Ta Yaya Za Ka Sami Amfani da Druguri Mai Jin Kai na Binciken Nazari?
Me ake nufi da amfani da miyagun ƙwayoyi masu tausayi don marasa lafiya marasa lafiya? Yi tunani game da waɗannan tambayoyi:
Menene ya faru idan akwai nazari daya kawai wanda zai iya taimaka maka, amma baza ka sadu da bukatun gwaji na gwaji ba? Mene ne idan kun gaza duk wasu jiyya marasa lafiya sai dai don magani mai ban sha'awa wanda FDA bai amince ba?
Lokacin da wannan ya auku, FDA yana da tsarin tsare-tsare a wuri. Wannan ana kiran shi kyautar jin dadi ko kuma fadada damar yin amfani da kwayoyin bincike.
Menene Ma'ana da Manufar "Yin Amfani da Tafiyar tausayi?"
Amfani da miyagun ƙwayoyi mai tausayi yana nufin amfani da kwayoyi masu bincike (magani na gwaji) ko na'urar kiwon lafiya (wanda bai riga ya amince da ita ba) a waje na gwaji don magani idan babu wani magani mai mahimmanci. Kafin amincewar FDA, ba za a iya sayar ko sayar da kwayoyi ba a Amurka.
Mene ne Sabuwar Magunguna Bincike (IND)? - Bincike game da gwaje-gwaje na Clinical da kuma aiwatar da FDA Approval
Kafin tattaunawa game da amfani da miyagun ƙwayoyi masu tausayi, zai iya taimakawa wajen dawo da bayanin sababbin magungunan miyagun ƙwayoyi ko yadda ake aiwatar da ita, kuma a ƙarshe ko dai an ƙi ko amincewa da tsari na FDA don amfanin jama'a. Don wannan tattaunawar, zan ƙaddamar da tsarin zuwa magunguna kadai.
Mataki na farko da masu bincike suke amfani dasu yayin da suke nazarin magani mai yiwuwa zasu shafi nazarin mutum ba. Sabbin magunguna a cikin wannan wuri ana gwada su ko dai kwayoyin cutar kanjamau sun girma a cikin tasa a cikin Lab, ko a kan wasu dabbobi, irin su mice. Lokacin da ake nazarin waɗannan binciken cikakke cikakke, gwajin mutum yana zuwa ta hanyar kashi uku na gwajin gwaji .
Ana gudanar da bincike na asibiti na farko a kan ƙananan yawan mutane, kuma an tsara su don amsa wannan tambaya: "Shin maganin lafiya ne?" Sakamakon gwaji na biyu shine matakai na gaba, an tsara su don amsa wannan tambaya: "Shin magani yana aiki?" Mataki na karshe kafin amincewar FDA (ko kin amincewa) shi ne lokaci na 3 gwaji na gwaji, gwajin da aka yi amfani da ita don amsa wannan tambayar: "Shin magani ya fi aiki fiye da yadda aka yarda da maganin, ko kuma tare da rashin illa?"
Yin amfani da wannan labari, amfani da miyagun ƙwayoyi masu tausayi zai zama amfani da magani wanda yake cikin wani ɓangare na binciken binciken asibiti kafin yarda da FDA, amma ba a matsayin ɗan takara a daya daga cikin gwajin gwaji ba.
Yayinda Mutum zai iya Yiwa Yin Amfani da Druguri (Mai Amfani da Mai Amfani da Mai Jin Kai)?
Mafi mahimmanci, marasa lafiya na ciwon daji da zasu iya amfanar da sababbin kwayoyi (IND) za su shiga cikin jarrabawar gwaji da ke nazarin wannan magani . Wannan ya ce, wasu mutane da zasu iya amfani da kwayoyi da ake nazari bazai dace da takamaiman ka'idoji don shigar da su a wannan gwaji don dalilan da suka shafi shekarun haihuwa, magani na baya ba, halin aiki, ko wasu ban da yanayin. A wannan yanayin, dole ne a cika ka'idojin 2:
- Dole ne babu wata matsala mai mahimmanci da za a iya ganowa, saka idanu, ko magance wata cuta mai tsanani, kuma
- Rashin haɗari ga mutum daga kwayoyin bincike (ko tsari) ba mafi girma daga hadari mai yiwuwa daga cutar kanta ba.
Mene ne Ƙarin Riga ga Drugs Nazarin?
