Ucwaningo / izindawo / izilingo zomtholampilo / i-nctn

I-NCTN: Inethiwekhi Kazwelonke Yezilingo Zemitholampilo yeNCI

Bheka leli bheji ezinhlanganweni nasezikhungweni zeNethiwekhi ezibambe iqhaza. Kusho ukuthi banikezwe isibonelelo yiNational Cancer Institute (NCI) njengelungu leNCI National Clinical Trials Network (NCTN).

INational National Clinical Trials Network (NCTN) yeNCI iqoqo lezinhlangano nabahlengikazi abaxhumanisa futhi basekele izivivinyo zomtholampilo ezindaweni ezingaphezu kwezingu-2 200 e-United States, Canada kanye nasemazweni omhlaba. I-NCTN ihlinzeka ngengqalasizinda yokwelashwa okuxhaswe yi-NCI kanye nokuhlolwa okuyisisekelo okuthuthukile kwezithombe ukuze kuthuthukiswe izimpilo zabantu abanomdlavuza.

Izilingo zomtholampilo ze-NCTN zisiza ukusungula amazinga amasha okunakekelwa, kusetha isigaba sokwamukelwa kwemithi emisha yi-Food and Drug Administration, kuvivinye izindlela ezintsha zokwelashwa, futhi kuqinisekiswe ama-biomarkers amasha.

I-NCI yethule izilingo eziningi nge-NCTN, kufaka phakathi:

• I-ALCHEMIST: I-Adjuvant Lung Cancer Enrichment Marker Signer and Sequicing Trials

• I-DART: Ukuvinjelwa okubili kwe-Anti-CTLA-4 ne-Anti-PD-1 Ekuvivinyweni Kwezimila Ezingajwayelekile

• I-Lung-MAP: I-Phase II / III Biomarker-Driven Master Protocol Yokwelashwa Komugqa Wesibili wawo wonke umdlavuza wamaphaphu wesigaba esithuthukile

• I-NCI-MATCH: Ukuhlaziywa Kwemolekyuli Yokhetho Lwezokwelapha kubantu abadala abanomdlavuza osezingeni eliphakeme

• I-NCI-COG Pediatric MATCH: Ukuhlaziywa Kwemolekyuli Yokhetho Lwezokwelapha ezinganeni nasebekhulile abancane abanomdlavuza osezingeni eliphezulu

• I-NCI-NRG ALK Master Protocol: Isivivinyo esiqhutshwa yi-biomarker seziguli ze-NSCLC ezingaphathwa kahle ngaphambili ze-ALK-non-squamous

Amaqembu Enethiwekhi Nezingxenye Zawo Zokusekela

Isakhiwo senethiwekhi silungele ukuhlola izibalo eziningi zeziguli ukuthola labo abanezicubu ezibonisa izici zamangqamuzana ezibanika ithuba elihle lokuphendula ukwelashwa okusha, okubhekiswe kukho. Kwabodokotela neziguli zabo, imenyu yezivivinyo ezibalulekile itholakala kabanzi ezweni lonke, emadolobheni amakhulu nasemiphakathini emincane ngokufanayo. I-NCTN inikeza ukufinyelela kuzindlela ezinhle kakhulu ezitholakala eziningi zomdlavuza ovamile futhi, ngokuya ngokwengeziwe, ngisho nangomdlavuza ongavamile.

Ukwengamela kwe-NCTN-isakhiwo sayo senhlangano, uxhaso lwezimali, kanye nokuqondiswa kwamasu okusebenza kwesikhathi eside-kungaphansi kweKlinikhi Yezilingo kanye neKomiti Yokululeka Kocwaningo Lokuhumusha (i-CTAC). Leli komiti eleluleka lombuso lenziwe ngongoti bezilingo zemitholampilo, abamele imboni, nabameli beziguli abavela kulo lonke izwe futhi banikeza izincomo kumqondisi we-NCI.

