Ukuqonda Izivivinyo Zomtholampilo

USolwazi Con Tam, Peter MacCallum Cancer Center

Ukuqonda ishidi leqiniso lesivivinyo somtholampilo

Yiziphi izivivinyo zomtholampilo?

Ukuhlolwa komtholampilo kuyingxenye ebalulekile yocwaningo lwezempilo. Ukuhlolwa Komtholampilo kuyindlela elawulwayo yokuphendula imibuzo ebalulekile mayelana nokwelashwa okusha, ubuchwepheshe, izivivinyo noma indlela entsha yokunikeza ukwelashwa. Ukuhlolwa komtholampilo kuzobuza imibuzo efana nale;

Ukuphepha nokusebenza kwemithi emisha
Ukwengezwa kwemithi emisha ekwelashweni okujwayelekile
Ukubheka izindlela ezintsha zokunikeza ukwelashwa okujwayelekile
Qhathanisa ukwelashwa okusha nezindala ukuze ubone ukuthi yikuphi okukhiqiza imiphumela engcono enemiphumela engemihle embalwa

Ukwelashwa okuhle kakhulu okugunyazwe ukusetshenziswa njengamanje kuwumphumela weminyaka eminingi yocwaningo lwaselabhorethri nolwemitholampilo.

Isici esibaluleke kakhulu lapho kwenziwa uhlolo lomtholampilo ukuphepha nokuphila kahle kweziguli ezibamba iqhaza. Zonke izivivinyo zemitholampilo e-Australia zibuyekezwe ngokuqinile futhi zagunyazwa amakomiti ahlukahlukene ukuze kuqinisekiswe ukuthi ukuhlolwa kunengqondo ngokwesayensi nangokokuziphatha futhi kuhlangabezana nazo zonke izidingo zokulawula zase-Australia. Lezi zibuyekezo kufanele ziqedwe ngaphambi kokuthi uhlolo lomtholampilo lubhalise iziguli.

Izivivinyo zemitholampilo zibuswa yiziqondiso zokuziphatha kazwelonke kanye namakhodi okuziphatha. Ukuze uthole ulwazi olwengeziwe mayelana nezidingo, bheka ku Isitatimende Sikazwelonke Sokuziphatha Ocwaningweni Lwabantu futhi Ikhodi yase-Australia Yokuziphatha Okubophezelekile Kocwaningo.

Ukuhlolwa komtholampilo kwezinto ezingagunyaziwe namadivayisi kufanele kuthobelane nezimfuneko ze-Therapeutic Goods Administration (TGA) kanye nemihlahlandlela yamazwe ngamazwe, njengoba yamukelwe i-TGA. I-Therapeutic Goods Administration (TGA) iwumnyango kaHulumeni wase-Australia olawula yonke imithi ethengiswa e-Australia. Noma yimuphi umuthi ohlolwayo osetshenziswa ocwaningweni lomtholampilo kumele ubhaliswe ne-TGA. Ukuze uthole ulwazi olwengeziwe, vakashela tga.gov.au.

Izivivinyo zemitholampilo zingaphansi kokubuyekezwa kanye nokuhlolwa kwezinkampani zemithi, izinhlangano ezilawulayo zikazwelonke nezamazwe ngamazwe njenge-TGA ne-FDA.

Indlela eqinile izivivinyo zomtholampilo ezigunyazwa ngayo futhi eziqhutshwa ngayo iqinisekisa ukuthi ukuphepha namalungelo ababambiqhaza avikelekile nokuthi idatha eqoqiwe ingeyekhwalithi ephezulu.

USolwazi Judith Trotman, esibhedlela iConcord

Ziklanywa kanjani izivivinyo zemitholampilo?

Izivivinyo zemitholampilo ziklanywe ngendlela yesayensi ukuze zingenzeleli futhi ziphephe ezigulini ezibamba iqhaza.

Ukuhlola imithi emisha nezindlela zokwelashwa kuthatha isikhathi eside. Ngaphambi kokuthi ukwelashwa kuhlolwe kubantu, ososayensi nodokotela bachithe iminyaka eminingi benza ucwaningo lwaselabhorethri. Kwenziwa uhlelo lokuhlola ukwelashwa okusha ngezigaba. Imiphumela yocwaningo ngalunye luyahlaziywa ngaphambi kokuthi ludlulele esigabeni esilandelayo.

