Kafukufuku / madera / mayesero azachipatala / nctn

NCTN: Network ya National Clinical Trials Network ya NCI

Fufuzani baji iyi m'mabungwe ndi mabungwe omwe akutenga nawo mbali. Zikutanthauza kuti apatsidwa thandizo ndi National Cancer Institute (NCI) ngati membala wa NCI National Clinical Trials Network (NCTN).

NCI's National Clinical Trials Network (NCTN) ndi gulu la mabungwe ndi asing'anga omwe amayang'anira ndikuthandizira mayesero azachipatala m'malo opitilira 2,200 ku United States, Canada, ndi mayiko akunja. NCTN imapereka njira zothandizira kuchipatala komwe kumathandizidwa ndi NCI komanso mayeso oyambira apamwamba kuti atukule miyoyo ya anthu omwe ali ndi khansa.

Mayesero azachipatala a NCTN amathandizira kukhazikitsa miyezo yatsopano ya chisamaliro, kukhazikitsa njira yovomerezera njira zatsopano zamankhwala ndi Food and Drug Administration, kuyesa njira zatsopano zamankhwala, ndikutsimikizira ma biomarkers atsopano.

NCI yakhazikitsa mayesero angapo kudzera mu NCTN, kuphatikiza:

• ALCHEMIST: Kuzindikira Chizindikiro Cha Khansa Yam'mapapo Am'mayeso ndi Kuyesa Kuyesa

• DART: Dual Anti-CTLA-4 ndi Anti-PD-1 Kutsekedwa M'mayeso Omwe Amakonda Kutupa

• Lung-MAP: Phase II / III Biomarker-Driven Master Protocol yachiwiri Line Therapy ya onse Khansa Yapafupifupi Yopanda Magulu Amatenda

• NCI-MATCH: Kusanthula kwa Maselo a Therapy Kusankha kwa achikulire omwe ali ndi khansa yayikulu

• NCI-COG Matenda a Ana: Kusanthula kwama Molecular Therapy Kusankha kwa ana ndi achikulire omwe ali ndi khansa yayikulu

• NCI-NRG ALK Master Protocol: Chiyeso choyendetsedwa ndi biomarker kwa odwala omwe anali ndi vuto la ALK omwe sanali a squamous NSCLC

Magulu A Network ndi Zothandizira Zawo

Kapangidwe ka netiweki ndi koyenera kuwunika odwala ambiri kuti apeze omwe zotupa zawo zimawonetsa mawonekedwe am'magazi omwe amawapatsa mwayi woyankha kuchipatala chatsopano. Kwa asing'anga ndi odwala awo, mndandanda wa mayesero ofunikira amapezeka mdziko lonselo, m'mizinda ikuluikulu komanso midzi ing'onoing'ono chimodzimodzi. NCTN imapereka mwayi wopezeka m'njira zabwino kwambiri za khansa zomwe sizachilendo.

Kuyang'anira NCTN - kapangidwe kake ka bungwe, ndalama, komanso kuwongolera kwakanthawi kwakanthawi - zikuyang'aniridwa ndi Clinical Trials and Translational Research Advisory Committee (CTAC). Komiti iyi yolangiza boma ili ndi akatswiri azoyeserera zamankhwala, oyimira mafakitale, ndi othandizira odwala kudera lonselo ndikupereka malingaliro kwa director wa NCI.

Kapangidwe ka NCTN kali ndi magulu asanu a US Network ndi Canada Collaborating Clinical Trials Network. Umembala m'magulu amtundu wa NCTN umakhazikitsidwa potengera zomwe zili mgulu lililonse. Masamba atha kukhala opitilira gulu limodzi, ndipo kukhala mgulu limodzi kumalola kuti tsamba litenge nawo mbali pamayeso omwe amatsogozedwa ndi gulu lililonse la NCTN lomwe ofufuza awo ali oyenerera. Zotsatira zake, ofufuza ochokera ku LAPS, NCORP, malo ena ophunzirira, machitidwe ammudzi, ndi mamembala apadziko lonse lapansi omwe amagwirizana ndi magulu a Network atha kulembetsa odwala ku mayeso a NCTN. Mayesero azachipatala otsogozedwa ndi magulu a NCTN atha kulandira chithandizo kuchokera ku IROC Group, ITSAs, ndi mabanki amisempha, kutengera zosowa zasayansi zamayesowo.