Isakhiwo se-NCTN sifaka amaqembu amahlanu e-US Network kanye neCanada Collaborating Clinical Trials Network. Ubulungu emaqenjini e-NCTN ngamanye bususelwa kuzinqubo eziqondene neqembu ngalinye. Amasayithi angaba ngeqembu elingaphezu kwelilodwa, futhi ubulungu okungenani eqenjini elilodwa kuvumela isiza ukuthi libambe iqhaza ezivivinyweni eziholwa yinoma yiliphi iqembu le-NCTN abaphenyi babo abafanelekile kulo. Ngenxa yalokho, abacwaningi abavela ku-LAPS, i-NCORP, ezinye izikhungo zemfundo, imikhuba yomphakathi, kanye namalungu aphesheya ahlotshaniswa namaqembu eNethiwekhi bonke bangabhalisa iziguli ezivivinyweni ze-NCTN. Ukuhlolwa komtholampilo okuholwa amaqembu e-NCTN kungathola ukwesekwa okuqhamuka e-IROC Group, ITSAs, nasemabhange ezicubu, ngokusho kwezidingo zesayensi zalezi zivivinyo.

Amaqembu Enethiwekhi

I-NCTN inamaqembu abantu abadala abane neqembu elilodwa elikhulu eligxile kuphela kumdlavuza wezingane. Lesi sakhiwo sifaka neCanadian Collaborating Clinical Trials Network. Amaqembu amahlanu e-US Network yile:

• I-Alliance for Clinical Trials ku-OncologyExit Disclaimer

• Iqembu le-ECOG-ACRIN Cancer Research GroupExit Disclaimer

• I-NRG OncologyExit Disclaimer

• Umshwana wokuzikhipha emthwalweni we-SWOGExit

• Iqembu Lezingane le-Oncology (COG) Phuma Disclaimer

Amaqembu ase-US ngalinye lixhaswa ngezindondo ezimbili ezihlukene — eyodwa ukuxhasa i-Network Operations kanti enye ukuxhasa iZikhungo Zezibalo Nezokuphathwa Kwedatha. Izikhungo Zokusebenza zinesibopho sokwenza imigomo emisha nokuphatha amakomidi ezomthetho, ezezimali, ubulungu namalungu esayensi eqembu ngalinye. Izikhungo zezibalo zibhekele ukuphathwa nokuhlaziywa kwedatha, ukulungiswa kombhalo wesandla, nokuqapha ukuphepha, ngaphezu kokusiza ekwakheni isivivinyo nasekuthuthukiseni.

I-Canadian Network Group ibambisana nama-US Network Groups lapho kwenziwa izivivinyo zomtholampilo ezikhethiwe, ezifika sekwedlule isikhathi, nezindawo eziningi. ICanada Network Group yile:

• ICanada Cancer Trials Group (CCTG) Exit Disclaimer

I-Network Operations and Statistical Centers yeqembu ngalinye le-NCTN zihlukene ngokwendawo kodwa zisebenza ngokubambisana. Zivame ukutholakala esikhungweni semfundo esinikeze "ukufaka" iqembu; kodwa-ke, ezimweni eziningana, isikhungo sisezindaweni ezizimele ezixhaswa ngezisekelo ezingenzi nzuzo. Okuwukuphela kokuhlukile kulokhu okungenhla yiCanada Collaborating Clinical Trials Network, eyathola umklomelo owodwa weSikhungo Sokusebenza kanye Nezibalo zayo.

Amasayithi Okubambaqhaza Ezemfundo (LAPS)

Izikhungo ezingamashumi amathathu nambili zemfundo yase-US ziklonyelisiwe ngesibonelelo se-Lead Academic Participating Site (LAPS), okuwumthombo wemali eyenzelwe ikakhulukazi i-NCTN. Lezi zindawo yizikhungo zokucwaninga ngezifundo nezinhlelo zokuqeqesha ubudlelwano, futhi iningi lemiklomelo yizikhungo zomdlavuza ezikhethiwe ze-NCI. Ukwemukela le miklomelo, amasayithi bekufanele akhombise amandla abo okubhalisa izinombolo eziphezulu zeziguli ezivivinyweni ze-NCTN, kanye nobuholi besayensi ekwakhiweni nasekuziphatheni kwezivivinyo zomtholampilo.

