Zvinodhaka Zvine Mutsa Zvinoshandisa Mishonga yeCancer Patients uye Oncologists

Unogona Sei Kuwana Dhiyabhorosi Mishonga Yokushandisa Mushonga Wezvinodhaka?

Chii chinorehwa nekushandiswa kwemishonga ine tsitsi kune vanorwara nekenza? Funga nezvemibvunzo iyi:

Chii chinoitika kana pane chirwere chimwe chete chinodzidzwa chinogona kukubatsira, asi iwe haunosangana nekliniki yekuongorora kunyoresa zvinoda? Ko kana iwe wakakundikana mishonga dzose dzisiri kunze kwemushonga unovimbisa usingati wagamuchirwa neCDA?

Apo izvi zvikaitika, FDA ine chirongwa chokuchengetedza panzvimbo. Izvi zvinonzi kushandiswa kunzwira tsitsi kushandiswa kana kuwedzerwa kuwanikwa kwezvinodhaka zvekuongorora.

Chii chinoreva uye chinangwa che "Kushandisa Zvinodhaka Zvinodhaka?"

Kushandisa zvinodhaka zvinodhaka kunoreva kushandiswa kwekutsvaga zvinodhaka (experimental drug) kana chirongwa chechiremba (chisati chagamuchirwa neDFA) kunze kwechirwere chekuongorora kurapwa kana pasina mushonga unogutsa unogoneka. Vasati vambomira FDA, chirwere chekuongorora hachigoni kutengeswa kana kutengeswa muUnited States.

Chii chinonzi Investigational New Drug (IND)? - Kudzokorora kweKliniki Mitsva uye Nzira yeDhivhodhi yeDhiyabhorosi

Usati wataura nezvekunzwira tsitsi kwemishonga inoshandiswa, zvinogona kubatsira kutsigira uye kurondedzera kushandiswa kwemishonga kana mushonga mutsva sezvazvakagadzirwa, uye pakupedzisira kana kurambwa kana kugamuchirwa nedhigiriro reDAA rekushandiswa kwevanhu vose. Pamusoro pekukurukurirana uku, ndichagadzirisa nzira yekurapa mishonga chete.

Nhanho yekutanga vatsvakurudzi vanoshandisa kana kuongorora mishonga inogona kuitika inosanganisira kusadzidza kwevanhu. Mishonga mitsva mumamiriro ezvinhu aya anoongororwa pamasero ekenza anowanikwa mune imwe mudziyo murabhu, kana kune dzimwe mhuka, dzakadai semakonzo. Apo zvidzidzo izvi zvinotorwa zvakakwana zvakakwana, kuedzwa kwevanhu zvino kunopinda mumapoka matatu emakiriniki ekuedzwa .

Chikamu 1 zvidzidzo zvechipatara zvinowanikwa pamaduku mashoma evanhu, uye zvakagadzirirwa kupindura mubvunzo uyu: "Chirwere ichi chakachengeteka here?" Chikamu 2 miedzo ndiyo danho rinotevera, rakagadzirirwa kupindura mubvunzo uyu: "Ko kurapa kunoshanda here?" Chikamu chekupedzisira pamberi peRWD chibvumirano (kana kuramba) chirongwa chechikamu chechipatara chechitatu, miedzo inoshandiswa kupindura mubvunzo uyu: "Ko kurapwa kunobatsira zviri nani kudarika mishonga inogamuchirwa, kana kuti zvishoma nezvigumisiro?"

Kushandisa nyaya iyi, kushandiswa kwemishonga ine tsitsi kunoshandiswa kwemishonga iri mune chimwe chezvikamu zvekuongorora zvipatara pamberi peDAA, asi kwete sechikamu cheimwe yemakiriniki.

Apo Mumwe Munhu Angakwanisa Kufanirwa Nekushandisa Zvinodhaka Zvinodhaka (Kushandisa Kunzwira Ngoni)?

Zvakakodzera, varwere vekenza vanogona kubatsirwa nekutsvakurudza mishonga yemishonga (IND) vaizonyora muchechi yekutengesa inoshandiswa iyo iri kudzidza iyo mishonga . Izvozvo zvakati, vamwe vanhu vanogona kubatsirwa nemishonga inodzidzwa vangave vasina kukodzera mitemo chaiyo yekunyora mune izvo zvechipatori kutongwa nekuda kwezvikonzero zvakadai sezera, marapirwo apfuura, mamiriro ekushanda, kana zvimwe zvisingaiti mamiriro. Muchiitiko ichi, 2 inyanzvi inofanira kusangana:

• Ikoko haufaniri kuva nehupi hunogutsa huripo hunoonekwa kuti huongorore, kuongorora, kana kubata chirwere chakakomba, uye

• Iyo ngozi inogona kuitika kumunhu kubva pechirwere chekuongorora (kana chirongwa) haisi chikuru kudarika ngozi inogona kuitika kubva pachirwere chacho pachayo.