Magulu A Network

NCTN imakhala ndimagulu anayi akuluakulu ndipo gulu limodzi lalikulu limangoyang'ana khansa yaubwana. Kapangidwe kake kamaphatikizaponso Canadian Collaborating Clinical Trials Network. Magulu asanu aku US Network ndi awa:

• Mgwirizano Wama Clinical Trials mu OncologyExit Disclaimer

• Gulu la Kafukufuku wa Khansa ya ECOG-ACRINChotsani Chodzikanira

• NRG OncologyExit Chodzikanira

• Chodzikanira

• Gulu la Ana la Oncology (COG) Tulukani Chodzikanira

Magulu aku US aliwonse amalandila ndalama kudzera mu mphotho ziwiri zosiyana — imodzi yothandizira Network Operations ndi ina yothandizira Statistics and Data Management Center. Maofesi a Opaleshoni ali ndi udindo wopanga malamulo atsopano ndikuwongolera mabungwe oyang'anira, azachuma, mamembala ndi asayansi a gulu lirilonse. Ma Statistical Centers ali ndiudindo woyang'anira kusanthula ndi kusanthula, kukonzekera zolemba pamanja, ndikuwunika chitetezo, kuphatikiza pakuthandizira pakupanga zoyeserera ndi chitukuko.

Canadian Network Group imagwirizana ndi US Network Groups pakuchita zoyeserera zamankhwala osankhidwa, mochedwa, komanso osiyanasiyana. Canadian Network Group ndi:

• Canadian Cancer Trials Group (CCTG) Chotsani Chodzikanira

Network Operations and Statistical Center za gulu lililonse la NCTN ndizosiyana koma zimagwirira ntchito limodzi. Nthawi zambiri amapezeka pamalo ophunzirira omwe adapereka "nyumba" ya gululo; komabe, kangapo, malo amakhala pamalo opumira omwe amalipiridwa ndi maziko osapindulitsa. Chokhacho kupatula pamwambapa ndi Canadian Collaborating Clinical Trials Network, yomwe idalandira mphotho imodzi ya Opaleshoni ndi Statistical Center.

Masamba Othandizira Ophunzira Maphunziro (LAPS)

Masukulu 32 aku US apatsidwa thandizo la Lead Academic Participating Site (LAPS), lomwe ndi gwero la ndalama zopangidwa makamaka ku NCTN. Malowa ndi malo ophunzirira maphunziro omwe ali ndi mapulogalamu ophunzirira kuyanjana, ndipo ambiri omwe apatsidwa mphotho ndi Malo Ophunzirira Khansa a NCI. Kuti alandire mphothozi, malowa amayenera kuwonetsa kuthekera kwawo kulembetsa odwala ambiri pamayeso a NCTN, komanso utsogoleri wa asayansi pakupanga ndikuyesa kwamayeso azachipatala.

