Risach bɔt wan nyu mɛrɛsin? Lɛ wi tɔk bɔt dis klinik trial!

Yu go dɔn yɛri bɔt risach we dɛn de du fɔ fɛn nyu mɛrɛsin ɔ nyu tritmɛnt. Sɔntɛnde, dɔktɔ dɛn kin tɔk bɔt dɛn tin ya bak. So, yu kin de wɔnda wetin dɛn " klinik trial " ɔ ``klinik trayal'' ya min. Nɔ wɔri, lɛ wi tɔk bɔt dis simpul wan ɛn klia wan.

Wetin na klinik trial?

Fɔ tɔk am simpul wan, klinik trial na mɛdikal risach stɔdi we pipul dɛn kin volontia fɔ tek pat pan. Dis rili impɔtant bikɔs na di wangren we fɔ mek di wan dɛn we de du risach no fɔ tru if nyu tritmɛnt rili wok ɛn if i nɔ bad fɔ pipul dɛn.

Bɔku kayn klinik trial dɛn de. Sɔm na fɔ fɛn nyu sik, sɔm na fɔ avɔyd sik, ɛn sɔm na fɔ no bɔt sik. Bɔt tide wi de tɔk mɔ bɔt klinik trial dɛm we de luk fɔ nyu tritmɛnt dɛm. Di wan dɛm we de stɔdi bɔt mɛrɛsin kin kɔl dɛn tin ya bak "tritmɛnt trayal dɛm." Dɛn tin ya kin tɛst nyu mɛrɛsin dɛn, aw dɛn kin gi di mɛrɛsin dɛn we dɔn de fɔ mɛn difrɛn sik dɛn, nyu mɛrɛsin dɛn , ɔ ɔda tritmɛnt dɛn.

Yu kin de wɔnda se, "Udat go volontia fɔ dis?" Sɔm pipul dɛn kin tek pat bikɔs dɛn gɛt di sik we dɛn de stɔdi, ɛn dɛn kin op fɔ fɛn nyu tritmɛnt. Ɛn pipul dɛn de bak we gɛt wɛlbɔdi ɛn we nɔ gɛt ɛni sik, we want fɔ ɛp ɔda pipul dɛn ɛn ɛp fɔ mek mɛrɛsin sayɛns go bifo.

Wetin kin apin bifo dɛn bigin fɔ du klinik trial?

Tink bɔt am, yu nɔ go jɔs gi pipul dɛn nyu drɔg wan tɛm. Big proses de bifo dat. Bɔku tɛm, dɛn kin fala dɛn tin ya:

• Prɛklinik tɛst: Ɛvri klinik trial kin bigin wit wan aidia fɔ nyu tritmɛnt (lɛk nyu mɛrɛsin, kɔmbayn mɛrɛsin, ɔ mɛrɛsin divays). Dɛn kin du dɛn prɛklinik tɛst ya na lɛbɔretri ɔ pan animal dɛn .
• Klinik trial protɔkɔl: If di fɔs tɛst dɛm we wi bin dɔn tɔk bɔt sho se di nyu tritmɛnt gɛt chans fɔ gɛt sakrifays, di wan dɛn we de du di risach kin mek wan plan fɔ du sɔntin. Dɛn kɔl dis klinik trial protɔkɔl. Dɛn plan ya kin difrɛn frɔm wan to ɔda. Bɔt dɛn fɔ inklud di rizin fɔ di trayal, us tritmɛnt dɛn de tɛst, ɛn wetin di risach pipul dɛn op fɔ mɛzhɔ we di trayal dɔn (trial ɛndpɔynt dɛn).
• Rivyu ɛn aprɔval frɔm rigyuletɔri ɛjɛnshi dɛm lɛk di FDA :Insay kɔntri lɛk Amɛrika, di wan dɛn we de du risach fɔ gɛt aprɔval frɔm di FDA (Food and Drug Administration) bifo dɛn bigin fɔ du klinik trial. Insay wi kɔntri, dɛn nid bak fɔ gɛt aprɔval frɔm di wan dɛn we gɛt fɔ du wit di prɔblɛm.
• Instityushɔnal Rivyu ɛn Aprɔval: Dis involv fɔ rivyu di Instityushɔnal Rivyu Bɔd (IRB) ɔ Etiks Kɔmiti fɔ ɛni ɔspitul we involv pan di klinik trial. Di men tin we dis kɔmiti de pe atɛnshɔn pan na di sef ɛn rayt we di wan dɛn we tek pat pan di trial gɛt.