Abanikeli be-LAPS abangama-32 yibo:

I-Case Western Reserve University - Isikhungo Esiphelele Somdlavuza Icala iDana Farber / Isikhungo Somdlavuza saseHarvard

I-Duke Cancer Institute eDuke University Medical Center

I-Emory University - Isikhungo Somdlavuza Wokuwina

Isikhungo Sokucwaninga Ngomdlavuza kaFred Hutchinson

IJohns Hopkins University - Isikhungo Somdlavuza Esiphelele SikaSidney Kimmel

Isikhungo Somdlavuza WaseMayo Clinic

Ikholeji Yezokwelapha yaseWisconsin

Isikhungo Somdlavuza Se-Memorial Sloan Kettering

Isikhungo Somdlavuza Wokotini iNorris eDartmouth Hitchcock Medical Center

INorthwestern University - Isikhungo Somdlavuza Esiphelele SikaRobert H. Lurie

Isikhungo Somdlavuza Esiphelele sase-Ohio State University

Isikhungo Somdlavuza waseRoswell Park

Sidney Kimmel Cancer Centre eJefferson Health

Inyuvesi yase-Alabama eBirmingham

Isikhungo Somdlavuza Esiphelele Se-University of California Davis

Isikhungo Somdlavuza Esiphelele Se-University of Chicago

Isikhungo Somdlavuza saseYunivesithi yaseColorado

Isikhungo Somdlavuza Esiphelele sase-University of Michigan

Isikhungo Somdlavuza Esiphelele sase-University of North Carolina Lineberger

I-University of Oklahoma - Isikhungo Somdlavuza SikaStephenson

Inyuvesi yasePittsburgh Cancer Institute

Inyuvesi yaseRochester Wilmot Cancer Institute

I-University of Southern California - Isikhungo Somdlavuza Esiphelele SeNorris

Isikhungo Somdlavuza sase-University of Texas MD Anderson

Isikhungo Sezokwelapha sase-University of Texas Southwestern - Isikhungo Somdlavuza uHarold C. Simmons

I-University of Utah - iHuntsman Cancer Institute

Isikhungo se-University of Wisconsin Carbone Cancer

IVanderbilt University Medical Center - Isikhungo Somdlavuza saseVanderbilt Ingram

IWashington University eSt. Louis - Siteman Cancer Center

IWayne State University uBarbara Ann Karmanos Cancer Institute

IYale University - Isikhungo Somdlavuza saseYale

Amazinga aphezulu okubhaliswa kweziguli adinga izinga eliqhubekayo lomsebenzi wokuphathwa kwedatha eminyakeni eminingana, futhi izibonelelo ze-LAPS zisekela abasebenzi bezocwaningo abadingekayo ukuphatha lo mzamo. Izimali ezinikezwe kwizibonelelo ze-LAPS ukumboza lo msebenzi owandisiwe zikhuphula kahle izinga lokubuyiselwa kwesiguli ngasinye ezindaweni ezikhethiwe.

Imiklomelo ye-LAPS iphinde inikeze ngemali ethize yabaholi besayensi nabezokuphatha kuleyo ndawo uqobo lwayo, njengoba abaphenyi abayinhloko kuleyo ndawo badinga ukubeka phambili izivivinyo zokwelashwa ababamba iqhaza kuzo, futhi bafundise futhi baqeqeshe abasebenzi ezindaweni zokucwaninga ngemitholampilo futhi bathuthukise amasu okukhuthaza ukubhaliswa kweziguli.