Othandizira a 32 LAPS ndi awa:

Case Western Reserve University - Case Comprehensive Cancer Center Dana Farber / Harvard Cancer Center

Duke Cancer Institute ku Duke University Medical Center

Emory University - Institute ya Khansa ya Winship

Fred Hutchinson Kafukufuku wa Khansa

Yunivesite ya Johns Hopkins - Sidney Kimmel Comprehensive Cancer Center

Mayo Clinic Khansa Center

Medical College ya Wisconsin

Chikumbutso cha Sloan Kettering Cancer Center

Norris Cotton Cancer Center ku Dartmouth Hitchcock Medical Center

Northwestern University - Robert H. Lurie Comprehensive Cancer Center

Malo Ophunzirira Khansa ku Ohio State University

Institute ya Khansa ya Roswell Park

Sidney Kimmel Cancer Center ku Jefferson Health

University of Alabama ku Birmingham

Yunivesite ya California Davis Comprehensive Cancer Center

Yunivesite ya Chicago Comprehensive Cancer Center

University of Colorado Cancer Center

Malo Ophunzirira Khansa ku University of Michigan

University of North Carolina Lineberger Comprehensive Cancer Center

University of Oklahoma - Stephenson Cancer Center

Institute of Cancer ku University of Pittsburgh

Yunivesite ya Rochester Wilmot Cancer Institute

University of Southern California - Norris Comprehensive Cancer Center

University of Texas MD Anderson Cancer Center

Yunivesite ya Texas Southwestern Medical Center - Harold C. Simmons Cancer Center

University of Utah - Huntsman Cancer Institute

University of Wisconsin Carbone Cancer Center

Vanderbilt University Medical Center - Vanderbilt Ingram Cancer Center

University of Washington ku St. Louis - Siteman Cancer Center

Wayne State University Barbara Ann Karmanos Cancer Institute

Yale University - Yale Cancer Center

Kuchuluka kwa olembetsa odwala kumafunikira mulingo wokhazikika pantchito yoyang'anira deta kwa zaka zingapo, ndipo zopereka za LAPS zimathandizira ofufuza omwe akuyenera kuthana ndi izi. Ndalama zoperekedwa mu ndalama za LAPS kuti zithandizire kuchuluka kwa ntchitoyo kumakweza mulingo wobwezera wodwalayo m'malo omwe asankhidwa.

Mphoto za LAPS zimaperekanso ndalama kwa utsogoleri wa asayansi ndi oyang'anira pamalowo, popeza ofufuza oyang'anira tsambalo akuyenera kuyika mayeso azachipatala omwe amatenga nawo mbali, komanso kuphunzitsa ndi kuphunzitsa ogwira ntchito m'malo omwe amafufuza zamankhwala ndikupanga chitukuko njira zothandizira kulembetsa odwala.

Mzipatala ndi Zipatala

Ofufuza ena ambiri kuzipatala zam'madera ndi malo azachipatala atha kutenga nawo mbali m'mayesero a NCTN, ngakhale atakhala m'malo omwe sanalandire mphotho ya LAPS. Masambawa, komanso masamba angapo apadziko lonse lapansi, amalandila ndalama zobwezera kafukufuku kuchokera ku gulu limodzi lomwe amalumikizana nalo kapena amalandila mphotho kuchokera ku NCI Community Oncology Research Program (NCORP).

Umembala wamasamba m'magulu amtundu wa NCTN umakhazikitsidwa pamiyeso yomwe ikukhudzana ndi gulu lililonse. Masamba omwe amayesa mayesero azachipatala atha kukhala am'magulu opitilira umodzi, ndipo kukhala mgulu limodzi kumalola kuti tsamba litenge nawo mbali pamayeso omwe amatsogozedwa ndi gulu lililonse la NCTN lomwe ofufuza awo ali oyenerera. Zotsatira zake, ofufuza ochokera ku LAPS, NCORP, malo ena ophunzirira, zochitika mdera lawo, komanso mamembala apadziko lonse lapansi omwe amagwirizana ndi magulu a Network atha kulembetsa odwala m'mayesero a NCTN.

Kujambula ndi Kutulutsa Mafupa Oncology Core Gulu (IROC)

Pofuna kuwunika ndikuwunika bwino pamayeso omwe akuphatikiza njira zatsopano zoganizira ndi / kapena mankhwala a radiation, NCTN idakhazikitsa Imaging and Radiation Oncology Core (IROC) GroupExit Disclaimer yomwe imathandizira magulu onse a NCTN omwe amagwiritsa ntchito njirazi pamayeso awo.