Chii chinonzi Expanded Access kuInvestigational Drugs?

Kana iwe ukaverenga kuburikidza nemagwaro eDAA, unogona kushamisika kuti musiyano uripi pakati pekuwedzerwa kushandiswa uye kusunungurwa kushandiswa kushandiswa, kana kuti iko kushandiswa zvakasiyana-siyana.Kupindura ndechokuti kune zvikamu zvitatu zvekuwedzerwa kushandiswa, nekutanga kutaura nezvekushandiswa nomumwe munhu mwoyo murefu.Vanhu ava vanosanganisira:

• Kushandiswa kwemishonga yekuongorora kune mumwe munhu varwere
• Nechirwere chepakati pevanhu varwere (kusvika ku100), uye

• Mapoka makuru evarwere (anopfuura 100)

Zvinoda Kuti Munhu Awane Chimwe Chekushandisa Zvinodhaka Zvinodhaka zveKenza

Izvo zvinotevera zvinofanirwa kusangana kuti zvikumbire kuwana munhu mumwe chete:

• Chirwere (kana kuti chirongwa) chinofanira kuva chekucherechedza, kuongorora, kana kurapwa kwechirwere chakakomba.
• Murwere anofanira kunge asingabvumirwi kune chero zvipi zvese zvinoramba zvichirwara zvechirwere.
• I-FDA inofanira kusarudza kuti kusununguka kushandiswa kwetsitsi hakuzovhiringidzi nhanho chero ipi zvayo yekuongororwa kwechirwere chechirwere.
• Ikoko haufaniri kuva nechinangwa chinogutsa kana chakafanana nemishonga inowanikwa kune murwere, kana murwere asingagoni kubvumira izvi zvisingashandisi kurapwa.
• Murefu anofanira kunge ane kenza kuongororwa iyo chirwere chekuongorora chiratidze basa. Mune mamwe mazwi, FDA inofanira kusarudza kuti kune uchapupu hunokwana hwokuti mishonga yakachengeteka uye inobudirira kururamisa kushandiswa kwayo kune mumwe murwere.
• Murwere anofanira kunge akawana chirwere chisingaiti.
• Mushonga wacho unofanira kushandiswa nokuda kwehutano hwakakomba kana hupenyu huri kutyisidzira, umo mungozi dzehutano hwekuedza dzinopfuura zvikwereti zvekusagamuchira kurapwa. Mune mamwe mazwi, njodzi, kusanganisira kufa, yekurapa kwekuedza kunoonekwa kunge iri pasi pengozi yekufa kubva pachirwere pasina kurapwa.
• Kuwana mushonga uyu kunosanganisira kubatanidzwa kwechiremba uye murwere
• Chiremba anofanira kunge achida kutarisira mishonga iyi uye kupedza kurapa kurapwa
• Imwe iyo inoita kuti chirwere ichi chibvumirane kupa mishonga (iyo FDA haigoni "kumanikidza" kambani kupa mishonga.) Kana kambani inokumbira kubhadhara kwechirwere, murwere anofanira kupa mubhadharo uyu.
• I-FDA, mushure mokugamuchira chikumbiro, ichaita chisarudzo chekuti kana kwete kubvumira kushandiswa kwetsitsi kusununguka. Zvakakosha kuziva kuti kunyange zvazvo izvi zvichiita sekutambudzika kwakaoma, kubvira muna 2009 FDA yakagamuchira huwandu hwevanhu vakawanda kana kuongorora mishonga yemishonga mitsva yakagamuchirwa .