Na afta dɛn dɔn gɛt ɔl dɛn aprɔval ya, di wan dɛn we de du risach kin bigin fɔ luk fɔ pipul dɛn we rɛdi fɔ tek pat. Sɔntɛnde, dɛn go kɔntakt pipul dɛn we dɔn ɔlrɛdi rɛjista. Bɔku tɛm, yu dɔktɔ kin ivin sɛn yu fɔ go na klinik trial.

If yu de tink fɔ tek pat pan klinik trial, di mɛdikal tim we de kɔdinɛt di risach go fɔs gi yu ful ɛksplen bɔt wetin i de tɔk bɔt. Dɔn yu kin disayd if yu want fɔ tek pat ɔ yu nɔ want fɔ tek pat. Dɛn kɔl dis prɔses fɔ gɛt `` Infɔm Kɔnsɛnt .''

Wetin na `Infɔm Kɔnsɛnt`?

Dis na tɔk we rili impɔtant. Dis na di say we yu go lan di ful ditel bɔt di klinik trial. Di risach tim go ɛksplen ɔltin to yu.

"Informed consent" nɔto jɔs sayn. Na yu rayt!

Dɛn go sho yu "informed consent document" ɛn ɛksplen am to yu stɛp bay stɛp. Dis dɔkyumɛnt de ɛksplen di rizin ɛn di we aw dɛn fɔ du di trial ditayli. I de ɛksplen bak ɛni prɔblɛm ɛn bɛnifit dɛn we pɔsin kin gɛt. I de ɛksplen bak wetin di risach we dɛn go du go bi ɛn wetin yu go ebul fɔ du if yu nɔ tek pat pan di klinik trial. I de ɛksplen bak aw lɔng di trial go las, wetin fɔ fala -ap rikwaymɛnt, us kɔst dɛn go involv, ɛn if yu go gɛt ɛni kɔmpɛnshɔn. Fɔ dɔn, i tɔk klia wan se fɔ tek pat pan di klinik trial na tin we pɔsin kin du fɔ insɛf.

Di liflet kin se di trial na "randomized." I tan lɛk se yu de flip kɔyn. Dis min se nɔto ɔlman we tek pat pan di trial go gɛt di nyu, ɛkspirimɛnt tritmɛnt. If yu gɛt sik ɛn yu de jɔyn di trial wit di op fɔ gɛt nyu tritmɛnt, dis impɔtant fɔ no.

Sɔntɛnde, di ditil dɛm fɔ di klinik trial kin kɔmplikt smɔl ɛn i kin at fɔ ɔndastand. So, tek yu tɛm ɛn aks ɛni kwɛstyɔn we yu gɛt, bɔku tɛm we yu want. Di `Informed Consent` fɔm na wetin di klinik trial de tɔk bɔt.Nɔto kɔntrakt bitwin yu ɛn di dɔktɔ dɛn we de du di risach. If yu disayd fɔ jɔyn di stɔdi, yu go gɛt fɔ sayn da pepa de. Bɔt if yu sayn, dat nɔ min se yu dɔn tay am. Yu gɛt di rayt fɔ chenj yu maynd ɛn pul yusɛf kɔmɔt ɛnitɛm, ivin afta di stɔdi dɔn bigin.

Wetin kin apin we dɛn de du klinik trial?

Tipikli fכ pat dεm de fכ wan klinik trial. Ɛni pat gɛt wan patikyula rizin. Risach pipul dɛn kin luk fɔ nyu volontia dɛn fɔ ɛni pat. Di 4 pat dɛn na:

