Ucwaningo ngomuthi omusha? Ake sixoxe ngezivivinyo zemitholampilo! | Nirogi Lanka

Kungenzeka ukuthi uke wezwa ngocwaningo olwenziwe ukuthola imithi emisha noma izindlela zokwelapha. Ngokuvamile, odokotela baxoxa ngalezi ntuthuko. Ungase uzibuze, ziyini ngempela lezi " zivivinyo zemitholampilo "? Akukho okufanele ukhathazeke ngakho; ake sixoxe ngalokhu kalula nangokucacile.

Kuyini Isivivinyo Somtholampilo?

Kalula nje, isivivinyo somtholampilo siwucwaningo lwezokwelapha lapho abantu abazithandelayo behlanganyela khona. Lokhu kubaluleke kakhulu ngoba yindlela kuphela abacwaningi abangathola ngayo ukuthi ukwelashwa okusha kusebenza ngempela futhi kuphephile kuwe nakwabanye.

Kunezinhlobo eziningana zezivivinyo zemitholampilo. Ezinye zigxila ekutholeni izifo ezintsha, kanti ezinye zibheka izindlela zokuzivimbela noma izindlela zokuzixilonga. Kodwa-ke, namuhla sigxile ezivivinyweni zemitholampilo ezenzelwe ukuthola izindlela zokwelapha ezintsha. Abacwaningi bavame ukubiza lezi ngokuthi "izivivinyo zokwelapha." Lezi zifundo zihlola imithi emisha, ukusetshenziswa okusha kwemithi ekhona, amadivayisi ezokwelapha amasha, noma izindlela zokwelapha ezintsha ngokuphelele.

Ungase uzibuze, "Ubani ozithandela lokhu?" Abanye abantu bahlanganyela ngethemba lokuthola ukwelashwa okusha kwesimo ababhekene naso njengamanje. Abanye bangabavolontiya abanempilo abahlanganyela ukusiza abanye futhi banikele ekuthuthukisweni kwesayensi yezokwelapha.

Kwenzekani Ngaphambi Kokuthi Kuqale Ukuhlolwa Kwezokwelapha?

Njengoba ungacabanga, ukwelashwa okusha akukwazi ukunikezwa abantu ngokushesha. Kunenqubo eqinile yokuqinisekisa ukuphepha. Ngokuvamile, lezi zinyathelo ziyalandelwa:

• Ukuhlolwa Kwangaphambi Kokwelashwa: Yonke isilingo somtholampilo siqala ngomqondo wokwelashwa okusha, njengomuthi omusha, inhlanganisela yemithi, noma idivayisi yezokwelapha. Phakathi nalesi sigaba, kwenziwa izivivinyo zelebhu, futhi ngezinye izikhathi ucwaningo oluhilela izilwane lusetshenziswa ukuhlola ukuphepha.
• I-Clinical Trial Protocol: Uma izivivinyo zangaphambi kokwelashwa zisikisela ukuthi ukwelashwa okusha kungase kuphumelele, abacwaningi bakha uhlelo oluphelele olubizwa ngokuthi "i-Clinical trial protocol." Nakuba lezi zinhlelo zihluka, kumele zichaze ngokucacile umgomo wocwaningo, ukwelashwa okuqondile okuvivinywayo, kanye nezilinganiso abacwaningi abazozisebenzisa ukuhlola impumelelo (iziphetho zesilingo).
• Ukubuyekezwa Nokuvunyelwa Yizinhlaka Ezilawulayo (isb., i-FDA): Emazweni afana ne-US, abacwaningi kumele bathole imvume evela ku-Food and Drug Administration (FDA) ngaphambi kokuba baqale. Esifundeni sethu, iziphathimandla zezempilo zasendaweni ezifanayo kumele zibuyekeze futhi zinikeze imvume.
• Ukubuyekezwa Nokuvunyelwa Kwesikhungo: Noma yisiphi isibhedlela esihlanganyela esivivinyweni somtholampilo kumele sibe neBhodi Lokubuyekezwa Kwesikhungo (i-IRB) noma iKomidi Lokuziphatha elihlola ucwaningo. Inhloso eyinhloko yale komidi ukuvikela ukuphepha kwakho namalungelo akho njengomhlanganyeli.

