UNjingalwazi Con Tam, Peter MacCallum Cancer Centre
Yintoni ulingo lwezonyango?
Ulingo lwezonyango luyinxalenye ebalulekileyo yophando lwezempilo. Ulingo lwezonyango yindlela elawulwayo yokuphendula imibuzo ebalulekileyo malunga nonyango olutsha, ubugcisa, iimvavanyo okanye indlela entsha yokunika unyango. Ulingo lwezonyango luya kubuza imibuzo efana nale;
- Ukhuseleko kunye nokusebenza kwamayeza amatsha
- Ukongezwa kwamayeza amatsha kunyango oluqhelekileyo
- Ukujonga iindlela ezintsha zokunika unyango olusemgangathweni
- Thelekisa unyango olutsha noludala ukuze ubone ukuba loluphi oluvelisa iziphumo ezingcono ezineziphumo ebezingalindelekanga ezimbalwa
Olona nyango lubalaseleyo luvunyiweyo ukuba lusetyenziswe sisiphumo seminyaka emininzi yelabhoratri kunye nophando lwezonyango.
Eyona nto ibalulekileyo xa kuqhutywa ulingo lwezonyango lukhuseleko kunye nempilo yezigulane ezithatha inxaxheba. Zonke iimvavanyo zeklinikhi e-Australia ziye zahlaziywa ngokungqongqo kwaye zavunywa ngamakomiti ahlukeneyo ukuqinisekisa ukuba ulingo lwesayensi kunye nokuziphatha kakuhle kwaye luhlangabezana nazo zonke iimfuno zokulawula zase-Australia. Olu phononongo kufuneka lugqitywe phambi kokuba ulingo lwezonyango lubhalise izigulane.
Ulingo lwezonyango lulawulwa zizikhokelo zokuziphatha zelizwe kunye nemigaqo yokuziphatha. Ngolwazi oluthe vetshe ngeemfuno, bona Ingxelo yeSizwe malunga neNdlela yokuziphatha kuPhando loLuntu kwaye i IKhowudi yase-Australia yoKuziphatha ngoXanduva koPhando.
Izilingo zeklinikhi zezinto ezingavunywanga kunye nezixhobo kufuneka zihambelane neemfuno zoLawulo lweeMpahla zoNyango (TGA) kunye nezikhokelo zamazwe ngamazwe, njengoko zamkelwe yi-TGA. Therapeutic Goods Administration (TGA) lisebe likaRhulumente wase-Australia elilawula onke amayeza athengiswayo e-Australia. Naliphi na iyeza lokulinga elisetyenziswe kulingo lwezonyango kufuneka libhaliswe kwi-TGA. Ukuze ufumane inkcazelo engakumbi, tyelela tga.gov.au.
Ulingo lwezonyango luxhomekeke kuphononongo kunye nophicotho ziinkampani ezixuba amayeza, amaqumrhu olawulo elizwe kunye namazwe ngamazwe afana ne-TGA kunye ne-FDA.
Indlela engqongqo yokuba ulingo lwezonyango luvunyiwe kwaye luqhutywa luqinisekisa ukuba ukhuseleko kunye namalungelo abathathi-nxaxheba akhuselwe kwaye idatha eqokelelweyo ikumgangatho ophezulu.
UNjingalwazi Judith Trotman, kwisibhedlele saseConcord
Zenziwa njani amalingo onyango?
Ulingo lwezonyango luyilwe ngendlela yenzululwazi ukuze lulunge kwaye lukhuseleke kwizigulane ezithatha inxaxheba.
Ukuvavanya amayeza amatsha kunye neendlela zokufumana unyango kuthatha ixesha elide. Phambi kokuba unyango luvavanywe ebantwini, oosonzululwazi noogqirha bachithe iminyaka emininzi besenza uphando lwaselabhoratri. Isicwangciso senziwe ukuvavanya unyango olutsha ngezigaba. Iziphumo zolingo ngalunye zihlalutywa phambi kokuba ziqhubele phambili ziye kwisigaba esilandelayo.