Kunezigaba ezi-4 zokuhlolwa komtholampilo:

	Injongo	Iqhutshwa kanjani
Isigaba I	Linganisa iphrofayili yokuphepha nemiphumela emibi Misa umthamo ophephile ozobuye uhlolwe ezivivinyweni zesigaba sakamuva	Inani elincane kakhulu labahlanganyeli (20-50) Ezivivinyweni zemithi emisha, ababambiqhaza bavamise ukunikezwa umthamo omncane kakhulu bese kuthi uma lo mthamo usubonakale uphephile uzokwenyuselwa iqembu elilandelayo labahlanganyeli. Ngokuvamile ababambiqhaza bazodinga ukuhlolwa okwengeziwe, isibonelo, ukuhlolwa kwegazi, ukuhlolwa kwenhliziyo.
Isigaba 2	Uma ubheka kabanzi iphrofayili yokuphepha Ukubhekisisa kabanzi ukuthi umthamo womuthi usebenza kahle kangakanani ngokumelene nesifo	Izinombolo ezinkulu kunesivivinyo sesigaba 1 (100-500)
Isigaba 3	Lesi sigaba siqhathanisa umuthi omusha noma ukwelashwa nokwelashwa kwamanje	Inani elikhulu labahlanganyeli elibhalisiwe (ngaphezu kuka-300+)
Isigaba 4	Uma umuthi usugunyaziwe ukuthi usetshenziswe lezi zinhlolo ziklanyelwe ukuqapha ukusebenza komuthi ogunyaziwe esintwini jikelele	Inani elikhulu kakhulu labahlanganyeli

I-randomisation isho ukuthini?

Uma izivivinyo ziqhathanisa imithi yokwelapha ephikisanayo ngokuvamile kuvame ukuhlola okungahleliwe. Lokhu kusho ukuthi uma usuvumile ukungena esivivinyweni, ikhompuyutha izokunikeza ngokungahleliwe kwenye yezindlela zokwelapha. Izindlela zokwelapha zivame ukubizwa ngokuthi "izingalo zokwelapha"

Wena noma udokotela wakho anikwazi ukukhetha ukuthi iyiphi ingalo yokwelapha owabelwe. Le nqubo isetshenziselwa ukuqinisekisa ukuthi ukuhlolwa kunobulungiswa nokuthi imiphumela evela eqenjini ngalinye ingafaniswa ngokwesayensi.

Kusho ukuthini ukuphuphuthekisa?

Ukungaboni kubhekisela esenzweni sokufihla uhlobo lokwelashwa olutholwa umhlanganyeli. Ukungaboni kusetshenziswa kwezinye izivivinyo ukuze ababambiqhaza bangazi ukuthi yikuphi ukwelashwa okutholwayo. Lokhu kwaziwa njengesivivinyo esiyimpumputhe. Ocwaningweni lomtholampilo oluphuphuthekile, ababambiqhaza abazi ukuthi iyiphi ingalo yocwaningo abakuyo. Inhloso yokuphuphuthekisa ukunciphisa ukuchema ekubikeni ngezinzuzo nemiphumela engemihle.

Iyini i-placebo?

I-placebo umuthi ongasebenzi noma oyinhlekisa. Yenziwa ukuthi ibukeke, inambithe noma izwakale sengathi ukwelashwa kuyahlolwa. Umehluko ukuthi ayinazo izithako ezisebenzayo. I-placebo isetshenziselwa ukuqinisekisa ukuthi imiphumela ingenxa yokwelashwa kwangempela. Uma i-placebo isetshenziswa, izoba ngaphezu kokwelashwa okujwayelekile. Awunawo ukwelashwa kwe-placebo ngokwakho. Isibonelo ungathola ukwelashwa okujwayelekile kanye nokwelashwa kokuhlola. Ungathola ukwelashwa okujwayelekile kanye ne-placebo.

Uyohlale utshelwa uma ukuhlola okuso kusebenzisa ama-placebo. Ngeke utshelwe uma uthola ukwelashwa kokuhlolwa noma i-placebo.

UDkt Michael Dickinson, Peter MacCallum Cancer Center

Kwenzekani ocwaningweni lomtholampilo?

Ukuhlolwa komtholampilo kwenziwa ngokohlelo olusethiwe noma iphrothokholi. Umthetho olandelwayo ubeka ukuthi yiziphi iziguli ezingabhaliswa ocwaningweni, yiziphi izivivinyo ezidingekayo, ukwelashwa okunikezwayo nokuthi yikuphi ukulandelelwa okudingekayo. Ungafunda kabanzi mayelana nokuthi yini engenzeka uma ubhalisa esivivinyweni somtholampilo.

Isho ukuthini imvume enolwazi?