Kuphela ngemva kokuba zonke lezi zimvume sezinikeziwe lapho abacwaningi bangaqala khona ukuqasha abahlanganyeli. Ngezinye izikhathi, baxhumana nabantu asebevele bebhalisiwe, noma udokotela wakho angakudlulisela esivivinyweni sezokwelapha esifanele.

Uma ucabanga ukuhlanganyela, ithimba lezokwelapha elixhumanisayo lizokunikeza incazelo egcwele nenemininingwane. Lokhu kukuvumela ukuthi wenze isinqumo esinolwazi. Le nqubo yaziwa ngokuthi "ukuthola Imvume Enolwazi ."

Kuyini Imvume Enolwazi?

Lena ingxoxo ebalulekile lapho uthola khona lonke ulwazi mayelana nokuhlolwa kwezokwelapha. Ithimba locwaningo lizokuchazela konke ngokucacile.

"Imvume enolwazi" ingaphezu nje kokusayina; kuyilungelo lakho eliyisisekelo!

Bazokunikeza "idokhumenti yemvume enolwazi" futhi bachaze okuqukethwe kwayo iphuzu ngalinye. Lo mbhalo uchaza imigomo nezinqubo zocwaningo. Okubalulekile, uhlanganisa noma yiziphi izingozi ezingaba khona kanye nezinzuzo ezingaba khona. Uphinde uchaze izindlela zokuhlola, ezinye izindlela ongakhetha kuzo uma ukhetha ukungahlanganyeli, isikhathi esilindelekile sesivivinyo, noma yiziphi izidingo zokulandelela , izindleko, nokuthi ngabe kukhona yini isinxephezelo esinikezwayo. Okokugcina, kusho ngokusobala ukuthi ukuhlanganyela kwakho esivivinyweni somtholampilo kungokuzithandela ngokuphelele.

Lo mbhalo ungase ubonise ukuthi isivivinyo "sihleliwe ngokungahleliwe." Cabanga ngalokhu njengokushintshana kwemali; kusho ukuthi akuwona wonke umuntu ohlanganyelayo ongathola ukwelashwa okusha kokuhlola. Uma uphila nesifo esithile futhi ujoyina isivivinyo ngethemba lokuthola ukwelashwa okusha, kubalulekile ukuthi uqonde lokhu okungenzeka.

Ulwazi lwesivivinyo sezokwelapha ngezinye izikhathi lungazwakala luyinkimbinkimbi. Zinike isikhathi futhi uzizwe ukhululekile ukubuza noma yimiphi imibuzo onayo, izikhathi eziningi ozidingayo. Idokhumenti yemvume enolwazi ayiyona inkontileka ekubophayo. Uma ukhetha ukujoyina, uzoyisayina, kodwa noma kunjalo, awuvalelekile. Unelungelo eliphelele lokushintsha umqondo wakho nokuhoxa ocwaningweni nganoma yisiphi isikhathi, ngisho noma sekuqalile.

Kwenzekani Ngesikhathi Sokuhlolwa Kwezokwelapha?

Izivivinyo zemitholampilo zivame ukuqhubeka ngezigaba ezine. Isigaba ngasinye sinenjongo ethile, futhi abacwaningi baqasha abantu abavolontiya esigabeni ngasinye. Nazi izigaba ezine:

• Isigaba 1: Lesi sigaba sivame ukuhilela iqembu elincane (abantu abangu-20 kuya kwabayi-100), abangaba yizisebenzi zokuzithandela ezinempilo ezingenazo izimo zezokwelapha ezaziwayo. Abacwaningi basebenzisa lesi sigaba ukunquma umthamo ofanele nokuqapha noma yimiphi imiphumela emibi engathi sína.
• Isigaba sesi-2: Lesi sigaba sihilela abantu abayi-100 kuya kwabangu-300, bonke abanesimo esithile esifundwayo. Abacwaningi bahlola ukuthi ukwelashwa kusebenza kahle kangakanani futhi baqhubeke nokuqapha noma yimiphi imiphumela emibi yesikhashana noma izinkinga zempilo.
• Isigaba 3: Iqembu elikhulu labahlanganyeli abangu-300 kuya ku-3,000 livame ukubandakanyeka. Yilapho abacwaningi beqinisekisa khona ukuthi ukwelashwa okuvivinywayo kuyasebenza futhi kuphephile. Bangakuqhathanisa nokwelashwa okujwayelekile kwamanje. Emazweni afana ne-US, i-FDA isebenzisa imiphumela yeSigaba 3 ukunquma ukuthi iyakuvumela yini ukwelashwa ukusetshenziswa kabanzi.
• Isigaba 4: Ngisho nangemva kokuvunyelwa yi-FDA, abacwaningi bayaqhubeka nokuqapha ukwelashwa. Ngezinye izikhathi, imiphumela ethile emibiKuvela kuphela ngemva kokuba abantu sebesebenzise umuthi isikhathi eside. Ngakho-ke, abacwaningi baqapha ngokucophelela noma yiziphi izinkinga ezingaba khona zesikhathi eside noma ukusabela okubi.

