Kutsvaga / nzvimbo / kiriniki-miedzo / nctn

NCTN: NCI yeNational Clinical Miedzo Network

Tarisa bheji iri mukutora chikamu Masangano nemasangano. Zvinoreva kuti vakapihwa rubatsiro neNational Cancer Institute (NCI) senhengo yeNCI National Clinical Trials Network (NCTN).

NCI yeNational Clinical Trials Network (NCTN) muunganidzwa wemasangano uye varapi vanobatanidza uye vanotsigira kenza kiriniki miedzo munzvimbo dzinopfuura zviuru zviviri nemazana maviri muUnited States, Canada, nepasirese. NCTN inopa zvivakwa zveNCI-yakabhadharwa kurapwa uye ekutanga epamhando ekuyedza miedzo yekuvandudza hupenyu hwevanhu vane gomarara.

NCTN kiriniki miedzo inobatsira kumisikidza mitezo mitsva yekutarisira, kuseta danho rekubvumidzwa kwemarapirwo matsva neKudya neDrug Administration, kuyedza nzira nyowani dzekurapa, uye kugonesa matsva matsva.

NCI yakatanga miedzo yakati wandei kuburikidza neNCTN, inosanganisira:

• ALCHEMIST: Adjuvant Lung Cancer Inosimudzira Mucherechedzo Kuzivikanwa uye Kuenzanisira Miedzo

• DART: Dual Anti-CTLA-4 uye Anti-PD-1 Kuvharirwa muRare Tumors Trial

• Lung-MAP: Phase II / III Biomarker-Inotungamirwa Master Protocol yeChipiri Mutsetse Therapy kune ese Akafambiswa Stage Asiri-Madiki Maseru Emaperembudzi.

• NCI-MATCH: Molecular Analysis ye Therapy Sarudzo yevakuru vane kenza dzepamberi

• NCI-COG Pediatric MATCH: Molecular Analysis ye Therapy Sarudzo yevana nevakuru vechidiki vane cancer yepamusoro

• NCI-NRG ALK Master Protocol: Muedzo unofambiswa nebiomarker kune vakamborapwa ALK-positive asiri-squamous NSCLC varwere

Network Mapoka uye Tsigiro Yavo Zvikamu

Sangano rehurongwa hwehurongwa rakanakira kuongorora huwandu hukuru hwevarwere kuti vawane avo vane mamota anoratidzira mamorekuru maficha anovapa iwo mukana wakanaka kwazvo wekupindura kurapwa kutsva, kwakanangwa. Kune varapi nevarwere vavo, menyu yemiedzo yakakosha inowanikwa zvakanyanya munyika yese, mumaguta makuru nenzvimbo diki zvakafanana. NCTN inopa mukana weakanakisa nzira anowanikwa kune mazhinji akajairwa uye, achiwedzera, kunyangwe kenza isingawanzo.

Kutarisisa kweNCTN - chimiro chayo chesangano, mari, uye nzira yenguva refu - iri pasi pekutarisirwa kweKiriniki Yekutongwa uye Dudziro Yekutsvagisa Adhivhosi Komiti (CTAC). Dare redzimhosva rezvemubatanidzwa rinoumbwa nemakiriniki ekuyedza nyanzvi, vamiririri veindasitiri, nevatsigiri vevarwere vanobva kurudzi rwese uye vanopa kurudziro kumutungamiriri weNCI.

Chimiro cheNCTN chinosanganisira mashanu eUS Network mapoka uye neCanada Kubatana Clinical Trials Network. Nhengo mumapoka ega eNCTN anoenderana nematanho akanangana neboka rega rega. Nzvimbo dzinogona kuve dzeanopfuura rimwe boka, uye kuve nhengo mune rimwe chete boka kunotendera saiti kutora chikamu mumiedzo inotungamirwa neboka chero reNCTN iro vanotsvaga avo vanokodzera. Nekudaro, vaongorori vanobva kuLAPS, NCORP, mamwe masosi ezvidzidzo, maitiro enharaunda, uye nhengo dzepasirese dzakabatana nemapoka eNetwork vese vanogona kunyoresa varwere kumiedzo yeNCTN. Zvemakiriniki miedzo inotungamirwa nemapoka eNCTN anogona kuwana rutsigiro kubva kuIROC Boka, ITSAs, uye mabhanga enyama, zvinoenderana nezvinodiwa nesainzi zvemiyedzo.

