Kwenzeka ntoni kuvavanyo lweklinikhi?

Umxholo

• Kwenzeka ntoni kwisigaba 0?
• Kwenzeka ntoni kwisigaba I?
• Kwenzeka ntoni kwisigaba II?
• Kwenzeka ntoni kwisigaba III?
• Kwenzeka ntoni kwisigaba IV?
• Umgca wezantsi

Sibandakanya iimveliso esicinga ukuba ziluncedo kubafundi bethu. Ukuba uthenga amakhonkco kweli phepha, sinokufumana ikhomishini encinci. Nantsi inkqubo yethu.

Zithini izilingo zeklinikhi?

Uvavanyo lwezonyango luyindlela yokuvavanya iindlela ezintsha zokufumanisa isifo, ukunyanga okanye ukuthintela iimeko zempilo. Injongo kukuqinisekisa ukuba ngaba into ikhuselekile kwaye iyasebenza.

Izinto ezahlukeneyo ziyavavanywa kuvavanyo lweklinikhi, kubandakanya:

• amayeza
• indibaniselwano yamayeza
• Ukusetyenziswa okutsha kwamayeza akhoyo
• izixhobo zonyango

Ngaphambi kokwenza uvavanyo lweklinikhi, abaphandi benza uphando lwangaphambi kokusebenzisa iiseli zabantu okanye iimodeli zezilwanyana. Umzekelo, banokuvavanya ukuba amayeza amatsha anetyhefu kwisampulu encinci yeeseli zabantu elabhoratri.

Ukuba uphando olwenziwe kwangaphambili luyathembisa, baya phambili ngovavanyo lweklinikhi ukubona ukuba lusebenza njani ebantwini. Ulingo lwezonyango lwenzeka kwizigaba ezininzi xa kubuzwa imibuzo eyahlukeneyo. Isigaba ngasinye sakha kwiziphumo zamanqanaba angaphambili.

Qhubeka ufunda ukuze ufunde ngakumbi malunga nokwenzekayo kwinqanaba ngalinye. Kule nqaku, sisebenzisa umzekelo wonyango olutsha lonyango oluya kwinkqubo yovavanyo lweklinikhi.

Kwenzeka ntoni kwisigaba 0?

Isigaba 0 solingo lweklinikhi lwenziwa ngenani elincinci kakhulu labantu, ngesiqhelo lingaphantsi kwe-15. Abaphandi basebenzisa idosi encinci kakhulu yeyeza ukuqinisekisa ukuba ayinabungozi ebantwini ngaphambi kokuba baqale ukuyisebenzisa ngeedosi eziphezulu kwizigaba zamva .

Ukuba iyeza lisebenza ngokwahlukileyo kunokuba bekulindelwe, abaphandi baya kuthi benze uphando olongezelelekileyo ngaphambi kokuba bathathe isigqibo sokuba baqhubeke nokulingwa.

Kwenzeka ntoni kwisigaba I?

Ngexesha lesigaba sokuqala solingo lweklinikhi, abaphandi bachitha iinyanga ezininzi bejonga iziphumo zonyango kubantu abamalunga nama-20 ukuya kuma-80 abangenazimo zempilo ziphantsi.

Eli nqanaba lijolise ekufumaneni elona dosi liphezulu linokuthathwa ngabantu ngaphandle kwemiphumo emibi. Abaphandi bajonge abathathi-nxaxheba ngokusondeleyo ukuze babone indlela imizimba yabo esabela ngayo kunyango ngeli nqanaba.

Ngelixa uphando lwangaphambi kokuba lubonwe luhlala lubonelela ngolwazi ngokubanzi malunga nedosi, iimpembelelo zonyango kumzimba womntu zinokungaqiniseki.

Ukongeza kuvavanyo lokhuseleko kunye nedosi efanelekileyo, abaphandi bajonge eyona ndlela ilungileyo yokuhambisa ichiza, njengomlomo, ngaphakathi, okanye umxholo.

Ngokuka-FDA, malunga namayeza aya kwinqanaba lesibini.