• Faz 1: Dis kin involv smɔl grup fɔ pipul dɛm (bitwin 20 ɛn 100). I go mɔs bi se dɛn na pipul dɛn we gɛt wɛlbɔdi ɛn we dɛn nɔ no bɔt ɛni mɛrɛsin. Risach pipul dɛn kin yuz dis pat fɔ no di rayt doz fɔ di mɛrɛsin ɛn fɔ si if di tritmɛnt kin mek ɛni siriɔs sayd ɛfɛkt .
• Faz 2: Dis kin involv bitwin 100 ɛn 300 pipul dɛm. Dɛn ɔl gɛt wan patikyula sik. Insay dis pat, di wan dɛn we de du risach kin luk fɔ si if di tritmɛnt rili wok ɛn if i nyu ɔ i gɛt mɔ siriɔs sayd ɛfɛkt pas aw i bin de bifo.
• Faz 3: Dis pat kin involv bitwin 300 ɛn 3,000 pipul dɛm. Dis na di say we di wan dɛn we de du risach kin mek shɔ se di tritmɛnt we dɛn de tray fɔ du rili wok ɛn i nɔ bad. Dɛn kin kɔmpia am bak to di tritmɛnt dɛn we dɛn dɔn gɛt. Insay kɔntri lɛk Amɛrika, di FDA kin disayd if dɛn fɔ gri fɔ di tritmɛnt fɔ mɔ pipul dɛn bay di rizɔlt dɛn we dis faz 3 trayal dɔn gɛt.
• Faz 4: Risach pipul dɛn kin kɔntinyu fɔ wach di tritmɛnt ivin afta di FDA dɔn gri fɔ am. Bikɔs sɔm nyu tritmɛnt dɛn kin gɛt bad bad tin dɛn we kin apin afta pipul dɛn dɔn de yuz di mɛrɛsin fɔ sɔm tɛm, di wan dɛn we de stɔdi bɔt dis kin kɔntinyu fɔ luk fɔ di bad tin dɛn we kin apin ɔ ɔda prɔblɛm dɛn.

Wetin kin apin afta dɛn dɔn du klinik trial?

Wan klinik trial kin dɔn fɔ difrɛn rizin dɛn. Fɔ ɛgzampul, wan tritmɛnt we bin de na di risach pat kin dɔn gɛt FDA aprɔval ɛn i kin bi fɔ mɔ pipul dɛn. Bɔt sɔm tɛm, if di tɛst dɛn sho se di tritmɛnt nɔ wok lɛk aw dɛn bin de tink, ɔ i nɔ bɛtɛ pas di tritmɛnt dɛn we dɔn de, dɛn kin stɔp di klinik trial bifo dɛn dɔn ɔl di 4 pat dɛn.

Wetin na di bɛnifit dɛn we pɔsin kin gɛt we i jɔyn fɔ du klinik trial?

Bɔku bɛnifit dɛn de we pɔsin kin gɛt we i de pan klinik trial. If yu de sɔfa wit wan patikyula sik:

• Sɔntɛm chans de fɔ gɛt nyu tritmɛnt dɛn we go wok pas di tritmɛnt dɛn we de naw.
• Yu kin ple mɔ aktif rol fɔ disayd bɔt yu wɛlbɔdi biznɛs .
• Yu kin ɛp ɔda pipul dɛn we gɛt di sem sik lɛk yu.

If yu gɛt wɛlbɔdi, yu go gɛt di gladi at fɔ ɛp di wan dɛn we de du risach fɔ fɛn bɛtɛ tritmɛnt fɔ ɔda pipul dɛn.

Wetin na di prɔblɛm dɛn we kin apin?

Klinik trial kin kam wit sɔm risk dɛm. Dɛn go tɛl yu bɔt dɛn risk ya we yu gi yu "informed consent." Bɔt yu kin aks fɔ mɔ infɔmeshɔn ɛnitɛm. If di risk dɛn chenj we dɛn de tray, ɔ if nyu risk dɛn kam, dɛn go tɛl yu bɔt dɛn. Dɔn yu kin tink bak if yu fɔ tek pat. Sɔm pan di prɔblɛm dɛn we kin apin na:

• De tritmɛnt, wae stil de na di risach phase , kin mek yu gɛt sayd ɛfɛkt wae kin nid fɔ gɛt mɛrɛsin.
• Dis tɛst kin tek lɔng pas aw dɛn kin trit yu sik. Fɔ ɛgzampul, pipul dɛn kin go to dɔktɔ, tɛst, ɔ ɔspitul pas aw dɛn kin du am.
• Di tritmɛnt dɛn we dɛn kin yuz fɔ du risach nɔ kin wok, ɔ dɛn nɔ kin fayn lɛk di tritmɛnt dɛn we dɛn kin gi.
• Sɔntɛm yu nɔ go gɛt di tritmɛnt we dɛn de tɛst we dɛn de du risach. Yu kin gɛt di standad tritmɛnt fɔ yu kɔndishɔn, ɔ dɛn kin put yu na ``plesbo'' grup, usay yu nɔ kin gɛt ɛni tritmɛnt atɔl.

Us kwɛstyɔn dɛn a fɔ aks bɔt klinik trial?

