Yisiphi Isidakamizwa Esinobubele Sokusebenzisa Iziguli Ze-Cancer Ne-Oncologists

Ungayithola Kanjani Ukusebenzisa Izidakamizwa Ezomusa Ngokwemithi Yezokuphenya?

Kusho ukuthini ukusetshenziswa kwezidakamizwa ezinesihawu ngeziguli zomdlavuza? Cabanga ngale mibuzo:

Kwenzekani uma kukhona ukuhlolwa okulodwa kuphela okucutshungulwa okungakusiza, kodwa awuhlangabezani nezidingo zokubhaliswa kwesilingo semitholampilo? Kuthiwani uma uhlulekile yonke imithi yokwelashwa ngaphandle kokuthola ukwelashwa okuthembisayo okungakaze kuvunywe yi-FDA?

Uma lokhu kwenzeka, i-FDA inehlelo lokusekela endaweni. Lokhu kuthiwa ukukhululwa komusa noma ukukhuliswa kwezidakamizwa zokuphenya.

Iyini Inhloso Nenhloso "Yokusebenzisa Izidakamizwa Ezinobubele?"

Ukusebenzisa izidakamizwa ezinesihawu kubhekisela ekusetshenzisweni komuthi wokuphenya (izidakamizwa zokuhlola) noma idivaysi yezokwelapha (okungakaze kuvunywe yi-FDA) ngaphandle kwesilingo somtholampilo yokwelashwa uma kungekho ukwelashwa okunye okuwanelisayo okutholakalayo. Ngaphambi kokugunyazwa kwe-FDA, isidakamizwa sokuphenya asikwazi ukudayiswa noma ukudayiswa e-United States.

Iyini i-Investigational New Drug (IND)? - Ukubukezwa Kwezilingo Zemitholampilo kanye Nendlela Yokugunyazwa kwe-FDA

Ngaphambi kokuxoxa ngokusetshenziswa kwezidakamizwa ezinesihawu, kungasiza ekusizeni futhi kuhlathulule inqubo yesidakamizwa noma inqubo entsha njengoba isunguliwe, futhi ekugcineni inganqatshwa noma ivunyelwe inqubo yokugunyazwa ye-FDA yokusetshenziswa umphakathi jikelele. Kule ngxoxo, ngizoyinciphisa inqubo yokwelashwa kuphela.

Isinyathelo sokuqala abacwaningi abasebenzisa lapho behlola ukuthi kungenzeka yini imithi kuhilela izifundo ezingekho abantu. Imithi emisha kulesi silungiselelo ihlolwe kumangqamuzana omdlavuza asetshenziselwa isidlo ebhodini, noma kwezinye izilwane, njengamagundane. Uma lezi zifundo zibhekwa njengezanele, ukuhlolwa kwabantu kuhamba ngezigaba ezintathu zokuhlolwa kwemitholampilo .

Ucwaningo lwesigaba se-Phase 1 lwenziwa ngezinombolo ezincane zabantu, futhi zenzelwe ukuphendula umbuzo: "Ingabe umuthi uphephile?" Ukuhlolwa kwesigaba sesibili yisinyathelo esilandelayo, esenzelwe ukuphendula umbuzo: "Ingabe ukwelashwa kusebenza?" Isigaba sokugcina ngaphambi kokugunyazwa kwe-FDA (noma ukwenqatshwa) yizivivinyo zesigaba sesi-3, izilingo eziqashiwe ukuphendula umbuzo: "Ingabe ukwelashwa kusebenza kangcono kunezokwelapha ezivunyelwe, noma ngemiphumela emibi kakhulu?"

Ukusebenzisa lesi simo, ukusebenzisa imithi enozwela kungaba ukusetshenziswa kwemithi esesinye sezigaba zezifundo zomtholampilo ngaphambi kokugunyazwa kwe-FDA, kodwa hhayi njengomhlanganyeli kwesinye sezivivinyo zomtholampilo.

Lapho Umuntu Omunye Afanelekela Ukusebenzisa Izidakamizwa Ezizwela Ngesihawu (Ukusebenzisa Isizwe Sokuhawukela)?

Okufanelekile, iziguli zomdlavuza ezingase zizuze emthonjeni omusha wokuphenya (IND) zizobhaliswa esivivinyweni somtholampilo esisebenzayo esifunda leso sidakamizwa . Lokho kusho ukuthi abanye abantu abangase bazuze esibhedlela esisetshenziselwa ukuhlolwa ngeke bahambisane nezinqubo ezithile zokubhalisa kulolo cwaningo lwezokwelapha ngenxa yezizathu ezifana nobudala, ukwelapha kwangaphambili, isimo sokusebenza, noma okunye okungafani nemibandela. Kulesi simo, kufanele kube nemigomo emibili:

• Akufanele kube khona ukwelashwa okunye okwanelisayo okutholakala ukuxilonga, ukuqapha, noma ukuphatha isifo esibi, futhi

• Ingozi engenzeka kumuntu ovela emthonjeni wokuphenya (noma inqubo) akuyona enkulu kunengozi ebonakalayo evela kulesi sifo ngokwaso.