Network Mapoka

Iyo NCTN inoumbwa nemapoka evakuru mana uye rimwe boka hombe rinotarisana chete nekenza dzevacheche. Icho chimiro chinosanganisira zvakare yeCanada Kubatana Clinical Miedzo Network. Iwo mashanu eUS Network Mapoka ari:

• Kubatana kweMakiriniki Miedzo muOncologyExit Disiki

• ECOG-ACRIN Cancer Yekutsvagisa BokaExit Disiki

• NRG OncologyExit Disiki

• SWOGExit Disiki

• Yevana Oncology Boka (COG) Buda Disclaimer

Iwo mapoka eU.S. anopihwa mari kuburikidza nemimwe mibairo miviri — imwe yekutsigira Network Operations uye imwe kutsigira Statistics neData Management Centres. Iwo maOperation Centers ane basa rekuvandudza marongero matsva uye nekugadzirisa emitemo, emari, nhengo uye makomiti esainzi eboka rega rega. Iwo Statistical Centers ane basa rekutungamira kwedata uye ongororo, gadziriso yemanyoro, uye kuongorora kwekuchengetedza, mukuwedzera pakubatsira mukuyera dhizaini nekusimudzira.

ICanada Network Group inobatana neUS Network Mapoka mukuitisa kwesarudzo, yekupedzisira-chikamu, yakawanda-saiti kiriniki miedzo. Iyo Canada Network Boka iri:

• Canada Cancer Miedzo Boka (CCTG) Buda Disclaimer

Iyo Network Operations uye Statistical Centers yeboka rega rega reNCTN akapatsanurwa munzvimbo asi anoshanda pamwe chete. Ivo vanowanzo kuve panzvimbo yekudzidzira iyo yakapa ku "imba" boka; zvisinei, muzviitiko zvakati wandei, nzvimbo inowanikwa panzvimbo yakasununguka inobhadharwa kuburikidza nenheyo isingabatsiri. Kunze kwekusara kune pamusoro apa ndeyeCanada Kubatana Clinical Trials Network, iyo yakagashira mubairo mumwe chete weYake Operations uye Statistical Center.

Tungamira Nzvimbo Dzinotora Chikamu Dzinotora Chikamu (LAPS)

Makumi matatu nemaviri masangano ekudzidzira eUS akapihwa rubatsiro rweMutungamiri weChikamu Chekutora Chikamu (LAPS), inova sosi yemari yakagadzirirwa kunyanya iyo NCTN. Iwo masosi masosi ekutsvagisa ezvidzidzo nemapurogiramu ekuyanana, uye mazhinji emakopi ari NCI-Yakatemerwa Cancer Centers. Kuti vagamuchire mibairo iyi, nzvimbo dzaifanirwa kuratidza kugona kwavo kunyoresa huwandu hwevarwere kumiedzo yeNCTN, pamwe nehutungamiriri hwesainzi mukugadzirwa uye kuitiswa kwemiedzo yekiriniki.

Iwo 32 maLAPS vanopihwa ndeaya:

Case Western Western University - Nyaya Yakakwana Cancer Center Dana Farber / Harvard Cancer Center