Lɛk bɔku pipul dɛn, yu kin gɛt bɔku kwɛstyɔn bɔt aw fɔ volontia fɔ du klinik trial. Na sɔm kwɛstyɔn dɛn we yu kin aks:

• Wetin mek dɛn de du dis stɔdi?
• Aw lɔng a nid fɔ tek pat pan dis stɔdi?
• If a de gɛt tritmɛnt, aw dɛn go gi mi (as pil, as `IV`, as `implant`, ɛn ɔda tin dɛn)?
• Ɔmɔs tɛm a go gɛt fɔ kam? Usay a fɔ kam?
• Aw lɔng i kin tek fɔ kam wan tɛm?
• A go gɛt fɔ pe fɔ ɛni pat pan dis stɔdi? Yu tink se mi inshɔrans go kɔba ɛnitin fɔ dis?
• Wetin na di bad tin dɛn we kin apin we dis stɔdi de apin? Aw dis go afɛkt mi wɛlbɔdi?
• Wetin go apin to mi mɛrɛsin if a nɔ tek pat ɔ pul mi pan di stɔdi?
• Udat de in chaj fɔ mi mɛrɛsin?
• A go gɛt ɛni rizɔlt frɔm dis stɔdi?
• If dɛn gri fɔ tek di tritmɛnt, a go kɔntinyu fɔ gɛt am?
• If a gɛt siriɔs sayd ɛfɛkt frɔm di tritmɛnt, a kin lɛf fɔ du di stɔdi?

Nɔ fred fɔ aks nɔto jɔs dɛn kwɛstyɔn ya, bɔt ɛnitin we yu tink bɔt.

Udat de mek shɔ se di klinik trial dɛn sef ?

Dɛn dɔn impruv sefty mɛsej dɛn ɔlsay na di klinik trial prɔses fɔ mek shɔ se di wan dɛn we tek pat sef:

• Data Sefty ɛn Monitorin Bɔd dɛn (DSMB dɛn): .Dɛn pipul ya na pipul dɛn we sabi bɔt mɛrɛsin. Dɛn kin rivyu di rizɔlt dɛn ɔlsay na di klinik trial. If dɛn disayd se di tritmɛnt we dɛn de chɛk nɔ de wok ɔ di sayd ɛfɛkt dɛn wɔs pas aw dɛn bin de tink, dɛn bɔd ya kin stɔp di trial kwik kwik wan.
• Gɔvmɛnt ɛjɛnshi dɛm: Ejensi dɛm lɛk FDA ɛn di Ɔfis fɔ Human Risach Protɛkshɔn de rigul ɛn ɔvasayz ɔl di klinik trial dɛm na Amɛrika. Na di sem tin fɔ di ɛjɛnshi dɛm we de rigul di lɔ na Sri Lanka.
• Instityushɔnal Rivyu Bɔd (IRB): Dɛn bɔd ya, we de na say dɛn we dɛn de du risach, fɔ gri fɔ mek dɛn du klinik trial bifo dɛn du am. Dɛn bɔd dɛn ya de mek shɔ se di wan dɛn we de wok fɔ di wan dɛn we de wok fɔ dɛn nɔ de gɛt prɔblɛm dɛn we nɔ nid fɔ apin ɛn dɛn de protɛkt dɛn sef. IRB dɛn kin gɛt pipul dɛn na di kɔmyuniti, ɛn bak dɔktɔ ɛn risach pipul dɛn we nɔ de pan di risach tim.

Wetin na `Randomized Klinik Trial`?

Insay wan "randomized" trial, risechar dεm put volontia dεm insay difrεn grup dεm. Ɛni grup kin gɛt difrɛn tritmɛnt. Sɔntɛm dɛn de tɛst wan standad tritmɛnt wit wan ɛkspirimɛnt tritmɛnt, ɔ tu ɛkspirimɛnt tritmɛnt. Dɛn kin put di grup dɛn insay dɛn grup ya randomly, lɛk fɔ flip kɔyn. Dɔn di grup dɛn na di sem. Dat kin mek am izi fɔ di wan dɛn we de du risach fɔ no us tritmɛnt bɛtɛ.

Wetin na Disɛntralayz Klinik Trayal?

Disɛntralayz klinik trial na wan usay dɛn kin du di trayal na bɔku say dɛn, pas fɔ jɔs du wan. Frɔm trade trade, klinik trial dɛn kin nid fɔ mek volontia dɛn travul go na wan patikyula say. Bɔt, insay disɛntralayz trial, volontia dɛn kin tek pat ɛn nɔ nid fɔ travul. Fɔ ɛgzampul, yu kin gɛt tritmɛnt na yu os, na wɛlbɔdi sɛnta we de nia yu, ɔ na lɛbɔretri we de nia yu.

