Kwenzekani Esivivinyweni Somtholampilo?

-Delile

• Kwenzekani esigabeni 0?
• Kwenzekani esigabeni I?
• Kwenzekani esigabeni II?
• Kwenzekani esigabeni III?
• Kwenzekani esigabeni IV?
• Okubalulekile

Sifaka imikhiqizo esicabanga ukuthi ilusizo kubafundi bethu. Uma uthenga ngezixhumanisi ezikuleli khasi, singathola ikhomishini encane. Nansi inqubo yethu.

Yiziphi izivivinyo zokwelashwa?

Ukuhlolwa kwemitholampilo kuyindlela yokuhlola izindlela ezintsha zokuxilonga, zokwelapha noma zokuvimbela izimo zezempilo. Umgomo ukuthola ukuthi ngabe okuthile kuphephile futhi kuyasebenza yini.

Izinto ezahlukahlukene zihlolwa ngokuhlolwa kwemitholampilo, kufaka phakathi:

• imithi
• inhlanganisela yemithi
• ukusetshenziswa okusha kwemithi ekhona
• amadivayisi wezokwelapha

Ngaphambi kokwenza isivivinyo somtholampilo, abaphenyi benza ucwaningo lwangaphambi kokusebenzisa amasiko amaseli womuntu noma izinhlobo zezilwane. Isibonelo, bangahlola ukuthi umuthi omusha unobuthi kumasampula amancane amangqamuzana omuntu elabhorethri.

Uma ucwaningo lwe-preclinical luyathembisa, baya phambili ngesivivinyo somtholampilo ukubona ukuthi kusebenza kanjani kubantu. Ukuhlolwa kwemitholampilo kwenzeka ngezigaba eziningana lapho kubuzwa khona imibuzo ehlukile. Isigaba ngasinye sakha emiphumeleni yezigaba ezedlule.

Qhubeka ufunda ukuze ufunde kabanzi ngokwenzeka esigabeni ngasinye. Kule ndatshana, sisebenzisa isibonelo somuthi omusha wokwelashwa odlula kwinqubo yokuhlolwa komtholampilo.

Kwenzekani esigabeni 0?

Isigaba 0 sesivivinyo somtholampilo senziwa ngenani elincane kakhulu labantu, imvamisa iba ngaphansi kuka-15. Abaphenyi basebenzisa umuthi omncane kakhulu wemithi ukuqinisekisa ukuthi akulimazi kubantu ngaphambi kokuba baqale ukuwusebenzisa ngamanani aphezulu ezigabeni zakamuva .

Uma umuthi usebenza ngokuhlukile kunalokho obekulindelwe, abaphenyi kungenzeka benze olunye ucwaningo ngaphambi kokuthatha isinqumo sokuthi liyaqhubeka yini icala.

Kwenzekani esigabeni I?

Ngesikhathi sesigaba sokuqala sesivivinyo somtholampilo, abaphenyi bachitha izinyanga ezimbalwa bebheka imiphumela yomuthi kubantu ababalelwa kuma-20 kuye kwangama-80 abangenazo izimo zempilo ezingaphansi.

Lesi sigaba sihlose ukuthola umthamo ophakeme kunawo wonke abantu ongawuthatha ngaphandle kwemiphumela emibi kakhulu. Abaphenyi baqapha ababambiqhaza eduze kakhulu ukubona ukuthi imizimba yabo isabela kanjani emithini ngesikhathi salesi sigaba.

Ngenkathi ucwaningo lwe-preclinical luvame ukuhlinzeka ngemininingwane ejwayelekile mayelana nokufakwa kwesikali, imiphumela yomuthi emzimbeni womuntu ingaqagelwa.

Ngaphezu kokuhlola ukuphepha nomthamo ofanele, abaphenyi baphinde babheke indlela engcono yokusebenzisa umuthi, njengomlomo, ngomjovo, noma ngezihloko.

Ngokuya nge-FDA, cishe imithi iya esigabeni II.