Mphotho Yophatikiza Yotanthauzira Sayansi (ITSA)

Gawo lomaliza la NCTN ndi Integrated Translational Science Awards (ITSAs). Maphunziro asanu omwe adalandira ma ITSA akuphatikiza magulu asayansi omasulira omwe amagwiritsa ntchito matekinoloje anzeru, ma proteomic, ndi kujambula kuti athandizire kuzindikira ndikuwunika omwe angayankhe poyankha mankhwala omwe magulu azigawo angapangire mayesero amtsogolo mtsogolo.

Mphothozi zimagwiritsidwa ntchito popititsa patsogolo ntchito zomwe zikuchitika kale m'ma laboratories ofufuzirawa, omwe nthawi zambiri amathandizidwa ndi zopereka zina za NCI, ndikuyembekeza kuti ofufuzawa athandiza magulu amtunduwu kuti abweretse zatsopano zama labotale m'mayesero azachipatala. Ma lab awa onse amagwiritsa ntchito matekinoloje odulira omwe amathandizira kuzindikira kwa zotupa ndikuthandizira kuzindikira kusintha kwa biology ya chotupa poyankha chithandizo chomwe chingathandize kufotokoza momwe kukana mankhwala kungayambire.

Othandizira a ITSA ndi awa:

Chipatala cha Ana ku PhiladelphiaExit Chodzikanira

Emory University - Winship Cancer InstituteExit Disclaimer

Chikumbutso cha Sloan Kettering Cancer CenterTuluka Chodzikanira

Ohio State University Comprehensive Cancer CenterChotsani Chodzikanira

University of North Carolina Lineberger Comprehensive Cancer CenterChotsani Chodzikanira

Mabanki Amisempha a NCTN

Gulu lirilonse la NCTN limasonkhanitsanso ndikusunga minofu kuchokera kwa odwala m'mayesero a NCTN mgulu logwirizana lamabanki amtundu. Ndondomeko zokhazikika zapangidwa kuti zitsimikizire kuti minofu yomwe yasonkhanitsidwa ndiyabwino kwambiri. Zolemba pakompyuta zazomwe zasungidwa zili ndi zambiri zamankhwala, monga mankhwala omwe odwala amachotsedwa, mayankho ake, komanso zotsatira zake. Ophunzira nawo pamayeso a NCTN amathanso kuvomereza kugwiritsa ntchito mitundu yawo yazinyama pamaphunziro omwe sanayesedwe pa NCTN pomwe adalembetsa. Pulogalamu ya banki ya NCTN imaphatikizira njira yapaintaneti yomwe wofufuza aliyense angagwiritse ntchito. Ofufuza, kuphatikiza iwo omwe sagwirizana ndi NCTN,

Makomiti Oyang'anira Sayansi

Magulu a NCTN amapangira malingaliro am'mayesero atsopano azachipatala kumakomiti oyang'anira matenda a NCI / Imaging. Makomitiwa amakonzedwa ndi NCI kuti iwunikire ndikuyika mayesero atsopano azachipatala ndikuwalangiza kwa NCI omwe atenga nawo gawo pazasayansi komanso zamankhwala. Komiti iliyonse imatsogoleredwa ndi apampando omwe siaboma omwe saloledwa kukhala ndi utsogoleri m'magulu a NCTN, ngakhale atakhala mamembala. Otsala a mamembala a komitiyi ali ndi mamembala a NCTN omwe asankhidwa ndi gulu lirilonse, akatswiri ena azachipatala omwe satenga nawo mbali m'magulu, oimira SPORE omwe amalipiridwa ndi NCI ndi Consortia, akatswiri azachipatala, othandizira odwala, komanso akatswiri a matenda a NCI.