Udat kin tek pat pan klinik trial?

Klinik trial dɛn gɛt gaydlayn dɛn fɔ ebul fɔ tek pat . Dɛn kin tɛl yu udat go ebul fɔ tek pat ɛn udat nɔ go ebul fɔ tek pat. Nɔto ɔlman we want fɔ de na klinik trial kin tek pat. Dɛn gaydlain ya kin difrɛn. Bɔt, in jɛnɛral, dɛn kin dipen pan tin dɛm lɛk yu ej, man ɔ uman, ɔl yu wɛl bɔdi, di kayn sik wae yu gɛt, ɛn di tritmɛnt dɛm wae yu de tek naw.

Aw a go no bɔt klinik trial dɛm?

Fɔs, tɔk to yu dɔktɔ we de trit yu. I no yu ɛn yu sik, so i kin tɛl yu fɔ du di tɛst dɛn we go fayn fɔ yu. Wan ɔda we na fɔ luk di klinik trial database dɛn na di intanɛt. Fɔ ɛgzampul, yu kin luk di database we di US Nashɔnal Sɛnta fɔ Bayoteknɔlɔji Infɔmeshɔn de kia fɔ. Insay Sri Lanka, yu kin fɛn infɔmeshɔn bak bɔt dɛn kayn risach ya tru di wɛlbɔdi institiushɔn dɛn we gɛt fɔ du wit am.

Aw klinik trial difrɛn frɔm tritmɛnt ɔltɛm?

Di difrɛns na di kayn mɛrɛsin we dɛn de gi yu. If yu sik ɛn tek pat pan klinik trial, yu rɛgyula mɛdikal tim go tek kia ɔf yu wɛlbɔdi prɔblɛm dɛn we de kɔntinyu. Di klinik trial tim go jɔs pe atɛnshɔn pan di nyu drɔg ɔ divays we dɛn de tɛst. Di tim go wach aw yu go ansa di tritmɛnt we dɛn de du di invɛstigeshɔn ɛn trit ɛni sayd ɛfɛkt we yu go gɛt.

Klinik trial na wetin advans mɛrɛsin. If yu luk am na do, i go tan lɛk se na sayɛns nɔmɔ i de tɔk bɔt. Bɔt i rili de bɔt di pipul dɛn we de ɛp fɔ mek mɛrɛsin bɛtɛ. If volontia nɔ de, di wan dɛn we de du risach nɔ go ebul fɔ no if wan aidia go rili bi tritmɛnt we sef ɛn we go wok fayn.

Wan trayal kin mɛn wan sik ɔr kin fɛn wan fayn tritmɛnt wae kin ɛp pipul dɛm fɔ liv lɔng. Ivin if wan trayal nɔr prodyuz di rizulyt we dɛn bin de ɛkspɛkt, i kin stil lid di risach pipul dɛm to difrɛn dairekshɔn ɛn ajɔst mɔr saksesful rizulyt. Fɔ disayd fɔ volontia fɔ wan klinik trial na big disizhɔn. If yu de tink bɔt am, nɔr shem fɔ aks ɛni kwɛstyɔn wae yu gɛt, ɔltɛm as yu want, te yu fil se yu gɛt kɔnfidɛns pan yu disayd.

Mɛsej we dɛn kin kɛr go na os

So, a op se yu dɔn ɔndastand mɔ naw bɔt wetin na ``Klinik Trayal'' we wi bin tɔk bɔt.

• Dis na impɔtant risach fɔ fɛn nyu tritmɛnt.
• Yu "Informed Consent" rili impɔtant. No ɔltin, aks kwɛstyɔn, ɛn disayd fɔ du sɔntin.
• Yu fɔ no di bɛnifit dɛn ɛn di bad tin dɛn we kin apin to yu.
• Yu gɛt rayt fɔ pul yusɛf kɔmɔt pan di tɛst ɛnitɛm.
• Dɛn tin ya de ɔnda strikt rigyuleshɔn ɛn sikyɔriti mɛsej dɛn.

If yu ɔ pɔsin we yu sabi de tink bɔt fɔ tek pat pan stɔdi lɛk dis, dis infɔmeshɔn go ɛp dɛnsɛf. Tɔk to yu dɔktɔ ɔltɛm fɔ no mɔ.

` Klinik trial, nyu drɔgs, mɛdikal risach, infɔm kɔnsɛnt, tritmɛnt faz, wɛlbɔdi infɔmeshɔn, volontia wok