Izibhedlela Zomphakathi Nezikhungo Zezokwelapha

Abanye abaphenyi abaningi ezibhedlela zomphakathi nasezikhungweni zezokwelapha bangabamba iqhaza ezivivinyweni ze-NCTN, noma ngabe basezindaweni ezingazange zithole umklomelo we-LAPS. Lawa masayithi, kanye nezindawo eziningi zamazwe omhlaba, zithola ukubuyiselwa kwemali ocwaningweni ngqo kusuka kwelinye lamaqembu enethiwekhi axhumene nawo noma athola imiklomelo evela kuhlelo lwe-NCI Community Oncology Research Program (NCORP).

Ubulungu besiza emaqenjini e-NCTN ngamanye bususelwa kunqubo ebekelwe iqembu ngalinye. Amasayithi aqhuba izivivinyo zemitholampilo angaba ngaphezu kweqembu elilodwa, futhi ubulungu okungenani eqenjini elilodwa kuvumela isiza ukuthi libambe iqhaza ezivivinyweni eziholwa yinoma yiliphi iqembu le-NCTN abaphenyi babo abakulungele. Ngenxa yalokho, abacwaningi abavela ku-LAPS, i-NCORP, ezinye izikhungo zemfundo, imikhuba yomphakathi, kanye namalungu aphesheya ahlotshaniswa namaqembu eNethiwekhi angabhalisa zonke iziguli ezivivinyweni ze-NCTN.

Ukufanekisa Ne-Radiation Oncology Core Group (IROC)

Ukusiza ukuqapha nokuqinisekisa ikhwalithi ezivivinyweni ezibandakanya izindlela ezintsha zokucabanga kanye / noma ukwelashwa ngemisebe, i-NCTN isungule i-Imaging and Radiation Oncology Core (IROC) GroupExit Disclaimer esiza wonke amaqembu e-NCTN asebenzisa lezi zindlela ezivivinyweni zawo.

Imiklomelo Yesayensi Ehlanganisiwe Yokuhumusha (ITSA)

Ingxenye yokugcina ye-NCTN yi-Integrated Translational Science Awards (ITSAs). Izikhungo eziyisihlanu zemfundo ezathola ama-ITSA zifaka phakathi amaqembu ososayensi abaguquguqukayo abasebenzisa ubuchwepheshe obusha bezakhi zofuzo, i-proteomic, ne-imaging ukusiza ukukhomba nokuthola amandla ama-biomarkers angaphambili okuphendula ekwelashweni amaqembu ezinethiwekhi angawafaka ezivivinyweni zokwelashwa ezizayo.

Le miklomelo isetshenziselwa ukukhulisa umsebenzi osuvele uqhutshwa kulama laboratories alaba baphenyi, okuvame ukuxhaswa ingxenye yezinye izibonelelo ze-NCI, ngethemba lokuthi laba bacwaningi bazosiza amaqembu enethiwekhi ukuletha okutholwe okusha kwelabhoratri ezivivinyweni zokwelashwa. Lawa malebhu wonke asebenzisa ubuchwepheshe obunqenqemeni obunikeza ukuhlukaniswa okungcono kwezicubu futhi kusize ekuboneni izinguquko ku-biology ye-tumor ekuphenduleni ekwelashweni okungasiza ukuchaza ukuthi ukumelana nokwelashwa kungakhula kanjani.