Ngaphambi kokuthi noma ubani abhaliswe esivivinyweni somtholampilo, kufanele asayine ifomu lemvume. Le nqubo ibaluleke kakhulu. Ukubamba iqhaza kuwukuzithandela ngokuphelele. Akekho umuntu okufanele aphoqwe noma acindezelwe ukuthi abambe iqhaza ocwaningweni lomtholampilo. Odokotela nethimba lezivivinyo zemitholampilo lizokuchazela ngokuningiliziwe ngokuhlolwa komtholampilo. Bazoqinisekisa ukuthi unephepha lolwazi elibhaliwe. Uzonikezwa isikhathi esiningi sokufunda ulwazi futhi ucabange ukuthi ungathanda yini ukubamba iqhaza. Kubalulekile ukuthi uqonde kahle ukuthi yini ehilelekile okuhlanganisa izinzuzo nezingozi zokubamba iqhaza. Ezinye izivivinyo zomtholampilo zingadinga ukuthi ube nokuqokwa okwengeziwe kanye nokuhlolwa. Konke lokhu kuzochazwa futhi kuzoba ephepheni lolwazi. Ungathatha isikhathi sokuxoxa ngalokhu nomndeni wakho, abangani noma udokotela wakho womndeni. Akudingekile ukuba ubambe iqhaza ocwaningweni lomtholampilo. Kuyisinqumo sakho ngokuphelele futhi odokotela bakho bayakuqonda uma ungafuni ukubamba iqhaza. Uma unquma ukungabambi iqhaza uzothola ukwelashwa kwamanje okukhona kuwe.

Uma usunqume ukubamba iqhaza, uzodinga ukusayina ifomu lemvume. Lokhu kwenziwa nodokotela wakho

Kusho ukuthini ukufaneleka kokuhlolwa komtholampilo?

Uma usuvumile ukubamba iqhaza futhi ususayine ifomu lemvume, uzoqala inqubo yokuqinisekisa ukuthi ukuqulwa kwecala kukufanele. Lokhu kwaziwa njengokuqedela imibandela yokufaneleka. Lezi yizidingo okumele kuhlangatshezwane nazo, ukuze kuqinisekiswe ukuthi abantu ababambe iqhaza bayafana ngangokunokwenzeka. Uma ukuhlola kungafaneleki ngenxa yokuthi awuhlangabezani nokufaneleka, udokotela wakho uzoxoxa nawe ngezinye izinketho.

Ukwelashwa

Uma zonke izindlela zokufaneleka sezihloliwe futhi uma ukuhlola kukufanele, uzokwabelwa iqembu lokwelapha. Ngesikhathi sokwelashwa uzovakashela isibhedlela njalo ukuze uthole ukwelashwa nokuhlolwa. Kungase kudingeke wenze ukuvakasha okwengeziwe futhi ube nokuhlolwa okwengeziwe. Kungase kudingeke futhi uphendule imibuzo mayelana nendlela ozizwa ngayo. Iziqondiso zizochazwa udokotela wakho nonesi. Ulwazi luseshidini lolwazi olitholile ngaphambi kokuvuma ukuqulwa kwecala. Kubalulekile ukuthi ulandele yonke imiyalelo oyinikwayo futhi uma unemibuzo thintana nodokotela noma unesi wakho.

Ukunakekelwa kokulandelela

Uma usuqedile ukwelashwa kwakho, ungena esigabeni esaziwa ngokuthi ukulandelela. Uzobonwa udokotela wakho kanye nonesi futhi kungase kudingeke wenze ukuhlolwa okwengeziwe. Isibonelo, ukuhlolwa kwegazi, ukuhlolwa kwenhliziyo noma uhlu lwemibuzo.

Ukuhoxa esivivinyweni somtholampilo

Uma unquma ukuthi awusafuni ukuzibandakanya nokuhlolwa komtholampilo ungaphuma noma nini, ngaphandle kwencazelo. Ngeke ujeziswe ngalokhu. Uma uhoxisa imvume yakho, uzothola ukwelashwa okujwayelekile okuyiyona ndlela engcono kakhulu kuwe njengamanje.

Ungasithola kanjani isilingo somtholampilo?

Udokotela wakho uzokwazi ngezinhlolo zomtholampilo ezikufanele. Uma udokotela wakho engakhulumi nawe mayelana nokuhlolwa kwemitholampilo futhi unesithakazelo sokubamba iqhaza, ungabuza udokotela wakho uma kukhona okutholakalayo. Ungabuza futhi ukuthi zikhona yini izivivinyo kwezinye izibhedlela ozimisele ukuya kuzo. Udokotela wakho ngeke acasuke uma ubuza.