Kuyini Ukufinyeleleka Okunwetshiwe Kwezidakamizwa Zokuphenya?

Uma ufunda imibhalo ye-FDA, ungase uzibuze ukuthi umehluko ukhona phakathi kokufinyelela okunwetshiwe nokukhululwa komusa, noma uma kusetshenziswe ngokungafaniyo.Umpendulo wukuthi kunezingxenye ezintathu zokufinyelela okukhulisiwe, okuqala okubhekisela ekusebenziseni umuntu isiguli.Lezi zingxenye zihlanganisa:

• Ukusetshenziswa kwezidakamizwa zokuphenya ngeziguli ngabanye
• Izibalo eziphakathi kweziguli eziphakathi (kuze kube ngu-100), futhi

• Amaqembu amakhulu weziguli (ezingaphezu kwekhulu)

Izidingo Zokufinyelela Ngokweminye Imithi Yezokuphenya I-Cancer

Izidingo ezilandelayo kumele zihlangane ukuze zifake isicelo sokufinyelela ngabanye:

• Isidakamizwa (noma inkambiso) kufanele sibe sesifo, ukuqapha, noma ukwelashwa kwesifo esibi.
• Isiguli kumele singavumeleki kunoma yikuphi ukuvivinywa okuqhubekayo kwemithi yomuthi.
• I-FDA kumele inqume ukuthi ukuxolelwa kokusebenzisa ububele ngeke kuphazamise noma yisiphi isigaba sokuhlolwa okuqhubekayo kwemithi yesidakamizwa.
• Akufanele kube nokunye okwanelisayo noma ukwelashwa okufanisayo okutholakala isiguli, noma isiguli asikwazi ukubekezelela lezi zindlela zokwelapha ezingezinye.
• Isiguli kufanele sibe nesifo sokuxilongwa ngomdlavuza lapho umuthi wokuphenya ubonise umsebenzi. Ngamanye amazwi, i-FDA kumele inqume ukuthi kukhona ubufakazi obanele bokuthi lesi sidakamizwa siphephile futhi sisebenza ngokufanele ukuvikela ukusetshenziswa kwayo kwesiguli esithile.
• Isiguli kumele sithole ukwelashwa okujwayelekile okungaphumeleli.
• Isidakamizwa kumele sisetshenziselwe isimo esibucayi noma esongela ukuphila, lapho izingozi zelashwa lokuhlola ziqhamuka izingozi zokungatholi ukwelashwa. Ngamanye amazwi, ingozi, kuhlanganise nokufa, yokwelashwa kokuhlolwa kubhekwa ukuthi ingaphansi kwesengozi sokufa esi sifweni ngaphandle kokwelashwa.
• Ukuthola lesi sidakamizwa kubandakanya ukubamba iqhaza okusebenzayo kokubili odokotela nesineke
• Udokotela kumele azimisele ukuphatha lesi sidakamizwa futhi aqedele ukuqapha ukwelashwa
• Inkampani eyenza ukuthi izidakamizwa zivumelane ukuhlinzeka ngomuthi (i-FDA ayikwazi "ukuphoqa" inkampani ukuhlinzeka ngezidakamizwa.) Uma inkampani icela ukukhokha izidakamizwa, isiguli kumele sinikeze le ntlawulo.
• I-FDA, emva kokuthola isicelo, izokwenza isinqumo sokuthi noma ukuvumela yini ukukhululwa komusa. Kubalulekile ukuqaphela ukuthi nakuba lokhu kuzwakala sengathi kuyinkimbinkimbi, kusukela ngo-2009 i-FDA ivumile iningi uma izicelo zokudinga izidakamizwa ezintsha zithole .