Kukho izigaba ezi-4 zolingo lwezonyango:
| Injongo | Iqhutywa njani | |
| Isigaba I | Vavanya iprofayili yokhuseleko kunye nemiphumo emibi Misela idosi ekhuselekileyo eya kuhlolwa ngakumbi kulingo lwesigaba samva | Amanani amancinane kakhulu abathathi-nxaxheba (20-50) Kulingo lwamayeza amatsha, abathathi-nxaxheba badla ngokunikwa idosi encinci kakhulu kwaye emva kokuba idosi ibonwe njengekhuselekile iya kongezwa kwiqela elilandelayo labathathi-nxaxheba. Abathathi-nxaxheba rhoqo kuya kufuneka ukuba babe novavanyo olongezelelweyo, umzekelo, uvavanyo lwegazi, uvavanyo lwentliziyo. |
| ISigaba 2 | Ukujonga ngakumbi kwiprofayili yokhuseleko Ukujongwa ngokusondeleyo kwindlela idosi yeyeza elisebenza ngayo ngokuchasene nesifo | Amanani amakhulu kunolingo lwesigaba soku-1 (100-500) |
| ISigaba 3 | Esi sigaba sithelekisa iyeza elitsha okanye unyango kunyango lwangoku | Amanani amakhulu abathathi-nxaxheba ababhalisileyo (ngaphezu kwama-300+) |
| ISigaba 4 | Nje ukuba iyeza livunyiwe ukuba lisetyenziswe olu lingo luyilelwe ukujonga ukusebenza kweyeza elivunyiweyo kubemi ngokubanzi | Amanani amakhulu kakhulu abathathi-nxaxheba |
Kuthetha ukuthini i-randomisation?
Xa amalingo ethelekisa unyango oluchaseneyo kaninzi luhlala lungenamkhethe. Oku kuthetha ukuba xa sele uvumile ukungena kulingo, ikhompyutha iya kukwabela ngokungakhethiyo kwenye yeendlela zonyango. Unyango luhlala lubizwa ngokuba "ziingalo zonyango"
Akunawe okanye ugqirha wakho onokukhetha ukuba yeyiphi ingalo yonyango oyinikiweyo. Le nkqubo isetyenziselwa ukuqinisekisa ukuba ulingo lunobulungisa kwaye iziphumo ezivela kwiqela ngalinye zinokuthelekiswa ngokwenzululwazi.
Kuthetha ukuthini ukumfamekisa?
Ubumfama bubhekisa kwisenzo sokufihla uhlobo lonyango olufunyanwa ngumthathi-nxaxheba. Ukumfameka kusetyenziswa kwamanye amalingo ukuze abathathi-nxaxheba bangazi ukuba loluphi unyango olufunyenweyo. Oku kwaziwa njengolingo oluyimfama. Kulingo lwezonyango olumfamekileyo, abathathi-nxaxheba abazi ukuba yeyiphi ingalo yophononongo abakuyo. Injongo yokumfamekisa kukunciphisa icala ekuxelweni kweenzuzo kunye neziphumo ebezingalindelekanga.
Yintoni i-placebo?
I-placebo lunyango olungasebenziyo okanye oluhlekisayo. Yenziwa ukuba ibukeke, incasa okanye ivakale ngathi unyango luyavavanywa. Umahluko kukuba ayiqulathanga naziphi na izithako ezisebenzayo. I-placebo isetyenziselwa ukuqinisekisa ukuba iziphumo zingenxa yonyango lwangempela. Ukuba i-placebo isetyenzisiwe, iya kuba yongezwa kunyango oluqhelekileyo. Awunalo unyango lwe-placebo ngokwalo. Umzekelo unokufumana unyango olusemgangathweni kunye nonyango lovavanyo. Unokufumana unyango olusemgangathweni kunye ne-placebo.
Uyakuhlala uxelelwa ukuba ulingo okulo lusebenzisa ii-placebos. Awuyi kuxelelwa ukuba ufumana unyango lovavanyo okanye i-placebo.