Duke Cancer Institute kuDuke University Medical Center

Emory University - Winship Kenza Institute

Fred Hutchinson Cancer Yekutsvagisa Center

Johns Hopkins University - Sidney Kimmel Yakakwana Cancer Center

Mayo Clinic Kanzera Center

Chiremba Koreji yeWisconsin

Chirangaridzo Sloan Kettering Cancer Center

Norris Cotton Cancer Center kuDartmouth Hitchcock Medical Center

Northwestern University - Robert H. Lurie Comprehensive Cancer Center

Ohio State University Yakakwana Cancer Center

Roswell Park Cancer Institute

Sidney Kimmel Cancer Center paJefferson Health

Yunivhesiti yeAlabama kuBirmingham

Yunivhesiti yeCalifornia Davis Yakakwana Cancer Center

Yunivhesiti yeChicago Yakakwana Cancer Center

Yunivhesiti yeColorado Cancer Center

Yunivhesiti yeMichigan Yakakwana Cancer Center

Yunivhesiti yeNorth Carolina Lineberger Yakakwana Cancer Center

Yunivhesiti ye Oklahoma - Stephenson Cancer Center

Yunivhesiti yePittsburgh Cancer Institute

Yunivhesiti yeRochester Wilmot Cancer Institute

Yunivhesiti yeSouth California - Norris Yakakwana Cancer Center

Yunivhesiti yeTexas MD Anderson Cancer Center

Yunivhesiti yeTexas Southwestern Medical Center - Harold C. Simmons Cancer Center

Yunivhesiti yeUtah - Huntsman Cancer Institute

Yunivhesiti yeWisconsin Carbone Cancer Center

Vanderbilt University Medical Center - Vanderbilt Ingram Cancer Center

Washington University kuSt. Louis - Siteman Cancer Center

Wayne State University Barbara Ann Karmanos Cancer Institute

Yale Yunivhesiti - Yale Cancer Center

Matunhu epamusoro ekunyoreswa kwevarwere anoda danho rakatsiga rekuchengetedza dhata basa kwemakore akati wandei, uye zvipo zveLAPS zvinotsigira vatsvagiridzi vanodiwa kuti vaite izvi. Mari dzakapihwa muzvipo zveLAPS kufukidza uyu wakawanda mutoro webasa zvinonyatso simudza mwero wemuripo-murwere kunzvimbo dzakasarudzwa.

Iyo mibairo yeLAPS inopawo imwe mari yehutungamiriri nesainzi hutungamiriri panzvimbo yacho pachayo, sevatsvagiridzi vakuru panzvimbo iyi vanofanirwa kukoshesa miedzo yekiriniki mavanotora chinzvimbo, pamwe nekudzidzisa uye kudzidzisa vashandi panzvimbo dzekutsvaga pakiriniki nekuvandudza. mazano ekusimudzira kunyoresa kwevarwere.

Zvipatara Zvemunharaunda uye Zvipatara

Vamwe vazhinji vaongorori kuzvipatara zvemunharaunda nenzvimbo dzekurapa vanogona kutora chikamu mumiedzo yeNCTN, kunyangwe kana vari kunzvimbo dzisina kupihwa mubairo weLAPS. Aya masayiti, pamwe nenzvimbo dzinoverengeka dzenzvimbo dzepasi rose, dzinogashira mari yekutsvagisa yakanangana kubva kune rimwe remapoka enetiweki aakabatana nawo kana vanogamuchira mibairo kubva kuNCI Nharaunda Oncology Research Chirongwa (NCORP).

Siti yenhengo mune yega NCTN mapoka akavakirwa pane zvirevo zvakanangana neboka rega rega. Masayiti ari kuitisa kiriniki miedzo anogona kuve eboka rinopfuura rimwe, uye kuve nhengo mune rimwe chete boka kunotendera saiti kutora chikamu mumiedzo inotungamirwa neboka chero reNCTN iro vanotsvaga avo vanokodzera. Nekudaro, vaongorori vanobva kuLAPS, NCORP, mamwe masosi ezvidzidzo, maitiro enharaunda, uye nhengo dzepasirese dzakabatana nemapoka eNetwork vese vanogona kunyoresa varwere mumiedzo yeNCTN.

Kufungidzira uye Radiation Oncology Core Boka (IROC)

Kubatsira kuongorora uye kuona mhando mumiedzo inosanganisira hutsva hwekufungidzira uye / kana radiation radiation, NCTN yakagadzira Imaging uye Radiation Oncology Core (IROC) GroupExit Disclaimer iyo inobatsira ese mapoka eNCTN anoshandisa nzira idzi mumiedzo yavo.

