Cov txheej txheem:
Video: NCT sawv cev rau dab tsi hauv kev sim tshuaj?
2024 Tus sau: Stanley Ellington | [email protected]. Kawg hloov kho: 2023-12-16 00:17
Yuav Tsum Qhia Txog Lub Tebchaws Kev sim tshuaj ( NCT ) Tus cim.
Tib neeg kuj nug, qhov kev sim tshuaj NCT Number yog dab tsi?
Cov NCT Num , kuj hu ua ClinicalTrials .gov Identifier, raug xa mus tom qab cov ntaub ntawv raws tu qauv tau tso tawm (xa tawm) los ntawm Pawg Neeg Saib Xyuas Lub Luag Haujlwm thiab dhau los tshuaj xyuas los ntawm ClinicalTrials .gov cov neeg ua haujlwm. Saib Yuav Ua Li Cas Sau Npe Koj Txoj Kev Kawm yog xav paub ntxiv.
Tsis tas li ntawd, 4 theem ntawm kev sim tshuaj yog dab tsi? Ntsiab lus
| Cov ntsiab lus ntawm cov theem kev sim tshuaj | |
|---|---|
| Theem | Lub hom phiaj tseem ceeb |
| Theem 0 | Pharmacokinetics; tshwj xeeb, qhov ncauj bioavailability thiab ib nrab-lub neej ntawm cov tshuaj |
| Phase I | Kev sim tshuaj ntawm cov neeg ua haujlwm noj qab haus huv rau kev nyab xeeb; suav nrog kev sim ntau koob tshuaj (dose-ranging) |
| Phase II | Kev sim tshuaj ntawm cov neeg mob los ntsuas kev ua tau zoo thiab cov kev mob tshwm sim |
Yog li ntawd, dab tsi yog txhais los ntawm kev sim tshuaj?
Kev sim tshuaj yog cov kev tshawb fawb tshawb fawb uas cov neeg tuaj yeem tuaj yeem kuaj cov kev kho tshiab, kev cuam tshuam lossis kev sim ua ib qho txhais tau tias tiv thaiv, ntes, kho lossis tswj ntau yam kab mob lossis kev kho mob. Qee qhov kev tshawb nrhiav saib seb tib neeg teb li cas rau qhov kev cuam tshuam tshiab * thiab cov kev mob tshwm sim yuav tshwm sim li cas.
Dab tsi yog qhov txawv ntawm kev sim tshuaj?
Muaj ob hom kev kuaj mob tseem ceeb - kev soj ntsuam thiab kev cuam tshuam:
- Kev soj ntsuam soj ntsuam tsis kuaj tshuaj lossis kev kho mob.
- Interventional kev sim tshuaj ntsuam xyuas kev nyab xeeb thiab kev ua tau zoo ntawm tus neeg sib tw tshuaj, kev kho lossis kev sim kev kho mob.
Pom zoo:
Lub sijhawm tam sim no sawv cev dab tsi hauv Alcoa txoj cai?
Contemporaneous txhais tau tias sau cov txiaj ntsig, ntsuas lossis cov ntaub ntawv thaum lub sijhawm ua haujlwm. Hnub tim thiab sijhawm cov ntawv yuav tsum ntws kom ua tiav rau cov ntaub ntawv kom ntseeg tau. Cov ntaub ntawv uas tau nkag mus, lossis ntsuas uas tau ua hauv tshuab hluav taws xob, yuav tsum muaj hnub tim/sijhawm thwj cim txuas nrog cov ntaub ntawv
Kev saib xyuas kev kho mob hauv kev sim tshuaj yog dab tsi?
Kev Saib Xyuas Kev Kho Mob, Kev Txheeb Xyuas Kev Kho Mob muab kev paub txog kev kho mob thiab saib xyuas rau tag nrho cov kev sim tshuaj, los ntawm kev tshawb fawb thawj zaug los ntawm kev kawm zaum kawg. Kev lees paub thiab muab kev taw qhia rau thaum twg ib qho kev kawm yuav tsum tsis txhob dig muag vim muaj xwm txheej ceev
Thaum kev lag luam nkag mus rau kev lag luam vim kev poob qis hauv kev thov dab tsi yuav tshwm sim rau qib nqi?
A) Thaum kev lag luam nkag mus rau kev lag luam poob qis vim qhov kev thov poob qis, yuav ua li cas rau qib nqi? Cov khoom tso tawm thiab cov nqi nkag ib txwm poob thaum muaj kev lag luam poob qis. Tus nqi nce nqi nce thaum lub sij hawm boom thiab ntog thaum lub sij hawm kev lag luam, nws ib txwm tsis mus qis dua xoom vim tias cov nyiaj tau nce tsis tu ncua
Tus neeg twg tau soj ntsuam kev mloog lus ntawm kev sib raug zoo los ntawm kev ua ib qho kev sim uas yuav tsum muaj cov tub ntxhais kawm cov ntsiab lus los tswj cov kev mob siab rau cov ntsiab lus hauv kev tshuaj xyuas kev kawm?
Milgram Shock Experiment Ib qho ntawm cov kev tshawb fawb nto moo tshaj plaws ntawm kev mloog lus hauv kev puas siab puas ntsws tau ua los ntawm Stanley Milgram, tus kws kho mob hlwb ntawm Yale University. Nws tau ua ib qho kev sim qhia txog qhov tsis sib haum xeeb ntawm kev mloog lus rau txoj cai thiab lub siab ntawm tus kheej
CFR sawv cev rau dab tsi hauv kev sim tshuaj?
CRO tuaj yeem pab saib xyuas, tshuaj xyuas, kev tswj xyuas qhov project thiab lwm yam, pab kom ua raws li kev soj ntsuam thiab ua raws li kev sim tshuaj. CFR - Code of Federal Regulations - Txoj Cai Federal Regulations (CFR) yog ib txheej ntawm cov kev cai luam tawm los ntawm tsoomfwv cov koomhaum, suav nrog FDA