Bajeti ya NCTN

Bajeti yonse ya NCTN ndi $ 171 miliyoni, yogawidwa kuzinthu zosiyanasiyana za netiweki. Njirayi imapereka mwayi wopezeka pachaka kwa pafupifupi 17,000-20,000 omwe amatenga nawo mbali pachithandizo cha khansa komanso kuyesa kulingalira.

Kuchita bwino mogwirizana

Magulu a NCTN amatha kuchepetsa ndalama zoyeserera pogawana zinthu. Njira yothandizirayi imalola mamembala am'magulu amodzi a NCTN kuti athandizire mayesero motsogozedwa ndi magulu ena ndipo imapatsa mamembala a NCTN kuthekera kochita mayesero onse mu khansa yofala kwambiri.

Chifukwa NCTN ili ndimagulu akulu anayi aku US, omwe ali ndi Opaleshoni ndi Ma Statistical Center ochepa omwe amafunikira thandizo lazachuma, pakhala ndalama zosungidwa. Magulu onsewa amagwiritsa ntchito njira yofananira yosungira deta (Medidata Rave) ndi njira yolumikizira IT yamabanki amisempha, zomwe zimamasulira ndalama.

Thandizo lowonjezera

Mayesero azachipatala ndi ntchito zovuta zomwe zimafuna mabungwe ambiri othandizira ndi ndalama zothandizira. Ma netiwekiwa amaphatikizaponso zina zambiri zomwe sizinaphatikizidwe mu mphotho za NCTN koma zomwe ndizofunikira pokwaniritsa ntchito ya NCTN.

Thandizo lowonjezera limaphatikizapo:

• Central Institutional Review Boards, gawo lofunikira pamakina oyeserera azachipatala a NCI omwe amawonjezera kuthamanga, kuchita bwino, ndi kufanana pamawunikidwe amachitidwe.

• Cancer Trials Support Unit (CTSU), mgwirizano wothandizidwa ndi NCI womwe umapatsa ofufuza zamankhwala ndi ogwira nawo ntchito mwayi wopezeka pa intaneti mayesero a NCTN ndipo amalola ofufuza kuti alembetse odwala atsopano.

• Banki yodzipereka ya gulu lililonse la Network imalipira ndalama kudzera munjira yapadera ya mphotho ya NCI.

• Biomarker, Imaging, and Quality of Life Study Funding Program (BIQSFP), njira yopezera ndalama zoyeserera za NCTN zomwe zimathandizira maphunziro a sayansi pamayeso am'magulu. Magulu a NCTN amapikisana ndi ndalama zomwe zimasungidwa pachaka kuti zitheke. Kupezeka kwa ndalama zodzipereka kumathandizira kwambiri kulumikizana, popeza mayesero azachipatala ayenera kukwaniritsa nthawi yayitali.

• Kuphatikiza apo, pafupifupi kotala limodzi la odwala omwe amalandira mayesero a NCTN amalipiridwa ndi pulogalamu ya NCORP. Zipatala zam'madera ndi malo azachipatala omwe akutenga nawo gawo mu pulogalamu ya NCORP amalipidwa chifukwa chololeza odwala ku mayesero a NCTN ndi mphotho zawo za NCORP, osati kudzera mu mphotho ya NCTN 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.

Mgwirizano pakati pamaguluwo umawoneka kuti ndiwofunika kwambiri kuti zinthu zikuyendere bwino mgulu lonse la mabungwe ndipo tsopano wapinduladi makamaka panthawi yobwereza. Kuchita bwino kumatsindikitsidwanso, ndipo nthawi zoyenerera tsopano zikupezeka pakukula kwa protocol. Ngakhale kusintha kumeneku kumawoneka kofunikira pathanzi laanthu, kumabweranso nthawi yabwino, chifukwa kusintha kosangalatsa kwa sayansi ya oncologic ikupereka njira zatsopano zopitilira patsogolo mwachangu, makamaka pakukhazikitsa njira zatsopano zamankhwala.