UGqr Michael Dickinson, iZiko loMhlaza likaPeter MacCallum
Kwenzeka ntoni kulingo lwezonyango?
Ulingo lwezonyango luqhutywa ngokwesicwangciso esisetwe kwangaphambili okanye iprotocol. Umgaqo wokuziphatha umisela ukuba zeziphi izigulane ezinokubhaliswa kulingo, loluphi uvavanyo olufunekayo, unyango olunikwayo kunye nolandelelo olufunekayo. Unokufunda ngakumbi malunga nokunokwenzeka xa ubhalisa kulingo lwezonyango.
Ithetha ntoni imvume enolwazi?
Phambi kokuba nabani na abe nokubhaliswa kulingo lwezonyango, kufuneka asayine ifomu yemvume. Le nkqubo ibaluleke kakhulu. Ukuthatha inxaxheba kukuzithandela ngokupheleleyo. Akukho mntu kufuneka anyanzelwe okanye anyanzelwe ukuba athathe inxaxheba kulingo lwezonyango. Oogqirha kunye neqela lovavanyo lweklinikhi liya kukucacisela ngolingo lwezonyango ngokweenkcukacha. Baya kuqinisekisa ukuba unalo iphepha lolwazi olubhaliweyo. Uya kunikwa ixesha elininzi lokufunda ulwazi kwaye ucinge malunga nokuba ungathanda na ukuthatha inxaxheba. Kubalulekile ukuba ukuqonde kakuhle okubandakanyekayo kuquka iinzuzo kunye neengozi zokuthatha inxaxheba. Olunye ulingo lweklinikhi lunokufuna ukuba ube nexesha elongezelelweyo kunye novavanyo. Konke oku kuya kucaciswa kwaye kuya kuba kwiphepha lolwazi. Ungathatha ixesha lokuxoxa oku nosapho lwakho, abahlobo okanye nogqirha wosapho lwakho. Awunyanzelekanga ukuba uthathe inxaxheba kulingo lwezonyango. Sisigqibo sakho ngokupheleleyo kwaye oogqirha bakho bayaqonda ukuba awufuni ukuthatha inxaxheba. Ukuba uthatha isigqibo sokungathathi nxaxheba uya kufumana unyango lwangoku olukhoyo kuwe.
Nje ukuba uthathe isigqibo sokuthatha inxaxheba, kuya kufuneka usayine ifomu yemvume. Oku kwenziwa kunye nogqirha wakho
Kuthetha ukuthini ukufaneleka kolingo lwezonyango?
Wakuba uvumile ukuthatha inxaxheba kwaye usayine ifomu yemvume, uya kuqalisa inkqubo yokuqinisekisa ukuba ityala likulungele. Oku kwaziwa njengokugqibezela iinqobo zokugweba zokufaneleka. Ezi yimfuneko emazifikelelwe, ukuqinisekisa ukuba abantu abathatha inxaxheba bayafana kangangoko. Ukuba ulingo alufanelekanga ngenxa yokuba awufikeleli ukufaneleka, ugqirha wakho uya kuxoxa ngezinye iindlela kunye nawe.
impatho
Nje ukuba zonke iikhrayitheriya zokufaneleka zivavanyiwe kwaye ukuba ngaba ulingo lukulungele, uya kwabelwa iqela lonyango. Ngexesha lonyango uya kutyelela isibhedlele rhoqo ukuze ufumane unyango kunye neemvavanyo. Kusenokufuneka wenze utyelelo olongezelelweyo kwaye ube novavanyo olongezelelweyo. Kusenokufuneka uphendule imibuzo ngendlela oziva ngayo. Imiyalelo iya kuchazwa ngugqirha wakho kunye nonesi. Ulwazi lukwakwiphepha lolwazi olufumene phambi kokuba uvume ukuthethwa kwetyala. Kubalulekile ukuba ulandele yonke imiyalelo oyinikiweyo kwaye ukuba unayo nayiphi na imibuzo qhagamshelana nogqirha wakho okanye umongikazi wakho.