Yakabatanidzwa Dudziro Sayenzi Mubairo (ITSA)

Chikamu chekupedzisira cheNCTN ndiwo Akabatanidzwa Ekushandura Sayenzi Mubairo (ITSAs). Masangano mashanu ezvidzidzo akagamuchira ITSA anosanganisira zvikwata zvevasayendisiti vanoshandura vanoshandisa hunyanzvi hwekugadzira, maumbirwo, uye matekinoroji ekufungidzira kubatsira kuziva nekukwanisa kungofungidzira mabiomarkers ekupindura kurapwa uko mapoka eneti anogona kupinza mumayedzo emakiriniki mune ramangwana.

Iyi mibairo inoshandiswa kuwedzera basa rave kutoitika mumarabhoritari evaongorori, anowanzo tsigirwa muchikamu nemamwe mabhenefiti eNCI, netarisiro yekuti vaongorori ava vachabatsira mapoka enetiweki kuti aunze zvitsva marabhoritari mumakiriniki ekuedzwa. Aya marabhabhu ese anoshandisa ekucheka-kumucheto matekinoroji ayo anogonesa zvirinani kuratidzwa kwemamota uye anobatsira kuona shanduko mune bundu biology mukupindura kurapwa kunogona kubatsira kutsanangura marapirwo ekuramba kurapa.

Vaya vanopa ITSA ndeaya:

Chipatara chevana chePhiladelphia Buda Disiki

Emory University - Winship Cancer InstituteExit Disclaimer

Chirangaridzo Sloan Kettering Cancer CenterBuda Disiki

Ohio State University Yakakwana Cancer CenterBuda Disiki

Yunivhesiti yeNorth Carolina Lineberger Yakakwana Cancer CenterExit Disclaimer

NCTN Tissue Mabhangi

Boka rega rega reNCTN rinounganidza uye rinochengeta zvinyama kubva kuvarwere muNCTN miedzo mune inoenderana netiweki yemabhangi echinyama. Maitiro akajairwa akagadzirwa kuona kuti nyama inounganidzwa ndeyemhando yepamusoro. Makomputa marekodhi emasampuli akachengetedzwa ane zvakakosha zvemakiriniki, senge marapirwo akagamuchirwa nevarwere kwakatorwa huturu, mhinduro yekurapwa, uye mhedzisiro yemurwere. Vatori vechikamu mumiedzo yeNCTN vanogonawo kubvumidza kushandiswa kwavo kwemhando dzemhando dzezvidzidzo kupfuura kwekuedzwa kweNCTN kwavakanyoresa. Iyo NCTN tishu bank chirongwa inosanganisira iyo web-based system iyo chero muongorori anogona kushandisa. Vatsvagiri, kusanganisira avo vasina hukama neNCTN,

MaSainzi Ekutarisa Makomiti

Mapoka eNCTN anopa pfungwa dzemayedzo matsva emakiriniki kuNCI Disease / Imaging Steering Committe. Aya makomiti akarongedzwa neNCI kuti aongorore nekuisa pamberi pekutanga miedzo yemakiriniki uye nekukurudzira kuNCI avo vangangodaro vane yakanyanya kunaka yesainzi uye yekiriniki mhedzisiro. Dare rega rega rinotungamirwa nemasachigaro ehurumende asiri ehurumende vasingatenderwe kubata zvigaro zvehutungamiriri mumapoka eNCTN, kunyangwe vachigona kuve nhengo dzeboka. Iyo yasara yenhengo yekomiti inoumbwa nenhengo dzeboka reNCTN dzakasarudzwa neboka rega rega, dzimwe nyanzvi dzezvirwere dzisingabatanidzwe munzvimbo dzehutungamiriri mumapoka, vamiririri veNCORE-yakapihwa mari yeSSPORE neConsortia, biostatisticians, vatsigiri vevarwere, uye nyanzvi dzezvirwere zveNCI.

NCTN Budget

Yakazara NCTN bhajeti iri $ 171 mamirioni, akagoverwa kune akasiyana zvikamu zve netiweki. Iyi sisitimu inopa kunyoresa kwegore rose kwevangangoita 17,000-20,000 vatori vechikamu pakurapwa kwegomarara uye kuyedza kwekufungidzira

Kubudirira mukubatana

Mapoka eNCTN anokwanisa kudzikisa mutengo wekuitisa miedzo nekugovana zviwanikwa. Iyi nzira yekudyidzana inobvumidza nhengo dzeimwe boka reNCTN kutsigira miedzo inotungamirwa nemamwe mapoka uye inopa nhengo dzeNCTN kugona kuitisa yakazara portfolio yemiedzo mukenza dzinowanzozivikanwa.

