Yu dɔn ɛva yɛri di wɔd ‘klinikal trial’? Sɔntɛm yu dɔn si am na fim ɔ na nyuspepa. Sɔm pipul dɛn tink se na big tin we de mek pɔsin fred. Bɔt fɔ tru, bɔku pan di mɛrɛsin ɛn tritmɛnt dɛn we wi de yuz tide, na bikɔs dɛn dɔn du risach lɛk dis. If dɛn nɔ bin de, nyu mɛrɛsin dɛn we go sev layf nɔ bin fɔ de. So, tide wi go tɔk bɔt wetin na ‘klinikal trial’, wetin i bi, aw dɛn kin du am, ɛn wetin na di bɛnifit ɛn risk dɛm.
Fɔ tɔk am simpul wan, wetin na klinik trial?
I rili simpul. Klinik trial na mɛdikal risach stɔdi we pipul dɛn we de volontia de du. Dis na di onli we fɔ no if nyu tritmɛnt rili wok ɛn if i sef fɔ pipul dɛn fɔ yuz.
Dis risach kin bi bɔt difrɛn tin dɛn.
- Bɔt wan we fɔ fɛn nyu sik.
- Bɔt wan we fɔ mek yu nɔ sik.
- Bɔt nyu mɛrɛsin, sɔm mɛrɛsin dɛn we dɛn jɔyn togɛda, ɔ nyu mɛrɛsin.
Insay dis atikul, wi go tɔk mɔ bɔt risach bɔt nyu tritmɛnt dɛn. Sɔmtɛm, bikɔs yu gɛt wan sik, yu kin want fɔ put an pan am as we fɔ gɛt nyu tritmɛnt fɔ am. Dɔn bak, pipul dɛn we gɛt wɛlbɔdi ɛn we nɔ sik atɔl kin volontia fɔ ɛp fɔ go bifo pan mɛrɛsin sayɛns ɛn ɛp ɔda pipul dɛn we sik.
Wetin kin apin bifo yu bigin fɔ du risach?
Dɛn nɔ kin ebul fɔ stat wan klinik trial wan tɛm. Wan lɔng prɔses de bifo dat. Tink bɔt am lɛk fɔ du risach bɔt di rod, chɛk di motoka, ɛn rɛdi ɔltin bifo yu go fɔ lɔng tɛm.
- Prɛklinik tɛst: Ɔl di risach kin bigin wit wan aidia. Dat min se, wan aidia lɛk "Dis nyu mɛrɛsin go wok fɔ dis sik." Dɔn dɛn kin tɛst dis drɔg fɔs na di lɛbɔraytri (labɔraytri tɛst) ɛn sɔm tɛm dɛn kin tɛst am pan animal (stɔdi pan animal).
- Klinik trial protɔkɔl: If di fɔs tɛst dɛn sho se di nyu tritmɛnt gɛt chans fɔ gɛt sakrifays, di wan dɛn we de du di risach kin mek wan plan we rili ditayli. Dɛn kɔl dis ``protocol.'' I fɔ tɔk klia wan wetin mek dɛn de du di trayal, us tritmɛnt dɛn de tɛst, ɛn wetin di ``trayal ɛndpɔynt'' dɛn de ɛkspɛkt fɔ mɛzhɔ we di trayal dɔn.
- Fɔ gɛt aprɔval:Ivin na wi kɔntri, lɛk ɛni kɔntri na di wɔl, bifo dɛn du risach we gɛt fɔ du wit pipul dɛn, dɛn fɔ gɛt aprɔval frɔm di wɛlbɔdi ɔtoriti dɛn na da kɔntri de (fɔ ɛgzampul, frɔm institiushɔn dɛn lɛk di Nashɔnal Mɛdisin Rigyulatɔri Ɔtoriti - NMRA na Sri Lanka) ɛn frɔm wan spɛshal ɛtikul kɔmiti (Instityushɔnal Rivyu Bɔd - IRB ɔ Ɛtiks Kɔmiti) na di ɔspitul ɔ institiushɔn we de du di risach. Di men tin we dɛn mek dis kɔmiti na fɔ mek shɔ se di wan dɛn we de tek pat pan di risach sef ɛn gɛt rayt .
Na afta dɛn dɔn gɛt ɔl dis aprɔval, na in di wan dɛn we de du risach kin bigin fɔ luk fɔ pipul dɛn we rɛdi fɔ tek pat.
Wan tin we rili impɔtant: Fɔ Kɔnsɛnt we dɛn no bɔt
If yu de tink bɔt fɔ jɔyn klinik trial, dis na di impɔtant tin we yu fɔ du. I nɔ jɔs bi pepa we yu de sayn. Na ditayl diskushɔn bitwin yu ɛn di risach tim.
Insay dis ``Informed Consent'' prɔses, di risach tim kin ɛksplen ɔltin to yu.
- Wetin na di tin dɛn we dɛn want fɔ du fɔ di risach?
- Us tritmɛnt dɛn de fɔ yu?
- Aw lɔng dis dɔn de apin?