Ukulandela ukhathalelo
Xa ulugqibile unyango lwakho, uye kwisigaba esaziwa ngokuba kulandelelwaniso. Uza kubonwa ngugqirha wakho kunye nonesi kwaye kungafuneka ukuba wenze uvavanyo olongezelelweyo. Umzekelo, iimvavanyo zegazi, iimvavanyo zentliziyo okanye imibuzo.
Ukurhoxa kulingo lwezonyango
Ukuba uthatha isigqibo sokuba awusafuni ukubandakanyeka kulingo lwezonyango ungaphuma nangaliphi na ixesha, ngaphandle kwengcaciso. Awuyi kohlwaywa ngenxa yoku. Ukuba uyayirhoxisa imvume yakho, uya kufumana unyango oluqhelekileyo olulolona khetho lungcono kuwe okwangoku.
Indlela yokufumana ulingo lwezonyango?
Ugqirha wakho uya kwazi malunga nolingo lwezonyango olulungele wena. Ukuba ugqirha wakho akathethi nawe malunga nezilingo zeklinikhi kwaye unomdla wokuthatha inxaxheba, unokucela ugqirha wakho ukuba kukho nantoni na ekhoyo. Ungabuza nokuba akhona na amalingo kwezinye izibhedlele ozimisele ukuya kuwo. Ugqirha wakho akayi kukhubeka ukuba uyabuza.
Kukho iindawo ezininzi onokuzifumana malunga nolingo lwezonyango;
Iqela lezonyango
Inyathelo lokuqala kukuthetha nogqirha wakho malunga nokuba zeziphi na iindlela onokukhetha kuzo. Kufuneka ubuze ukuba kukho ulingo lwezonyango olukhoyo olukulungeleyo. Ugqirha wakho wazi wena kunye nembali yakho yonyango ngcono. Ngokuqhelekileyo baya kukwazi ukuba kukho nantoni na efanelekileyo kwisibhedlele sakho, indawo kunye ne-interstate. Ukuba abayazi malunga nolingo lwezonyango olukhoyo, banokubuza abanye oogqirha abangqonge i-Australia ukuba bayalwazi ngolingo.
Uluvo lwesibini
Enye inketho kukucela uluvo lwesibini kunye nomnye ugqirha. Izigulana ezininzi zicela uluvo lwesibini. Oogqirha abaninzi nabo bakhululekile ngale nto, ngoko ungakhathazeki ngokubacaphukisa. Oogqirha abaninzi bayaqonda ukuba ubomi bakho bubalulekile kwaye kufuneka uzive ukhululekile ukuba ubuze yonke imibuzo eyiyo kwaye uyazazi iinketho zakho.
I-ClinTrial Refer
Le yiwebhusayithi yase-Australia eyenzelwe ukwandisa ukuthatha inxaxheba kuphando lwezilingo zeklinikhi. Ifumaneka kuzo zonke izigulane, zonke iimvavanyo, bonke oogqirha. Injongo kuku:
- Yomeleza uthungelwano lophando
- Qhagamshelana nabathunyelwe
- Ukufakela inxaxheba kwizilingo njengokhetho lonyango
- Ukwenza umehluko kumsebenzi wophando lweklinikhi
- Kukwakho nenguqulelo ye-app
ClinicalTrials.gov
I-ClinicalTrials.gov yidathabheyisi yezifundo zeklinikhi ezizimeleyo nezixhaswa ngurhulumente eziqhutywa kwihlabathi jikelele. Izigulane zinokuchwetheza kwi-lymphoma subtype yazo, ulingo (ukuba luyaziwa) kunye nelizwe labo kwaye luya kubonisa ukuba loluphi ulingo olukhoyo ngoku.