Kwenzekani ngemva kokuhlolwa kwezokwelapha?

Isivivinyo somtholampilo singaphetha ngezizathu ezahlukahlukene. Isibonelo, ukwelashwa kungathola imvume yomthetho yokusetshenziswa ngumphakathi. Kodwa-ke, uma imiphumela ikhombisa ukuthi ukwelashwa akuphumelelanga njengoba bekulindelekile noma akungcono kunezindinganiso zamanje, isivivinyo singamiswa kusenesikhathi ngaphambi kokuqeda zonke izigaba ezine.

Yiziphi izinzuzo zokujoyina isivivinyo somtholampilo?

Ukubamba iqhaza esivivinyweni somtholampilo kunikeza izinzuzo eziningana ezingaba khona. Uma uphila nesimo sempilo:

• Ungase uthole ukufinyelela ekwelashweni okusha okuthembisayo ngaphambi kokuba kutholakale kabanzi.
• Ungadlala indima ekhuthele kakhulu ekuphatheni ukunakekelwa kwempilo kwakho.
• Ungafaka isandla ekusizeni abanye ababhekene nesimo esifanayo.

Uma ungumvolontiya onempilo, uthola ukwaneliseka kokwazi ukuthi usiza abacwaningi ukuthi bathuthukise izindlela zokwelapha ezingcono zawo wonke umuntu.

Ziyini izingozi?

Izivivinyo zemitholampilo zinezingozi ezithile ezingokwemvelo. Uzokwaziswa ngokugcwele ngalokhu ngesikhathi senqubo "yemvume enolwazi", kodwa uhlale wamukelekile ukucela ulwazi olwengeziwe. Uma kutholakala izingozi ezintsha ngesikhathi sesivivinyo, uzokwaziswa ngokushesha ukuze ukwazi ukuhlola kabusha ukubamba kwakho iqhaza. Ezinye izingozi ezingaba khona zifaka:

• Ukwelashwa kokuhlola kungase kubangele imiphumela emibi engalindelekile edinga usizo lwezokwelapha.
• Isivivinyo singase sithathe isikhathi sakho esiningi kunokunakekelwa okuvamile, njengokubonana nodokotela njalo, ukuhlolwa okukhethekile, noma ukuvakashelwa esibhedlela .
• Ukwelashwa kungase kungasebenzi kuwe, noma kungase kubonakale kungangcono kunokwelashwa okuvamile.
• Ungase ungakutholi nhlobo ukwelashwa okusha, njengoba ungabekwa eqenjini elithola ukunakekelwa okujwayelekile noma i-placebo.

Yimiphi imibuzo okufanele ngiyibuze mayelana nokuhlolwa kwezokwelapha?

Kungokwemvelo ukuba nemibuzo eminingi ngaphambi kokuzithandela. Nazi ezinye okufanele uzicabangele:

• Iyini inhloso yalolu cwaningo?
• Kuzodingeka ngibambe iqhaza isikhathi esingakanani?
• Ukwelashwa kwenziwa kanjani (isib. ngomlomo, nge-IV, ngokufakelwa)?
• Kukangaki ngidinga ukuvakashela lesi sikhungo, futhi sikuphi?
• Kudingeka isikhathi esingakanani ngokuvakasha ngakunye?
• Ingabe zikhona izindleko, noma ingabe umshwalense uzozikhokhela lezi zinqubo?
• Yiziphi izingozi ezithile, futhi zingayithinta kanjani impilo yami?
• Kwenzekani ekunakekelweni kwami ​​​​kwezokwelapha okuvamile uma nginquma ukungahlanganyeli noma ngikhetha ukushiya ucwaningo?
• Ubani ozonginakekela ngezokwelapha ngesikhathi socwaningo?
• Ingabe ngizokwaziswa ngemiphumela yocwaningo?
• Uma ukwelashwa kutholakale ukuthi kuyasebenza, ngizoqhubeka yini nokukuthola?
• Uma ngiba nemiphumela emibi kakhulu, ngingahoxa yini ocwaningweni nganoma yisiphi isikhathi?