Nekuti iyo NCTN ine chete mana evakuru mapoka eUS, iine mashoma Mashandiro uye Statistical Centers inoda rutsigiro rwemari, kwave kune mari yemutengo yekuchengetedza. Ese emapoka anoshandisa yakajairika dhata manejimendi system (Medidata Rave) uye yakasanganiswa IT system yemabhangi enyama, ayo anoshandura mukuchengetedza mutengo.

Kuwedzera Kutsigira

Zvemakiriniki miedzo zviitiko zvakaoma izvo zvinoda kuwanda kwemasangano ekutsigira uye hova dzemari. Iyo network inosanganisira zvimwe zvinoverengeka zvisina kubatanidzwa muNCTN mibairo asi izvo zvakakosha kuita basa reNCTN.

Rumwe rutsigiro rwunosanganisira:

• Central Institutional Ongororo Mabhodhi, chinhu chakakosha cheNCI's kiriniki yekuyedza system iyo inowedzera kumhanya, kugona, uye kufanana kune kuongororwa kwetsika.

• Cancer Trials Support Unit (CTSU), chibvumirano chakapihwa mari neNCI chinopa vanoongorora zvemakiriniki uye nevashandi vavo mukana wekumira pamhepo kumiedzo yeNCTN uye inobvumira vaongorori kunyoresa varwere vatsva.

• Bhengi rakazvipira reboka rega rega reNetwork rakabhadharwa kuburikidza neakasiyana NCI mubairo mashandiro.

• Iyo Biomarker, Kufananidzira, uye Hwakanaka hweHupenyu Zvidzidzo Zvekubhadharira Chirongwa (BIQSFP), yakasarudzika mari yekutsvagisa kweNCTN miedzo inotsigira inoenderana yesainzi zvidzidzo pamiedzo yeboka. Mapoka eNCTN anokwikwidzana nemari dzinonyatso chengetwa gore rega nekuda kwechinangwa ichi. Kuwanikwa kwemari dzakatsaurwa kunobatsira kwazvo kubatana, sezvo miedzo yekiriniki inofanirwa kusangana nenguva dzakaomarara.

• Uye zvakare, ingangoita kota yechirwere chevarwere paNCTN kurapwa miedzo inobhadharwa nechirongwa cheNCORP. Zvipatara zvemunharaunda uye nzvimbo dzekurapa dzinotora chikamu muchirongwa cheNCORP dzinodzoreredzwa kuunganidzira varwere kuNCTN kurapwa miedzo nemubairo wavo weNCORP, kwete kuburikidza nemubhadharo weNCTN Group Operations.

Finally, in addition to these substantial annual expenditures, NCI also subsidizes the NCTN by paying for many other essential clinical trial functions, thereby further reducing costs borne by the Network groups:

• NCI pays for the licenses and hosting fees of the electronic, common data management system, called Medidata Rave, used by all of the NCTN groups.

• NCI oversees a national audit system for NCTN trials.

• NCI manages Investigational New Drug applications to the Food and Drug Administration along with the distribution of these drugs for many NCTN trials.

Kubatana pakati pemapoka kunoonekwa sekukosha pakubudirira pamatanho ese esangano uye iko zvino kwakapihwa mubairo panguva yekuwongorora rubatsiro. Kubudirira kunosimbiswazve, uye nguva dzekumanikidzwa dzave munzvimbo yekuvandudza protocol. Kunyangwe shanduko idzi dzichionekwa sedzakakosha pahutano hweveruzhinji system, dzinouyawo panguva yakafanira, nekuti shanduko dzinonakidza musainzi yemakemikari dziri kupa nzira nyowani dzekufambira mberi nekukurumidza, kunyanya kusimudzira kwetsva marapirwo.