I doctor hian nangmah emaw, i chhungte zinga mi emaw hnenah ‘clinical trial’, medical research project thar chungchang a hrilh tawh em? Chutiang thil a thlen chuan hlauhna leh hriat duhna tlem a awm chu thil pangngai a ni. "Hei hian ka thatna a thlen dawn em ni? Harsatna a thlen dawn em ni?" Zawhna tam tak ka rilruah a lo lang ngei ang. Miten he thu hi an hriat hian "mei vawk" anga hman an ni tih an ngaihtuah thin. Mahse chutiang chu a ni tak tak lo. Chuvangin vawiin hian clinical trial chu eng nge a nih a, eng nge a ken tel tih hi awlsam tak leh chiang takin sawi ila.
A awlsam zawngin, clinical trial chu eng nge ni?
A awlsam zawngin, hei hi scientist leh doctor team pakhatin damdawi thar, enkawlna thar, damdawi hmanraw thar, a nih loh leh natna hriat theih dan thar chu mi pawl pakhat chunga enchhin a, a hlawkzia leh a himzia hriat theihna tura an inkhawm hi a ni. A tum ber chu enkawlna awmsa aiin enkawlna hmasawn zawk, hlawk zawk leh him zawk zawng chhuah hi a ni.
Ngaihtuah teh, natna khirh tak tak ṭhenkhat chu tuna enkawlna pangngai hmang hian tihdam theih a ni lo mai thei. Chutiang hunah chuan hetiang zirchianna thar hi i tan a tangkai hle thei a ni.
Heng enkawlna tharte hi vawi khatah mi hnenah pek vek a ni lo.
1. Pakhatnaah chuan hengte hi laboratory-ah uluk takin test an nei thin.
2. Tichuan, rannung hmangin experiment an nei leh thin.
3. Heng a hmasa pahnihah hian enkawlna hi a him a, a hlawk tih finfiah a nih chauhvin mihring enchhin a tan ang. Mahse, a hmasain pawl tenau hnenah pek a ni ang a, chumi hnuah pawl lian zawkte hnenah pek a ni ang.
He zirchianna hmang hian doctor-te chuan zawhna chhanna an zawng mek a ni:
- He enkawlna hi a him em? A hlawk em?
- Hei hian engtiang chiahin nge rah tha a chhuah ang?
- Tuna enkawlna aiin hei hi a tha zawk em?
- He enkawlna hian eng side effect leh risk nge a neih?
He zirchianna hi eng phase nge awm?
Clinical trial-ah hian main stage, a nih loh leh "phase" engemaw zat a awm a. Phase khata information hmuh chu phase dang a information hmuh atanga siam a ni. I hriselna dinhmun emaw, i natna nasat dan emaw a zirin phase bik atan thlan theih i ni. A tlangpuiin damlo tam zawk hi Phase III emaw IV emaw-ah an tel thin.
| Hunbi | Hetah hian eng thil nge thleng? |
|---|---|
| Phase I ah hian a awm | Doctor-te chuan enkawlna thar hi mi tlemte (mi hrisel volunteer emaw damlo emaw) chungah an test a, a himzia an hriat theih nan . Dose him, damdawi pek dan tha ber leh eng side effect nge a neih theih tih te an zawng thin. |
| Phase II-na a ni | Hetah hian zirchiangtute chuan he enkawlna hian natna bik pakhat tan engtiang chiahin nge a thawh that tih an en a. Hei hian a hmasa ber aiin mipui pawl lian zawk a huam a ni. |
| Phase III-na a ni | Hei hian enkawlna thar leh tuna hman mek standard treatment tehkhin a huam a ni. Tin, population hrang hrang (e.g. mipa, hmeichhia, thalai, kum upa lam) leh dose hrang hranga enkawlna hnathawh dan a en bawk. He phase-ah hian damlo pawl lian tak an tel a ni. |
| Phase IV ah hian a awm | He phase-ah hian enkawlna pawm a nih hnuah pawh market-a tihchhuah a nih hnuah pawh a chungchang information lakkhawm a ni. A tum ber chu hun rei tak chhunga enkawlna hi engtiang chiahin nge a hlawkpui tih leh a hmaa a hmaa hriat loh side effects hmuh tur awm lo a awm em tih hriat a ni. |
Clinical trial-a tel hian eng hlawkna nge a neih?