- Wetin na di prɔblɛm ɛn bɛnifit dɛn we yu go gɛt?
- Us ɔda tritmɛnt dɛn de wae yu kin gɛt wae nɔr gɛt natin fɔ du wit dis?
- Yu tink se i go kɔst yu ɛnitin?
- Aw yu kin kip yu pɔsin in infɔmeshɔn kɔnfidɛns?
Dɛn go gi yu wan dɔkyumɛnt we gɛt ɔl dɛn tin ya fɔ rid. I kin kɔmplikt smɔl, so nɔ fred fɔ aks ɛni kwɛstyɔn we yu gɛt, ilɛksɛf i smɔl.
Mɛmba se fɔ tek pat pan dis na fɔ yusɛf ɔltogɛda . Yu gɛt rayt fɔ pul yusɛf kɔmɔt pan dis stɔdi ɛnitɛm, we yu nɔ gi rizin, ilɛksɛf afta yu dɔn sayn ɔ we yu de du di risach.
Sɔm trayal dɛn kin du insay ``randomized`` we. Dis min se dɛn kin disayd am randomly, lɛk fɔ flip kɔyn, if yu gɛt di nyu drɔg ɔ di standad tritmɛnt we de naw. Dis na sɔntin bak we yu fɔ no bifo tɛm.
Faz dɛm fɔ wan Klinik Trayal
Bɔku tɛm, 4 men tin dɛn de we dɛn kin du fɔ du risach bɔt wan nyu mɛrɛsin. Ɛni pat gɛt difrɛn tin we dɛn want fɔ du, ɛn dɛn kin tek nyu volontia dɛn fɔ ɛni pat.
| Tɛm | Nɔmba ɛn di kayn pipul dɛn we tek pat | Di men tin we dɛn want fɔ du |
|---|---|---|
| Faz 1 we de na di wɔl | Wan smɔl grup (lɛk 20-100). Jɛnɛral pipul dɛn we gɛt wɛlbɔdi. | Fɔ mek shɔ se di mɛrɛsin sef , fɔ fɛn di rayt doz, ɛn chɛk fɔ siriɔs sayd ɛfɛkt fɔs. |
| Faz 2 we de na di wɔl | Wan grup we big smɔl (lɛk 100-300) pan pipul dɛm wae gɛt mɛdikal kɔndishɔn wae gɛt fɔ du wit di risach. | Fɔ si if di mɛrɛsin de wok (effectiveness) fɔ di sik we dɛn de tɔk bɔt. I de kɔntinyu bak fɔ wach if nyu sayd ɛfɛkt dɛn de kɔmɔt. |
| Faz 3 we yu go du | Wan rili big grup (300-3,000 ɔr mɔr) fɔ pipul dɛm wae gɛt di rilevɛns mɛdikal kɔndishɔn. | Fɔda kɔnfɔmeshɔn fɔ di drɔg in sef ɛn ɛfifikɛshɔn. Kɔmpia wit di standad tritmɛnt dɛn we de naw. Di rizɔlt fɔ dis pat go sho if dɛn go gri fɔ yuz di mɛrɛsin fɔ ɔlman yuz ɔ nɔ go gri fɔ yuz am. |
| Faz 4 we dɛn kɔl | Afta dɛn dɔn gri fɔ yuz di mɛrɛsin, bɔku bɔku pipul dɛn we sik bin yuz am. | Monitoring fɔ prɔblɛm dɛn we kin apin we dɛn de yuz am fɔ lɔng tɛm, ɛn fɔ rare sayd ɛfɛkt dɛn we dɛn nɔ bin dɔn si bifo, afta di drɔg kam na di makit. |
Wetin na di bɛnifit ɛn risk dɛn we pɔsin kin gɛt we i tek pat pan klinik trial?
Jɔs lɛk ɛnitin, bɛnifit dɛn de ɛn bad tin dɛn de bak. Dɛn go ɛksplen ɔl dis to yu di tɛm we dɛn de du di ``Informed Consent'' prɔses.
Di bɛnifit dɛn we pɔsin kin gɛt
- Fɔ gɛt di laytst tritmɛnt dɛm: Yu kin gɛt di chans fɔ gɛt di laytst tritmɛnt dɛm wae nɔr dɔn rich di jenɛral makit yet, we kin bi mɔ sakrifays pas di tritmɛnt dɛm wae de naw.
- Mɔ kɔntrol pan yu wɛlbɔdi: Lan mɔ bɔt yu sik ɛn tritmɛnt, ɛn woke klos wit yu mɛdikal tim.
- Fɔ ɛp ɔda pipul dɛm: If yu tek pat kin ɛp bɔku bɔku pipul dɛm wae gɛt di sem kayn sik lɛk yu tumara bambay. We yu tek pat as pɔsin we gɛt wɛlbɔdi, yu de ɛp fɔ mek mɛrɛsin sayɛns go bifo.