I-Australasian Leukemia & Lymphoma Group (ALLG)
ALLG & nolingo lwezonyango
UKate Halford, ALLG
I-Australasian Leukemia & Lymphoma Group (ALLG) yi-Australia kunye ne-New Zealand kuphela kweqela lophando lophando lomhlaza wegazi lovavanyo lwezonyango. Iqhutywa yinjongo yabo 'Unyango olungcono…Ubomi obungcono', i-ALLG izibophelele ekuphuculeni unyango, ubomi kunye namazinga okuphila kwezigulane ezinomhlaza wegazi ngokuziphatha kolingo lwezonyango. Ukusebenza ngokubambisana neengcali zomhlaza wegazi ngaphakathi nangaphandle, impembelelo yabo inzulu. Amalungu ngoogqirha begazi, kunye nabaphandi abavela kulo lonke elaseOstreliya abasebenza nabalingane kwihlabathi liphela.
Uphando lomhlaza wegazi eNtshona Australia
A/Prof Chan Cheah, Sir Charles Gairdner Hospital, Hollywood Private Hospital & Blood Cancer WA
Iziko loPhando loMhlaza weGazi laseNtshona Australia, ligxile kuphando lweLeukemia, iLymphoma kunye neMyeloma. Injongo yabo kukunika izigulane ze-WA ezinomhlaza wegazi ukufikelela kunyango olutsha nolunokusindisa ubomi, ngokukhawuleza.
Ulingo lwezonyango yeyona ndlela ilungileyo yokufezekisa oku kwaye lwenziwa kwiindawo zethu ezintathu zasePerth, iSibhedlele iSir Charles Gardiner, iLinear Clinical Research kunye neHollywood Private Hospital.
Australia Uvavanyo lomhlaza
Le webhusayithi iqulathe kwaye ibonelela ngolwazi olubonisa ulingo lwamva nje lwezonyango kukhathalelo lomhlaza, kuqukwa nezilingo ngoku ezifuna abathathi-nxaxheba abatsha.
IZiko loMhlaza kaPeter MacCallum
Peter MacCallum Cancer Centre liziko lomhlaza elikumgangatho wehlabathi. Ziziko lophando lomhlaza likhulu eOstreliya elinamalungu angaphezu kwama-750 elabhoratri kunye nabasebenzi bophando lwezonyango. Ungafumana ngakumbi malunga nolingo lwabo lwezonyango kunye nokufaneleka kwakho kwiwebhusayithi yabo.
IRejistri yovavanyo lwezonyango yase-Australia yaseNew Zealand
I-Australian New Zealand Clinical Trial Registry (ANZCTR) yirejistri ye-intanethi yolingo lwezonyango olwenziwe e-Australia, eNew Zealand nakwezinye iindawo. Ndwendwela iwebhusayithi ukubona ukuba loluphi ulingo olufunayo ngoku.
Umanyano lweLymphoma
I-Lymphoma Coalition, uthungelwano lwehlabathi lonke lwamaqela ezigulane ze-lymphoma, yasekwa ngo-2002 kwaye yahlanganiswa njengentlangano engenzi nzuzo ngo-2010. Injongo yayo ecacileyo kukudala indawo yokudlala yolwazi kwihlabathi jikelele kunye nokuququzelela uluntu lwemibutho yezigulane ze-lymphoma. ukuxhasana iinzame zokunceda abaguli abane-lymphoma bafumane ukhathalelo nenkxaso efunekayo.
Isidingo se-central hub yolwazi oluchanekileyo kunye noluthembekileyo lwangoku lwaqatshelwa kunye nesidingo semibutho yezigulane ze-lymphoma ukwabelana ngezibonelelo, iindlela ezifanelekileyo, kunye nemigaqo-nkqubo kunye neenkqubo. Ngale nto engqondweni, imibutho emine ye-lymphoma yaqala i-LC. Namhlanje, kukho imibutho engama-83 ephuma kumazwe angama-52.
Ukuba ufumana ulingo onomdla wokulujoyina, buza ugqirha wakho ukuba uyahlangabezana na nemigaqo yokufaneleka kwaye, ukuba kunjalo, nokuba banokunxibelelanisa ukubandakanyeka kwakho okanye bakudibanise neqela lophando.
Ziziphi iingenelo zokuthatha inxaxheba kulingo lwezonyango?