- Enkawlna thar ber dawn theihna hun remchang: Mipui zahawmte tana hman theih a nih hmain enkawlna thar ber ber, hmasawn ber dawng theihna hun remchang i nei thei a ni.
- Nakin hun atâna ṭanpuina: I thu hriatte hian zirchiangtute chu nakin lawka damlo dang sâng tam takte ṭanpui thei tûr enkawlna ṭha zâwk siam tûrin nasa takin a ṭanpui ang.
- Cost tihtlem: Research nena inzawm test leh doctor tlawhna senso tam tak hi research sponsor tu pawlin a tum tlangpui. Mahse, zirchiannaa i tel hmain i medical team nen chiang taka sawiho a pawimawh.
Hetiang zirchianna hian harsatna a thlen thei em?
Ni e, enkawlna dang ang bawkin, hlauhawmna engemaw zat a awm. A hlauhawmna zau zawng chu enkawlna chi hrang hrang leh i hriselna tlangpuiah a innghat a ni.
A bulpui ber chu heng enkawlnate hi research stage-a an la awm avangin scientist-te chuan i taksa a nghawng dan tur an hre chiang lo. Chuvangin, enkawlna din tawh aiin side effect hriat loh a awm theihna a sang zawk thei.
Informed Consent tih hi eng nge ni?
Hei hi clinical trial-a thil pawimawh ber a ni. Research-a i tel hmain doctor leh nurse-te chuan enkawlna chu kimchang takin an hrilhfiah ang che, a hlawkna leh hlauhawmna awm thei te pawh an hrilhfiah ang che. Zawhna i neih apiang zawh theihna hun remchang an pe ang che.
Heng zawng zawng hi i hriatthiam kim tawh chuan zirchiannaa tel duhna document-ah sign turin an ti ang che. Hetiang kalphung hi "Informed Consent" tih a ni.
Sign up hian he zirchiannaah hian a phuar lo che tih hre reng ang che. Hemi atang hian engtik lai pawhin, eng chhan pawh ni se, inhnukdawk theihna dikna i nei vek a ni.
Tin, he awareness process hi vawi khatah a tawp lo bawk. Research neih chhunga enkawlna chungchanga thu thar a awm chuan, medical team chuan chu thu zawng zawng chu hriattir chhunzawm zel turin an inpeih reng a ni.
Thutlukna i siam hmaa i zawh tur zawhnate
Clinical trial-a tel i ngaihtuah a nih chuan thutlukna i siam hmain i theih ang tawka zir hmasa phawt ang che. I doctor zawh ngei ngei tur zawhna thenkhat chu hetiang hi a ni:
- He damdawi lam zirchianna hian eng nge a tum tak tak ?
- He zirchiannaah hian eng test leh treatment nge telh? Engtin nge pek an nih ang?
- He enkawlna thar hi awm lo se chuan standard treatment hmang hian ka dinhmun hi eng ang nge ni ang? Hei hi tuna enkawlna nen hian engtin nge a khaikhin?
- He zirchianna hian engtin nge ka nitin nun a nghawng ang?
- Eng side effect nge ka beisei theih ang?
- He zirchianna hian eng chen nge a daih ang? Chumi atan chuan hun tam zawk ka hlan a ngai dawn em ni?
- Damdawi inah ka awm a ngai dawn em ni? Chutiang a nih chuan eng chen nge leh eng chen nge?
- Research atanga inhnuhdawh ka tum a nih chuan ka enkawlna a nghawng dawn em? Doctor ka thlak a ngai dawn em ni?
Take-Home Thuchah a ni
- Clinical trial hi scientific study a ni a, tuna enkawlna awm mek aiin enkawlna tha zawk, him zawk leh hlawk zawk zawng chhuah a ni.
- Hei hi phase hrang hrang a awm a. Phase tin thil tum hi a inang lo hle.
- A hlawkna zingah hian enkawlna thar ber ber dawng leh hmalam hun atana tanpui te a tel. Pawh,Side effect hriat loh pawh a awm thei bawk .
- Informed consent hi signature aiin a tam zawk. Hrilhfiahna famkima innghat kalphung a ni.
- Research atang hian engtik lai pawhin i inhnukdawk thei a, engmah a nghawng lo.
- Thutlukna i siam hmain i doctor nen i ngaihtuahna zawng zawng chu zalen takin sawipui hmasa phawt ang che.
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