Abanikeli be-ITSA yilaba:

Isibhedlela Sezingane SasePhiladelphiaPhuma Ukuzikhulula

I-Emory University - I-Winship Cancer InstituteExit Ukuzikhulula

Isikhungo Somdlavuza Se-Memorial Sloan KetchingExit Disclaimer

Isikhungo Somdlavuza Esiphelele sase-Ohio State UniversityExit Disclaimer

I-University of North Carolina Lineberger Isikhungo Somdlavuza EsipheleleExit Disclaimer

Amabhange Amathishu we-NCTN

Iqembu ngalinye le-NCTN futhi liqoqa futhi ligcine izicubu ezivela ezigulini ezivivinyweni ze-NCTN kwinethiwekhi ehambisanayo yamabhange wezicubu. Kwenziwe imigomo ejwayelekile ukuqinisekisa ukuthi izicubu eziqoqiwe zisezingeni eliphakeme kakhulu. Amarekhodi asekhompyutheni amasampula agciniwe anemininingwane ebalulekile yomtholampilo, njengezindlela zokwelashwa ezitholwa yiziguli okwathathwa kuzo izicubu, impendulo yokwelashwa, nomphumela wesiguli. Abahlanganyeli ezivivinyweni ze-NCTN bangavuma futhi ukusetshenziswa kwezinhlobonhlobo zezicubu zabo zezifundo ezingaphezu kwesivivinyo se-NCTN ababhalise kuzo. Uhlelo lwebhange le-NCTN lucubungula uhlelo olususelwa kuwebhu olungasetshenziswa noma yimuphi umcwaningi. Abaphenyi, kufaka phakathi labo abangahlangene ne-NCTN,

Amakomidi Obhekele Ezesayensi

Amaqembu e-NCTN aphakamisa imiqondo yezilingo ezintsha zomtholampilo kumaKomidi Ezifo Zezifo ze-NCI / Imaging Steering. Lawa makomidi ahlelwe yi-NCI ukuhlola nokubeka phambili izilingo ezintsha zomtholampilo futhi ancoma i-NCI labo okungenzeka babe nomthelela omkhulu wesayensi nomtholampilo. Ikomidi ngalinye liholwa ngoSihlalo abangabambisene nohulumeni abavunyelwe ukuba nezikhundla zobuholi emaqenjini e-NCTN, yize bengaba ngamalungu eqembu. Ubulungu obusele bekomiti buqukethe amalungu eqembu le-NCTN akhethwe yiqembu ngalinye, abanye ochwepheshe bezifo abangabandakanyeki ezikhundleni zobuholi emaqenjini, abamele i-SPORE exhaswa yi-NCI ne-Consortia, izazi ze-biostatisticians, abameli beziguli kanye nochwepheshe bezifo ze-NCI.

Isabelomali se-NCTN

Isabelomali esiphelele se-NCTN yi- $ 171 million, esatshalaliswa ezingxenyeni ezahlukahlukene zenethiwekhi. Lolu hlelo luhlinzeka ngokubhaliswa minyaka yonke kwabahlanganyeli ababalelwa ku-17,000-20,000 ekwelashweni komdlavuza nasekulingweni kwe-imaging.

Ukusebenza ngokubambisana

Amaqembu e-NCTN akwazi ukunciphisa izindleko zokwenza izivivinyo ngokwabelana ngezinsizakusebenza. Le ndlela yokubambisana ivumela amalungu eqembu elilodwa le-NCTN ukuthi asekele izivivinyo eziholwa ngamanye amaqembu futhi anikeze amalungu e-NCTN amandla okwenza iphothifoliyo ephelele yezilingo kumdlavuza ovame kakhulu.

Ngoba i-NCTN inamaqembu abantu abadala amane kuphela ase-US, anezikhungo ezimbalwa ze-Operations and Statistical Centers ezidinga ukwesekwa kwezezimali, kube khona ukonga kwezindleko. Wonke amaqembu asebenzisa uhlelo olujwayelekile lokuphathwa kwedatha (iMedidata Rave) nohlelo oluhlanganisiwe lwe-IT lwamabhange ezicubu, okuhumusha ukonga izindleko.

Ukusekelwa okungeziwe

Ukuhlolwa komtholampilo kuyizinto eziyinkimbinkimbi ezidinga inqwaba yezinhlangano ezisekelayo nemithombo yezimali. Inethiwekhi ifaka ezinye izici eziningi ezingafakwanga emiklomelweni ye-NCTN kepha ezibalulekile ekwenzeni inhloso ye-NCTN.