Kunezindawo ezimbalwa ongathola kuzo mayelana nokuhlolwa komtholampilo;

Ithimba lezokwelapha

Isinyathelo sokuqala ukukhuluma nodokotela wakho mayelana nezinketho ongakhetha kuzo. Udinga ukubuza ukuthi sikhona yini isilingo somtholampilo esikulungele wena. Udokotela wakho ukwazi kahle wena nomlando wakho wezokwelapha. Ngokuvamile bazokwazi uma kukhona okufanelekile esibhedlela sakho, endaweni yakho naphakathi kwezifunda. Uma bengazi ngokuthi yiziphi izivivinyo zomtholampilo ezitholakalayo, bangabuza abanye odokotela e-Australia uma benolwazi ngocwaningo.

Umbono wesibili

Enye inketho ukucela umbono wesibili nomunye udokotela. Iziguli eziningi zicela umbono wesibili. Odokotela abaningi banethezekile nalokhu, ngakho ungakhathazeki ngokubacasula. Odokotela abaningi bayaqonda ukuthi impilo yakho ibalulekile futhi udinga ukuzizwa ukhululekile ukuthi ubuze yonke imibuzo efanele futhi wazi izinketho zakho.

I-ClinTrial Refer

Lena iwebhusayithi yase-Australia eyenzelwe ukwandisa ukubamba iqhaza ocwaningweni lwesivivinyo somtholampilo. Itholakala kuzo zonke iziguli, zonke izinhlolo, bonke odokotela. Inhloso ukuthi:

Qinisa amanethiwekhi ocwaningo
Xhumana nama-referrals
Ukushumeka ukuhlanganyela kwezilingo njengendlela yokwelashwa
Ukwenza umehluko emsebenzini wocwaningo lwezokwelapha
Kukhona nenguqulo yohlelo lokusebenza

I-ClinicalTrials.gov

I-ClinicalTrials.gov iyisizindalwazi sezifundo zemitholampilo ezizimele nezixhaswa esidlangalaleni ezenziwa emhlabeni wonke. Iziguli zingathayipha ohlotsheni lwazo lwe-lymphoma, ukuhlola (uma kwaziwa) kanye nezwe lazo futhi kuzobonisa ukuthi yiziphi izinhlolo ezikhona njengamanje.

I-Australasian Leukemia & Lymphoma Group (ALLG)

ALLG nezivivinyo zomtholampilo
Kate Halford, ALLG

I-Australasian Leukemia & Lymphoma Group (ALLG) yiqembu lase-Australia kanye neqembu laseNew Zealand elingenzi nzuzo kuphela locwaningo lomtholampilo wegazi. Iqhutshwa injongo yabo 'Ukwelashwa Okungcono...Izimpilo ezingcono', i-ALLG izibophezele ekwenzeni ngcono ukwelashwa, izimpilo kanye namazinga okuphila eziguli ezinomdlavuza wegazi ngokuziphatha kocwaningo lomtholampilo. Ukusebenza ngokubambisana nongoti bomdlavuza wegazi kuleli nakwamanye amazwe, umthelela wabo ujulile. Amalungu angodokotela begazi, nabacwaningi abavela kulo lonke elase-Australia abasebenza nozakwabo emhlabeni jikelele.

Ucwaningo Lomdlavuza Wegazi eNtshonalanga Australia

A/Prof Chan Cheah, Sir Charles Gairdner Hospital, Hollywood Private Hospital & Blood Cancer WA

I-Blood Cancer Research Center yaseNtshonalanga Australia, igxile ocwaningweni lweLeukemia, iLymphoma kanye neMyeloma. Inhloso yabo ukunikeza iziguli ze-WA ezinomdlavuza wegazi ukufinyelela ekwelashweni okusha okungenzeka okusindisa impilo, ngokushesha.
Ukuhlolwa komtholampilo kuyindlela engcono kakhulu yokufeza lokhu futhi kwenziwa ezindaweni zethu ezintathu zasePerth, iSibhedlela i-Sir Charles Gardiner, i-Linear Clinical Research kanye ne-Hollywood Private Hospital.

Izivivinyo Zomdlavuza e-Australia

Le webhusayithi iqukethe futhi inikeza ulwazi olubonisa izivivinyo zakamuva zomtholampilo ekunakekelweni komdlavuza, okuhlanganisa izivivinyo okwamanje ezinxenxa ababambiqhaza abasha.

Peter MacCallum Isikhungo Somdlavuza

I-Peter MacCallum Cancer Centre iyisikhungo somdlavuza esisezingeni lomhlaba. Bayisikhungo esikhulu kunazo zonke socwaningo lomdlavuza e-Australia esinabasebenzi baselabhorethri abangaphezu kuka-750 kanye nabacwaningi bomtholampilo. Ungathola okwengeziwe mayelana nezivivinyo zabo zomtholampilo kanye nokufaneleka kwakho kuwebhusayithi yabo.