Sicela uzizwe ukhululekile ukubuza noma yimiphi eminye imibuzo ongase ube nayo. Ithimba lakho laseNirogi Lanka lilapha ukuzokusekela.

Ubani oqinisekisa ukuphepha ezivivinyweni zemitholampilo?

Izinqubo zokuphepha eziqinile zikhona kuyo yonke inqubo yokuhlolwa kwezokwelapha ukuze kuvikelwe bonke abahlanganyeli.

• Amabhodi Okuphepha Nokuqapha Idatha (ama-DSMB): Lawa akhiwa ochwepheshe bezokwelapha ababuyekeza njalo idatha yesilingo sezokwelapha. Uma lawa mabhodi ethola ukuthi ukwelashwa okuphenywayo akusebenzi noma kubangela imiphumela emibi kakhulu kunalokho obekulindelwe, anegunya lokumisa ucwaningo ngokushesha.
• Ama-Ejensi Okulawula: Izinhlangano ezifana ne-FDA kanye neHhovisi Lokuvikelwa Kocwaningo Lwabantu ziqondisa futhi zilawule zonke izivivinyo zemitholampilo ukuqinisekisa ukunamathela ezindinganisweni zokuphepha. Ngokufanayo, izinhlangano ezifanele zokulawula zendawo ziqapha lezi zinqubo ngaphakathi eSri Lanka.
• Amabhodi Okubuyekeza Ezikhungo (ama-IRB): Ngaphambi kokuba kuqale ukuhlolwa esikhungweni esithile, kumele kuvunyelwe yi-IRB. Lawa mabhodi avikela ukuphepha kwakho njengesisebenzi sokuzithandela ngokuqinisekisa ukuthi awuvezwa ezingozini ezingadingekile. Ama-IRB ngokuvamile ahlanganisa amalungu omphakathi, kanye nodokotela nabacwaningi abangeyona ingxenye yeqembu elithile locwaningo.

Kuyini Isivivinyo Somtholampilo Esingahleliwe?

Esivivinyweni "esingahleliwe", abacwaningi babela izisebenzi zokuzithandela emaqenjini ahlukene ukuze zithole ukwelashwa okuhlukahlukene. Lokhu kungase kuhilele ukuhlola ukwelashwa okusha kocwaningo ngokumelene nezinga lokunakekelwa lamanje, noma ukuqhathanisa ukwelashwa okubili okuhlukile kocwaningo. La maqembu anikezwa ngokungahleliwe—njengokuphonsa uhlamvu lwemali. Le nqubo igcina amaqembu efana, okuvumela abacwaningi ukuthi banqume ngokunembile ukuthi yikuphi ukwelashwa okusebenza kahle kakhulu.

Kuyini Isivivinyo Somtholampilo Esihlukaniswe Ngezindawo Eziningi?

Isivivinyo somtholampilo esihlukaniswe ngokwezigaba yiso lapho imisebenzi yokutadisha yenzeka khona ezindaweni eziningi kunokuba kube yisikhungo esisodwa esiphakathi. Nakuba izivivinyo zendabuko zivame ukudinga izisebenzi zokuzithandela ukuba ziye endaweni ethile, esivivinyweni esihlukaniswe ngokwezigaba, ungase ukwazi ukuhlanganyela ngaphandle komthwalo wokuhamba njalo. Isibonelo, ungathola ukunakekelwa ekhaya, esikhungweni sezempilo sendawo, noma elabhorethri eliseduze.

Ubani ongabamba iqhaza esivivinyweni somtholampilo?