Ukusekelwa okungeziwe kufaka phakathi:

• Central Institutional Review Boards, ingxenye ebalulekile yohlelo lokuhlolwa komtholampilo lwe-NCI elengeza isivinini, ukusebenza kahle, kanye nokufana ekubuyekezweni kokuziphatha.

• I-Cancer Trials Support Unit (i-CTSU), inkontileka exhaswa yi-NCI enikeza abaphenyi bemitholampilo nabasebenzi babo ukufinyelela kokuma ku-inthanethi kokuhlolwa kwe-NCTN futhi kuvumela abaphenyi ukuthi babhalise iziguli ezintsha.

• Ibhange lezicubu elizinikele leqembu ngalinye leNethiwekhi lixhaswe ngomshini oklonyelisiwe we-NCI.

• Uhlelo lwe-Biomarker, Imaging, kanye neKhwalithi ye-Life Study Funding Programme (i-BIQSFP), ukusakazwa kwemali okuhlukile kwezilingo ze-NCTN ezisekela izifundo zesayensi ezihambelana nokuhlolwa kweqembu. Amaqembu e-NCTN ancintisana ngezimali ezigcinelwe unyaka ngamunye le nhloso. Ukutholakala kwezimali ezinikele kusiza kakhulu ukusebenzisana, njengoba izivivinyo zokwelashwa kufanele zihlangabezane nezikhathi ezinzima.

• Ngaphezu kwalokho, cishe ikota eyodwa yokuqoqwa kwesiguli ezivivinyweni zokwelashwa ze-NCTN ikhokhelwa uhlelo lwe-NCORP. Izibhedlela zomphakathi nezikhungo zezokwelapha ezibambe iqhaza ohlelweni lwe-NCORP zibuyiselwa imali yokuqongelela iziguli ezivivinyweni zokwelashwa ze-NCTN ngemiklomelo yazo ye-NCORP, hhayi ngomklomelo we-NCTN Group Operations.

Okokugcina, ngaphezu kwalezizindleko ezinkulu zaminyaka yonke, i-NCI ibuye ixhase i-NCTN ngokukhokhela eminye imisebenzi eminingi yokuhlolwa komtholampilo ebalulekile, ngaleyo ndlela iqhubeke nokunciphisa izindleko ezithwalwa amaqembu e-Network:

• I-NCI ikhokhela amalayisense nezimali zokubamba zohlelo lwe-elekthronikhi, olujwayelekile lokuphathwa kwedatha, olubizwa ngeMedidata Rave, olusetshenziswa yiwo wonke amaqembu e-NCTN.

• I-NCI yengamela uhlelo lokucwaningwa kwamabhuku lukazwelonke lwezivivinyo ze-NCTN.

• I-NCI iphatha izicelo zezidakamizwa ezintsha ze-Investigational ku-Food and Drug Administration kanye nokusatshalaliswa kwale mithi ezilingweni eziningi ze-NCTN.

Ukusebenzisana phakathi kwamaqembu kubhekwa njengokusemqoka empumelelweni kuwo wonke amazinga enhlangano futhi manje sekuvuzwa ngokukhethekile ngesikhathi sokubuyekezwa kwesibonelelo. Ukusebenza kahle kuyacindezelwa, futhi nezikhathi ezibekiwe eziyimpoqo manje sezikhona ukuze kuthuthukiswe umthetho olandelwayo. Yize lezi zinguquko zibhekwa njengezibalulekile empilweni yohlelo lukahulumeni, futhi ziza ngesikhathi esifanele, ngoba izinguquko ezijabulisayo kusayensi ye-oncologic zinikela ngezindlela ezintsha zokuthuthuka okusheshayo, ikakhulukazi ekwakhiweni kwezindlela ezintsha zokwelapha.