Kushandiswa kweKushandisa Zvinodhaka Kwemishonga

Kune marudzi maviri ezvinyorwa zvekushandiswa kwemutsa. Izvi zvinosanganisira:

• Emergency Use - Mamiriro ekukurumidzira chikumbiro chinogona kuitwa nefoni (kana imwe nzira yakakurumidza yekukurukurirana) uye mukuru weDFA angapa mvumo pamusoro pefoni kuti atange kurapwa. Chiremba anochirapa anofanira kutevera ichi chirevo chekutaura nechinyorwa chakashandurwa chekushandisa zvinodhaka zvinoshandiswa mumaminitsi gumi nemashanu kubva pamubvumirano weDWA wokushandisa mushonga. (Kana pasina nguva yakakwana yekuwana chibvumirano kubva kumapurisa ekuongorora mapepa (IRB) mumamiriro ezvinhu akaoma, kurapwa kunogona kutanga pasina kubvumirwa neRRB chero bedzi IRB ichiziviswa nachiremba anopa kurapwa kwekukurumidzira mukati mazuva mashanu ekushanda.)
• Kushandisa Netsitsi (Kusarwara Mumiririri Mumwe Chete) - Kunze kwekunge kune ngozi inopisa upenyu, chiremba anorapa anofanira kupedza tsvakurudzo itsva yekushandisa zvinoshandiswa zvinodhaka. Kana izvi zvichisvitsa FDA, FDA ine mazuva makumi matatu emakore apo chirongwa chacho chinogona kuongororwa uye chisarudzo chakaitwa sekugamuchirwa kana kuramba. Ramba uchifunga kuti nguva yakawanda yenguva, chisarudzo chichagoverwa pamwe nechiremba kurapa nekukurumidza.

(Sezvo ruzivo urwu ruchishandura nenguva, chengetedza mafungiro eDFA akanyorwa pasi pechikamu chino nokuda kwemashoko makuru-kusvika-zuva.)

Zvamunoda Kuziva Sokushivirira

Pane zvinhu zvakasiyana siyana zvekuchengeta mupfungwa kana uri kufunga nezvekushandisa kwekutsvaga zvinodhaka. Izvi zvinosanganisira:

• Chirwere (kana kuti chirongwa) chinogona kuva nematambudziko makuru.
• Sezvo mishonga (kana kuti chirongwa) ichigere kugamuchirwa neRDA, hazvizivikanwe kana mushonga wekutsvakurudza uri nani pane kana kuti wakaipa kudarika mishonga yemishonga. Iwe haungagamuchiri chimwe chekuwedzera kubatsiro kubva pamushonga.
• Iyo migumisiro yemigumisiro yenguva pfupi uye nemigumisiro yakareba yemigumisiro yemishonga haisati yakanyatsozivikanwa.

Mutoro Wakochiremba wako muKushandisa Zvinodhaka Zvinodhaka

Paunenge uchikumbira kushandiswa kwemishonga ine tsitsi, ichava kurapa kwako oncologist (iyo iwe unozviona iwe nokuda kwekutarisira) uyo achave ane basa rekushandiswa, hutungamiri, uye zvinyorwa zvekurapa.

• Chiremba anorapa anofanira kuzadza sarudzo sezvinotsanangurwa pamusoro apa.
• Chiremba anorapa achava nechinangwa chekuisa chirongwa chekurapa uye kuratidza FDA nemushumo wemigumisiro yehutano, chidimbu, uye chero mimwe migumisiro.
• Chiremba anorapa ane basa rekuwana mishonga kubva kune mugadziri / mutevedzeri, uye kuverenga kune chero mishonga inosara mushure mekurapa kwaitwa.
• Chiremba anorapa anofanira kubvumirana kutarisa murwere mukurapa kwose, kutevera mirayiridzo yese nemabasa sezvaanotora mubasa remupiririri kune murwere uyu.

_Sources:

_{National Cancer Institute. Kusvika kune Investigational Drugs. Yashandurwa 08/04/09. https://www.cancer.gov/about-cancer/treatment/drugs/investigational-drug-access-fact-sheet}

_{US Food and Drug Administration (FDA). Expanded Access (Compassionate Use). Yashandurwa 02/09/16. http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20080392.htm}

_{US Food and Drug Administration (FDA). Expanded Access: Ruzivo rwevarwere. Kushandurwa 03/03/16. http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm}

_{US Food and Drug Administration (FDA). Expanded Access: Information for Physicians. Updated 12/15/15. http://www.fda.gov/NewsEvents/PublicHealthFocus/ZvatsvagaAccessCompassionateUse/ucm429624.htm}

_{US Food and Drug Administration (FDA). IDE Kutanga / Kuwedzerwa Kuwedzerwa. Yakavandudzwa 03/26/15. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice /InvestigationalDeviceExemptionIDE/ucm051345.htm}