Kwenzeka ntoni kwisigaba II?

Isigaba II solingo lweklinikhi lubandakanya abathathi-nxaxheba abaliqela abaphila nemeko yokuba amayeza amatsha ayinyango. Zihlala zinikwa idosi efanayo eyafunyanwa ikhuselekile kwisigaba esidlulileyo.

Abaphandi babeke esweni abathathi-nxaxheba iinyanga okanye iminyaka ukuze babone ukuba lisebenza kangakanani na iyeza kunye nokuqokelela ulwazi ngakumbi malunga neziphumo ebezingalindelekanga ezinokubangela.

Ngelixa isigaba II sibandakanya abathathi-nxaxheba abaninzi kunakwizigaba zangaphambili, ayisenkulu ngokwaneleyo ukubonisa ukhuseleko olupheleleyo lwamayeza. Nangona kunjalo, idatha eqokelelwe ngeli nqanaba inceda abaphandi ukuba beze neendlela zokuqhuba isigaba III.

I-FDA iqikelela ukuba malunga namayeza aya kwinqanaba lesithathu.

Kwenzeka ntoni kwisigaba III?

Isigaba se-III solingo lweklinikhi luhlala lubandakanya ukuya kuthi ga kubathathi-nxaxheba abangama-3,000 abanemeko yokuba amayeza amatsha ayenzelwe ukunyanga. Izilingo kweli nqanaba zinokuhlala iminyaka eliqela.

Injongo yesigaba se-III kukuvavanya ukuba lisebenza njani iyeza elitsha xa kuthelekiswa namayeza akhoyo kwimeko efanayo. Ukuqhubela phambili nolu vavanyo, abaphandi kufuneka babonise ukuba amayeza ubuncinci akhuselekile kwaye asebenza njengonyango esele lukhona.

Ukwenza oku, abaphandi basebenzisa inkqubo ebizwa ngokuba yi-randomization. Oku kubandakanya ngokungakhethiyo abanye abathathi-nxaxheba ukuba bafumane amayeza amatsha kunye nabanye ukuba bafumane amayeza akhoyo.

Izilingo zeSigaba III zihlala ziimfama, nto leyo ethetha ukuba akukho mntu uthatha inxaxheba okanye umphandi owaziyo ukuba leliphi na iyeza alithathayo. Oku kunceda ekupheliseni ukukhetha xa kutolikwa iziphumo.

I-FDA ihlala ifuna ulingo lwesigaba sesithathu sonyango ngaphambi kokuvuma amayeza amatsha. Ngenxa yenani elikhulu labathathi-nxaxheba kunye nexesha elide okanye isigaba III, iziphumo ebezingalindelekanga kunye nezexesha elide kunokwenzeka ukuba zibonise ngeli nqanaba.

Ukuba abaphandi babonisa ukuba amayeza ubuncinci akhuselekile kwaye asebenza njengabanye esele bekho kwimarike, i-FDA ihlala iwavuma amayeza.

Rhoqo amayeza aya kwinqanaba lesine.

Kwenzeka ntoni kwisigaba IV?

Uvavanyo lweklinikhi yesiGaba IV lwenzeka emva kokuba i-FDA ivumile amayeza. Eli nqanaba libandakanya amawaka abathathi-nxaxheba kwaye linokuhlala iminyaka emininzi.

Abaphandi basebenzisa eli nqanaba ukuze bafumane ulwazi oluthe kratya malunga nokhuseleko lwexesha elide lonyango, ukusebenza ngempumelelo, kunye nezinye izibonelelo.

Umgca wezantsi

Uvavanyo lwezonyango kunye nezigaba zazo ziyinxalenye ebaluleke kakhulu kuphando lweklinikhi. Avumela ukhuseleko nokusebenza kwamachiza amatsha okanye amayeza ukuba avavanywe ngokufanelekileyo ngaphambi kokuba avunyelwe ukuba asetyenziswe kuluntu ngokubanzi.

Ukuba unomdla wokuthatha inxaxheba kuvavanyo, khangela enye kwindawo yakho ofanelekileyo kuyo.