Olona ncedo luphambili lokuthatha inxaxheba kulingo lwezonyango kukuba abantu banokufumana unyango olutsha olungekafumaneki kuqheliselo lwezonyango, okanye unyango olukhoyo olungafumanekiyo kwiimeko zabo. Umzekelo, ukuba umntu ufumene unyango oluqhelekileyo kuhlobo oluthile lwe-lymphoma kwaye akayifumananga impendulo efunekayo, ulingo lwezonyango lunokuba lukhetho oluhle. Unyango lophando alufumaneki kubantu abangaphandle kolingo lwezonyango. Ukuze unyango lunikwe abantu baseOstreliya, kufuneka ukuba luphononongwe ngokungqongqo lwaza lwavavanywa, kwaye kufuneka luvunywe yi-Therapeutic Goods Administration (TGA). I-TGA liqumrhu likarhulumente elivavanya kwaye libeke esweni zonke iimpahla zonyango ukuqinisekisa ukuba zikumgangatho owamkelekileyo phambi kokuba zifumaneke kuluntu lwase-Australia.
Yeyiphi imingcipheko yokuthatha inxaxheba kulingo lwezonyango?
Kufuneka wazi iingozi phambi kokuthatha inxaxheba kulingo lwezonyango. Ziquka:
- Unyango lunokuba yityhefu kangangokuba ube neziphumo ebezingalindelekanga ezimandundu okanye ezingaziwayo
- Unyango lusenokubonakala lungasebenzi kangako kunonyango oluqhelekileyo kwaye lunike uncedo oluncinane okanye lungabikho kwaphela
- Unokuba kwiqela lolawulo lolingo lweklinikhi kwaye unokufumana unyango oluqhelekileyo lwe-lymphoma kwaye hayi unyango lovavanyo.
Imibuzo yokubuza ugqirha wakho
- Yintoni injongo yolu lingo lwezonyango?
- Isifundo siya kuhlala ixesha elingakanani?
- Ngaba ndiya kuba ngcono xa ndikwisifundo?
- Isifundo sinokubuchaphazela njani ubomi bam bemihla ngemihla?
- Ngaba ziya kubakho iindleko zokuba ndibe selufundweni?
- Ngaba wonke umntu onesifo sam uyalufanelekela olu lingo?
- Ukuba ndithatha inxaxheba kulingo, andizukulufumana olona nyango lukhoyo?
Ukuqonda izilingo zeklinikhi - iividiyo zeLymphoma Australia
UNjingalwazi Judith Trotman, kwisibhedlele saseConcord
UGqr Michael Dickinson, iZiko loMhlaza likaPeter MacCallum
UNjingalwazi Con Tam, Peter MacCallum Cancer Centre
UGqr Eliza Hawkes, i-Austin Health & ONJ iziko lophando lomhlaza
UGqr Eliza Hawkes, i-Austin Health & ONJ iziko lophando lomhlaza
UKate Halford, ALLG
A/Prof Chan Cheah, Sir Charles Gairdner Hospital, Hollywood Private Hospital & Blood Cancer WA
Ulingo lwezonyango luvulekele ukufunwa
Uphononongo lweKlinikhi: iTislelizumab yabathathi-nxaxheba abaBuyiselwa kwakhona okanye abaRefractory Classical Hodgkin Lymphoma (TIRHOL) [njengangoJulayi 2021]
Imithombo yolwazi
INkcazelo yeSizwe malunga neNdlela yokuziphatha kuPhando loLuntu (2007) (iNgxelo yeSizwe (2007) iqulethe uluhlu lwezikhokelo ezenziwe ngokuhambelana noMthetho weBhunga loPhando lwezeMpilo leSizwe we-1992.
IKhowudi yase-Australia yeNdlela yokuziPhatha ngoXanduva, i-2018
Ngaba uJ Surg. I-2010 Oct; I-53 (5): 345-348.
Ubumfama: ngubani, yintoni, nini, kutheni, njani?
UPaul J. Karanicolas, MD, PhD,*† Ngokucacileyo Farrokhyar, MPhil, PhD, †‡ kunye Mohit Bhandari, MD, MSc
