88.
8. Cov neeg ua haujlwm sau ntawv, Yuav ua li cas Virtual Clinical Trials yog Revolutionizing Health Research. ObvioHealth blog, 13 Lub Xya Hli 2023. Muaj los ntawm: https://www.obviohealth.com/resources/how-virtual-clinical-trials-are-revolutionizing-health-research.
9. FDA, Digital Health technologies for remote Data Acquisition in Clinical Investigations: Kev taw qhia rau kev lag luam, cov neeg soj ntsuam, thiab lwm yam muaj feem xyuam. US Department of Health thiab Human Services; Food and Drug Administration; Center for Drug Evaluation and Research (CDER); Center for Biologics Evaluation and Research (CBER); Center for Devices and Radiological Health (CDRH); Oncology Center of Excellence (OCE). 2023. Muaj los ntawm: https://www.fda.gov/media/155022/download.
10. Ilancheran, M., Kev siv Wearable Thiab Sensor Applications hauv kev sim tshuaj yog Booming. Tus Thawj Saib Xyuas Kev Kho Mob, 26 Lub Kaum Hli 2021. Muaj los ntawm: https://www.clinicalleader.com/doc/use-of-wearable-and-sensor-applications-in-clinical-trials-is-booming{13}}.
11. Chiang, A. thiab RS Herbst, Yuav Ua Li Cas Telemedicine tuaj yeem hloov kho kev tshawb fawb thiab kev xyaum. ASCO Post, 25 Kaum Ob Hlis 2022. Muaj los ntawm: https://ascopost.com/issues/december-25-2022/how-telemedicine-can-transform-clinical-research-and-practice/.
12. Lub Tsev Haujlwm Saib Xyuas Tshuaj (Tebchaws Asmeskas) Pawg Saib Xyuas Kev Ntsuam Xyuas Kev Siv Tshuaj Kho Mob ntawm Telemedicine, Telemedicine: Phau Ntawv Qhia Txog Kev Ntsuas Kev Sib Txuas Lus hauv Kev Kho Mob, ed. MJ Field. Xyoo 1996, Washington (DC).
Txog Tus Sau:
Suzanne Elvidge: koj puas xav tau ntau tus thwjtim?
Raws li nyob rau sab qaum teb ntawm Askiv, Suzanne Elvidge yog tus kws sau ntawv kho mob ywj pheej nrog 30- xyoo dhau los hauv kev sau xov xwm, sau ntawv, tshaj tawm, kev sib txuas lus thiab PR. Nws tau sau cov yam ntxwv thiab cov xov xwm rau ntau yam kev tshaj tawm, suav nrog BioPharma Dive, Pharmaceutical Journal, Nature Biotechnology, Nature BioPharma Dealmakers, Nature InsideView thiab lwm yam Nature tshaj tawm, rau npe rau ob peb tug. Nws kuj tau sau cov lus qhia tob thiab ebooks ntawm ntau yam kev lag luam thiab kab mob rau FirstWord, PharmaSources, thiab FierceMarkets. Suzanne tau los ua ib tus neeg ua haujlwm ywj pheej hauv xyoo 2006, thiab nws sau txog cov tshuaj, kev kho mob thiab tshuaj, thiab kev kho mob, tshuaj thiab biotechnology industries, rau kev lag luam, kev tshawb fawb, kev kho mob thiab cov neeg tuaj saib.