Kwenzekani esigabeni II?

Isigaba II sesivivinyo somtholampilo sibandakanya ababambiqhaza abangamakhulu amaningana abaphila nesimo sokuthi umuthi omusha wenzelwe ukuwelapha. Imvamisa banikezwa umthamo ofanayo otholakale uphephile esigabeni esedlule.

Abaphenyi baqapha ababambiqhaza izinyanga noma iminyaka eminingana ukuze babone ukuthi umuthi usebenza kangakanani nokuthi baqoqe imininingwane eminingi ngemiphumela engemihle engase ibangelwe.

Ngenkathi isigaba II sibandakanya ababambiqhaza abaningi kunezigaba zangaphambilini, kusenkulu ngokwanele ukukhombisa ukuphepha okuphelele komuthi. Kodwa-ke, imininingwane eqoqwe ngalesi sigaba isiza abaphenyi ukuthi baqhamuke nezindlela zokwenza isigaba III.

I-FDA ilinganisela ukuthi mayelana nemithi iya esigabeni III.

Kwenzekani esigabeni III?

Isigaba III sesivivinyo somtholampilo ngokuvamile sifaka ababambiqhaza abangafika kwabangu-3 000 abanesimo sokuthi umuthi omusha wenzelwe ukuwelapha. Izilingo kulesi sigaba zingahlala iminyaka eminingana.

Inhloso yesigaba III ukuhlola ukuthi umuthi omusha usebenza kanjani ngokuqhathanisa nemithi ekhona yesimo esifanayo. Ukuqhubekela phambili nokuhlolwa, abaphenyi kudingeka bakhombise ukuthi umuthi okungenani uphephe futhi usebenza ngempumelelo njengezinketho zokwelashwa ezikhona.

Ukwenza lokhu, abaphenyi basebenzisa inqubo ebizwa ngokuthi yi-randomization. Lokhu kufaka phakathi ukukhetha ngezikhathi ezithile abanye babambiqhaza ukuthi bathole umuthi omusha kanti abanye bazothola umuthi okhona.

Izilingo zeSigaba III zivame ukungaboni kahle, okusho ukuthi lowo obambe iqhaza noma nomphenyi abazi ukuthi umhlanganyeli uthatha muphi umuthi. Lokhu kusiza ukuqeda ukuchema lapho kuhunyushwa imiphumela.

I-FDA ivame ukudinga isivivinyo somtholampilo wesigaba III ngaphambi kokuvumela umuthi omusha. Ngenxa yenani elikhulu lababambiqhaza nobude besikhathi noma isigaba III, imiphumela emibi engajwayelekile neyesikhathi eside kungenzeka ibonakale kulesi sigaba.

Uma abaphenyi bekhombisa ukuthi umuthi okungenani uphephe futhi usebenza ngempumelelo njengoba eminye isivele ikhona emakethe, i-FDA imane ivume umuthi.

Cishe imishanguzo idlulela esigabeni IV.

Kwenzekani esigabeni IV?

Izivivinyo zomtholampilo weSigaba IV zenzeka ngemuva kokuthi i-FDA ivume imithi. Lesi sigaba sithinta izinkulungwane zabahlanganyeli futhi singahlala iminyaka eminingi.

Abaphenyi basebenzisa lesi sigaba ukuthola ulwazi oluthe xaxa mayelana nokuphepha kwesikhathi eside kwemithi, ukusebenza kahle, kanye nezinye izinzuzo.

Okubalulekile

Ukuhlolwa kwemitholampilo kanye nezigaba zazo ngazinye ziyingxenye ebaluleke kakhulu yocwaningo lomtholampilo. Bavumela ukuphepha nokusebenza kwemithi emisha noma izindlela zokwelashwa ukuthi kuhlolwe kahle ngaphambi kokuba kuvunyelwe ukusetshenziswa emphakathini jikelele.

Uma unentshisekelo yokubamba iqhaza esivivinyweni, thola esisodwa endaweni yangakini okufanelekelayo.