I-Australian New Zealand Clinical Trials Registry

I-Australian New Zealand Clinical Trial Registry (ANZCTR) iwukubhaliswa okuku-inthanethi kwezivivinyo zomtholampilo ezenziwa e-Australia, eNew Zealand nakwezinye izindawo. Vakashela iwebhusayithi ukuze ubone ukuthi yiziphi izivivinyo eziqashwayo njengamanje.

Ukubambisana kweLymphoma

I-Lymphoma Coalition, inethiwekhi yomhlaba wonke yamaqembu eziguli ze-lymphoma, yasungulwa ngo-2002 futhi yahlanganiswa njengenhlangano engenzi nzuzo ngo-2010. Inhloso yayo ecacile ukudala inkundla yokudlala yolwazi emhlabeni wonke kanye nokwenza lula umphakathi wezinhlangano zeziguli ze-lymphoma. ukusekela imizamo yomunye ekusizeni iziguli ezine-lymphoma zithole ukunakekelwa nokusekelwa okudingekayo.

Isidingo sehhabhu elimaphakathi lolwazi lwamanje olungaguquki kanye noluthembekile saqashelwa kanye nesidingo sezinhlangano zeziguli ze-lymphoma ukwabelana ngezinsiza, izinqubo ezingcono kakhulu, nezinqubomgomo nezinqubo. Ngalokhu engqondweni, izinhlangano ezine ze-lymphoma zaqala i-LC. Namuhla, kunezinhlangano ezingamalungu angama-83 ezivela emazweni angama-52.

Uma uthola isilingo ongathanda ukusijoyina, buza udokotela wakho ukuthi uyahlangabezana yini nemibandela yokufaneleka, uma kunjalo, ukuthi angakuxhumanisa yini ukuzibandakanya kwakho noma axhumane nethimba locwaningo.

Yiziphi izinzuzo zokubamba iqhaza ocwaningweni lomtholampilo?

Inzuzo enkulu yokubamba iqhaza ocwaningweni lomtholampilo ukuthi abantu bangathola ukwelashwa okusha okungakatholakali ukuze kwenziwe umtholampilo, noma izindlela zokwelapha ezikhona ezingatholakali ngenxa yezimo zabo. Isibonelo, uma umuntu ethole ukwelashwa okujwayelekile kohlobo oluthile lwe-lymphoma futhi engakayitholi impendulo ayeyifisa, ukuhlolwa komtholampilo kungase kube inketho enhle. Ukwelashwa kophenyo akutholakali kubantu abangaphandle kokuhlolwa komtholampilo. Ukuze ukwelashwa kunikezwe abantu base-Australia, kufanele ukuthi kuhlolisiswe ngokuqinile futhi kwahlolwa, futhi kufanele kugunyazwe i-Therapeutic Goods Administration (TGA). I-TGA indikimba kahulumeni ehlola futhi iqaphe zonke izimpahla zokwelapha ukuze iqinisekise ukuthi zisezingeni elamukelekayo ngaphambi kokuba zitholakale emphakathini wase-Australia.

Yiziphi izingozi zokubamba iqhaza ocwaningweni lomtholampilo?

Kufanele wazi ubungozi ngaphambi kokuba ubambe iqhaza ocwaningweni lomtholampilo. Zihlanganisa:

Ukwelashwa kungase kube ubuthi kangangokuthi ungase ube nemiphumela emibi kakhulu noma engaziwa
Ukwelashwa kungase kubonakale kungasebenzi kahle kunezokwelapha ezivamile futhi kunikeze inzuzo encane noma ingabi nalutho
Ungase ube seqenjini elilawulayo lokuhlolwa komtholampilo futhi ngenxa yalokho ungathola ukwelashwa kwe-lymphoma okujwayelekile hhayi ukwelashwa kokuhlola.

Imibuzo okufanele uyibuze udokotela wakho

Iyini inhloso yalolu cwaningo lomtholampilo?
Lolu cwaningo luzothatha isikhathi esingakanani?
Ngabe ngizoba ngcono ngokuba sesifundo?
Isifundo singayithinta kanjani impilo yami yansuku zonke?
Ingabe kuzoba nezindleko zokuthi ngibe sesifundo?
Ingabe wonke umuntu onesifo sami uyakufanelekela lokhu kuhlolwa?
Uma ngibamba iqhaza ocwaningweni, ngeke ngikuthole ukwelashwa okungcono kakhulu okutholakalayo?