Risk dɛn we kin apin
- Sayd ɛfɛkt dɛn: Nyu tritmɛnt dɛn we dɛn kin tray fɔ du kin mek dɛn gɛt sayd ɛfɛkt dɛn we dɛn nɔ bin de ɛkspɛkt, we kin nid fɔ gɛt mɛrɛsin.
- Mɔ tɛm ɛn kɔmitmɛnt: Yu kin gɛt fɔ kam na ɔspitul bɔku tɛm, du tɛst, ɛn ivin de na ɔspitul fɔ lɔng tɛm pas aw yu kin de fɔ tritmɛnt.
- Tritmɛnt nɔr woke fayn: De nyu tritmɛnt nɔr kin woke fɔ yu, ɔr e nɔr kin bɛtɛ pas di standad tritmɛnt wae de naw.
- Nɔr fɔ gɛt di nyu tritmɛnt: Insay wan randomized trial, lɛk aw wi bin dɔn tɔk bɔt, yu kin gɛt di standad tritmɛnt we de naw instead ɔf di nyu tritmɛnt, ɔ sɔntɛm yu kin gɛt plasɛbo we nɔ gɛt ɛni aktif mɛrɛsin.
Sɔm kwɛstyɔn dɛn we yu fɔ aks
Bifo yu jɔyn klinik trial, yu kin gɛt bɔku kwɛstyɔn dɛn. Dat na nɔmal tin. Na sɔm impɔtant kwɛstyɔn dɛn we yu kin aks di wan dɛn we de du di risach.
- Wetin mek dɛn de du dis risach?
- Aw lɔng a fɔ put an pan dis?
- If a de gɛt tritmɛnt, aw dɛn go gi mi (as pil, as IV, ɔ ɔda we)?
- Ɔmɔs tɛm a go gɛt fɔ kam? Usay a fɔ kam?
- Aw lɔng i kin tek fɔ rich de wan tɛm?
- A go gɛt fɔ pe fɔ ɛnitin we a de du dis risach?
- Wetin na di prɔblɛm dɛn we kin apin? Aw i go afɛkt mi wɛlbɔdi?
- If a nɔ jɔyn dis ɔ lɛf af-af, wetin go apin to di mɛrɛsin we a kin gɛt ɔltɛm?
- Udat gɛt di wok fɔ kia fɔ mi?
- Dɛn go tɛl mi bɔt di tin dɛn we dis risach dɔn du?
- If dis tritmɛnt wok fayn ɛn dɛn gri fɔ mi, a kin kɔntinyu fɔ gɛt am?
- If a gɛt bad bad tin dɛn we kin apin to mi, a kin lɛf fɔ du di stɔdi?
Wetin na di difrɛns bitwin klinik trial ɛn tritmɛnt ɔltɛm?
Dis na sɔntin we bɔku pipul dɛn kin kɔnfyus bɔt. If yu de tek pat pan klinik trial bikɔs ɔf wan mɛdikal kɔndishɔn, yu ɔspitul wɛlbɔdi prɔblɛm (e.g., dayabitis, ay blɔd prɛshɔn) go kɔntinyu fɔ tek kia ɔf yu rɛgyula dɔktɔ ɛn mɛdikal tim.
Di tim we de in chaj fɔ di klinik trial de pe atɛnshɔn nɔmɔ pan di nyu drɔg ɔ tritmɛnt we dɛn de tɛst. Dɛn kin wach aw yu bɔdi de du di nyu tritmɛnt ɛn trit ɛni sayd ɛfɛkt we kin apin. Dis min se yu go gɛt kia frɔm tu mɛdikal tim dɛn.
Dɔn, klinik trial na di injin we de drɛb mɛdikal sayɛns fɔ go bifo. Pan ɔl we dɛn kin tan lɛk sayɛns to pipul dɛn we de na do, na dɛn at na pipul dɛn we de volontia fɔ ɛp fɔ mek di tritmɛnt dɛn we dɛn de gi bɛtɛ. If dɛn nɔ bin de, di wan dɛn we de stɔdi bɔt dis nɔ go ɛva ebul fɔ no if nyu mɛrɛsin nɔ bad ɔ if i wok.
Mɛsej we dɛn kin kɛr go na os
- Klinik trial, ɔ mɛdikal risach, impɔtant fɔ mek di mɛdikal sayɛns go bifo.
- Di patisipeshon na komplit volontia , ɛn yu gɛt rayt fɔ pul am ɛnitɛm.
- Informed Consent na wan rili impɔtant prɔses we de protɛkt yu. Aks ɛn ansa ɔl di kwɛstyɔn dɛn we yu gɛt.
- Ɛvri risach gɛt bɛnifit dɛn we pɔsin kin gɛt ɛn i gɛt prɔblɛm dɛn bak, ɛn i impɔtant fɔ no dɛn tin ya gud gud wan.
- Strikt lɔ ɛn monitarin prosidur dɛn de fɔ mek shɔ se di wan dɛn we tek pat sef.
- If yu de tink fɔ jɔyn klinik trial, i rili impɔtant fɔ tɔk to yu dɔktɔ bɔt am fɔs.
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