Izivivinyo zemitholampilo zilandela okuthileimihlahlandlela yokufaneleka echaza ukuthi obani abangahlanganyela nabangenakubamba iqhaza. Ukubamba iqhaza akuvulelekile kuwo wonke umuntu ofisa ukujoyina. Lezi ziqondiso ziyahlukahluka ngocwaningo, kodwa ngokuvamile zithinta iminyaka yakho, ubulili, isimo sempilo iyonke, uhlobo oluthile lwesifo onaso, kanye nohlelo lwakho lokwelashwa lwamanje.

Ngizithola kanjani izivivinyo zemitholampilo?

Okokuqala, khuluma nodokotela wakho oyinhloko. Ngenxa yokuthi bayawuqonda umlando wakho wezokwelapha, bahlonyiswe kangcono ukuncoma izivivinyo ezifanele wena. Enye indlela ukusesha izizindalwazi zesilingo semitholampilo eziku-inthanethi. Isibonelo, ungabuyekeza izizindalwazi ezigcinwe yi-US National Center for Biotechnology Information. Ulwazi ngamathuba ocwaningo lwendawo lungatholakala futhi ngezikhungo zakho zezempilo zesifunda.

Izivivinyo zemitholampilo zihluke kanjani ekunakekelweni kwezokwelapha okujwayelekile?

Umehluko omkhulu usekugxilweni kokunakekelwa kwakho. Uma uhlanganyela esivivinyweni, ithimba lakho lezokwelapha eliyinhloko lizoqhubeka nokuphatha izidingo zakho zezempilo eziqhubekayo. Nokho, ithimba lesivivinyo sezokwelapha ligxila kuphela emuthini noma kudivayisi ephenywayo. Liqapha indlela osabela ngayo ekwelashweni okusha futhi linikeze ukunakekelwa kwanoma yimiphi imiphumela emibi engaba khona.

Izivivinyo zemitholampilo yizo eziqhubekisela phambili intuthuko yezokwelapha. Uma ubheka ngaphandle, kungase kubukeke njengesayensi kuphela, kodwa enhliziyweni yayo, kumayelana nabantu abasebenza ndawonye ukuthuthukisa ukunakekelwa kweziguli. Ngaphandle kwezisebenzi zokuzithandela, abacwaningi abakwazi ukunquma ukuthi umbono omusha uzoba ukwelashwa okuphephile nokuphumelelayo ngempela.

Isivivinyo esisodwa singaholela ekwelapheni noma ekwelashweni okuyisisekelo okusiza abantu baphile impilo ende nenempilo. Ngisho nasezivivinyweni ezingavezi imiphumela elindelekile, abacwaningi bathola idatha ebalulekile ebaqondisa empumelelweni yesikhathi esizayo. Ukunquma ukuzithandela esivivinyweni somtholampilo kuyisinqumo esibalulekile. Uma ucabanga ngakho, sicela ungalokothi unqikaze ukubuza imibuzo eminingi ngangokunokwenzeka uze uzizwe uqiniseka ngokuphelele esinqumweni sakho.

Umlayezo Wokuya Nawe Ekhaya

Sithemba ukuthi manje usunokuqonda okucacile kwalokho okushiwo yi-Clinical Trial eNirogi Lanka:

• Ziyizifundo ezibalulekile zocwaningo ezihlose ukuthola izindlela zokwelapha ezintsha.
• "Imvume Yakho Enolwazi" ibalulekile. Zinike isikhathi sokuqonda konke bese ubuza imibuzo ngaphambi kokwenza isinqumo sakho.
• Yaziswa ngokugcwele ngezinzuzo kanye nezingozi ezingaba khona.
• Unelungelo lokuhoxa esifundweni nganoma yisiphi isikhathi.
• Izivivinyo zemitholampilo zingaphansi kwemithethonqubo eqinile kanye nezinqubo zokuphepha.

Uma wena noma othile omaziyo ecabanga ukuhlanganyela ocwaningweni olunjalo, sithemba ukuthi lolu lwazi luwusizo. Njalo xhumana nodokotela wakho ukuze uthole imininingwane eyengeziwe kanye nesiqondiso.

INirogi Lanka: Izivivinyo zemitholampilo, imithi emisha, ucwaningo lwezokwelapha, imvume enolwazi, izigaba zokwelapha, ulwazi lwezempilo, ukubamba iqhaza ngokuzithandela