Inqubo Yohlelo Lokusetshenziswa Kwezidakamizwa Ezizwelayo

Kunezinhlobo ezimbili zezicelo zokusebenzisa ububele. Lokhu kufaka:

• Ukusetshenziswa okuphuthumayo - Esimo esiphuthumayo isicelo singenziwa ngocingo (noma olunye uhlobo olusheshayo lokuxhumana) futhi isikhulu se-FDA singanikeza igunya phezu kwefoni ukuqala ukwelashwa. Udokotela odokotela kumele alandele lokhu ukugunyazwa ngomlomo ngesicelo sokubheka ukusetshenziswa kwezidakamizwa esibhaliwe zingakapheli izinsuku eziyi-15 ukugunyazwa ngamazwi ka-FDA okusebenzisa lesi sidakamizwa. (Uma kungenesikhathi esanele sokuthola imvume evela ebhodini lokubukeza uphenyo (IRB) esimweni esiphuthumayo, ukwelashwa kungase kuqale ngaphandle kokuvunyelwa kwe-IRB uma nje i-IRB ikwaziswa udokotela enikeza ukwelashwa okuphuthumayo kungakapheli izinsuku ezingu-5 zokusebenza.)
• Ukusebenzisa Uzwela (Ukungena Esinye Ukwelashwa) - Ngaphandle kokuba kube nokuphuthumayo okusongela ukuphila, udokotela ophulukisayo kufanele agcwalise uhlelo lokusebenza lokusebenzisa izidakamizwa ezintsha. Uma lolu hlelo lokusebenza selunikezwa i-FDA, i-FDA inezinsuku ezingu-30 lapho isicelo singabuyekezwa khona nesinqumo esenziwe ngokuvuma noma ukuphika. Khumbula ukuthi isikhathi esiningi, isinqumo sizokwabelana nodokotela ophuza ngokushesha ngangokunokwenzeka.

(Njengoba lolu lwazi lushintsha ngesikhatsi, hlola imithombo ye-FDA efakwe ngaphansi kwalesi sihloko ngolwazi olusesikhathini esiphezulu.)

Okudingeka Ukwazi Njengomonde

Kukhona izinto eziningana okumelwe uzikhumbule uma ucabangela ukusetshenziswa komuthi wokuphenya. Lokhu kufaka:

• Isidakamizwa (noma inqubo) ingaba nezingozi ezinkulu.
• Njengoba lesi sidakamizwa (noma inqubo) singakavunyelwa yi-FDA, aziwa ukuthi izidakamizwa ziphambane noma zibi kakhulu kunezidakamizwa ezijwayelekile. Ungase ungatholi noma iyiphi inzuzo eyengeziwe kusuka kumuthi.
• Imiphumela emibi yesikhathi esifushane nemiphumela emibi yesikhathi eside salesi sidakamizwa asaziwa ngokugcwele.

Umthwalo WeDokotela Wakho Ekusetshenzisweni Okudakayo Kwezidakamizwa

Uma ufaka isicelo sokusebenzisa izidakamizwa ezinomusa, kuyoba yindlela yakho yokunakekelwa kwe-oncologist (lowo ozibona ngokwakho ukuze unakekele) ngubani oyoba nomsebenzi wesicelo, ukuphatha, kanye nemibhalo yokwelashwa.

• Udokotela kumele azalise isicelo njengoba kuchaziwe ngenhla.
• Udokotela ozokwelapha uzoba necala lokuthumela iphrothokholo yokwelashwa nokufaka i-FDA ngombiko wemiphumela yokwelapha, isifinyezo, nanoma yimiphi imiphumela emibi.
• Udokotela olaphayo unesibopho sokuthola izidakamizwa ezivela kumkhiqizi / umthuthukisi, futhi ukubika nganoma yimiphi imithi esele ngemuva kokwelashwa kwenziwa.
• Udokotela odokotela kufanele avume ukuqapha isiguli kulo lonke ukwelashwa, elandela yonke imihlahlandlela kanye nemithwalo yemfanelo njengoba ethatha indima yomphenyi kulesi sifo.

_Imithombo:

_{I-National Cancer Institute. Ukufinyelela kwezidakamizwa zokuphenya. Kubuyekezwe 08/04/09. https://www.cancer.gov/about-cancer/treatment/drugs/investigational-drug-access-fact-sheet}

_{I-US Food and Drug Administration (FDA). Ukufinyelela Okunwetshiwe (Ukusebenzisa Isihawu). Kubuyekezwe 02/09/16. http://www.fda.gov/NewsEvents/PublicHealthFocus/EngenayoAccessCompassionateUse/ucm20080392.htm}

_{I-US Food and Drug Administration (FDA). Ukufinyelela okukhulisiwe: Ulwazi lwabagulayo. Kubuyekezwe 03/03/16. http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm}

_{I-US Food and Drug Administration (FDA). Ukufinyelela okukhulisiwe: Ulwazi lwabahlengikazi. Kubuyekezwe ngo-12/15/15. http://www.fda.gov/NewsEvents/PublicHealthFocus/EngenayoAccessCompassionateUse/ucm429624.htm}

_{I-US Food and Drug Administration (FDA). I-IDE Ukufinyelela Kokuqala / Ukwandiswa. Kubuyekezwa 03/26/15. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketI-iDevice /InvestigationalDeviceExemptionIDE/ucm051345.htm}