Idan ka karanta ta takardun FDA, zaka iya mamaki ko abin da bambancin yake tsakanin damar da aka haɓaka da kuma amfani da jinƙai, ko kuma idan an yi amfani da su a tsakanin juna. Amsar ita ce, akwai kashi 3 na samun damar fadada, tare da farko da ake nufi don amfani da mutum haƙuri. Wadannan sassan sun hada da:
- Yin amfani da kwayoyin bincike don marasa lafiya
- Tsarin marasa lafiya na matsakaici (har zuwa 100), kuma
- Ƙungiyoyin marasa lafiya (fiye da 100)
Bukatun Gudanar da Cibiyar Nazarin Harkokin Cutar Kwayoyin Wuta
Dole ne a sadu da waɗannan sharuɗɗa don biyan bukatun mutum:
- Da miyagun ƙwayoyi (ko tsari) dole ne ya kasance don ganewar asali, saka idanu, ko magani na rashin lafiya mai tsanani.
- Dole ne mai haƙuri ya kasance ba shi da cancanta ga gwajin gwaji na magani.
- Dole ne FDA ta ƙayyade cewa ƙetarewar amfani da tausayi bazai tsangwama tare da kowane mataki na gwaji na gwaji na miyagun ƙwayoyi ba.
- Dole ne babu wata mahimmanci mai dacewa ko magani mai dacewa ga mai haƙuri, ko mai haƙuri ba zai iya jure wa wadannan hanyoyin maganin ba.
- Dole ne mai haƙuri ya kasance da ganewar cutar daji wanda abin da kwayar cutar ta gano ya nuna aiki. A wasu kalmomi, dole ne FDA ta ƙayyade cewa akwai cikakkun shaidar cewa miyagun ƙwayoyi suna da lafiya kuma suna da tasiri don tabbatar da amfani da shi ga wani mai haƙuri.
- Dole ne mai yin haƙuri ya yi la'akari da magani wanda bai dace ba.
- Dole ne a yi amfani da miyagun ƙwayoyi don mummunan yanayi, ko yanayin rayuwa mai hadarin gaske, inda ƙalubalen gwajin gwaji ya wuce hadarin rashin karɓar magani. A wasu kalmomi, haɗarin, ciki har da mutuwa, na gwajin gwaji ya zama ƙasa da hadarin mutuwa daga cutar ba tare da magani ba.
- Samun maganin miyagun ƙwayoyi ya ƙunshi haɗin maƙasudin likita da haƙuri
- Dole likita ya kasance yana son gudanar da miyagun ƙwayoyi kuma ya cika saka idanu
- Kamfanin da ya sa likita ya yarda ya ba da magani (FDA ba zai iya "tilasta" kamfanin ya ba da miyagun ƙwayoyi ba.) Idan kamfanin yana buƙatar biyan bashin magani, mai haƙuri dole ne ya bada wannan bashin.
- FDA, bayan karɓar aikace-aikacen, zai yanke shawarar ko yakamata izinin amfani da tausayi. Yana da mahimmanci a lura cewa yayin da wannan ya yi kama da wata matsala mai wuya, tun daga shekara ta 2009 FDA ta amince da mafi rinjaye idan bincike na sababbin aikace-aikace na miyagun ƙwayoyi ya karɓa .
Aikace-aikacen Aikace-aikace don Amfani da Druguri Mai Jin Kai
Akwai nau'i biyu na aikace-aikace don amfani da tausayi. Wadannan sun haɗa da:
- Amfani na gaggawa - A halin da ake ciki na gaggawa ana iya yin buƙatar ta hanyar tarho (ko wasu hanyoyin sadarwa mai sauri) kuma jami'in FDA zai iya ba da damar izinin wayar don farawa. Dole ne mai kula da likita ya biyo bayan wannan izini tare da aikace-aikacen yin amfani da maganin miyagun kwayoyi da aka rubuta a cikin kwanaki 15 na izinin FDA don amfani da miyagun ƙwayoyi. (Idan babu lokacin da za a sami amincewa daga hukumar bincike na binciken (IRB) a yanayin da ake ciki, za a iya fara magani idan ba a amince da IRB ba har lokacin da likitan ya sanar da lafiyar gaggawa a cikin kwanaki biyar na aiki.)
- Amfani da tausayi (Gudanar da Samun Bincike) - Sai dai idan akwai gaggawa na barazanar rayuwa, likita mai kulawa ya kamata ya kammala bincike kan sababbin aikace-aikacen amfani da miyagun ƙwayoyi. Da zarar an aika wannan aikace-aikacen zuwa ga FDA, FDA na da kwanaki 30 a lokacin da za'a iya nazarin aikace-aikacen kuma yanke shawara akan karɓa ko ƙin yarda. Ka tuna cewa mafi yawan lokutan, za a raba shawara tare da likitan mai magani a cikin sauri.
(Tun lokacin da wannan bayanin ya sauya tare da lokaci, duba tushen FDA da aka jera a kasan wannan labarin don mafi yawan bayanai.)
Abin da Kuna Bukatar Ku sani A Matsayi Mai haƙuri
Akwai abubuwa da dama da za ku tuna idan kuna la'akari da yin amfani da kwayoyi masu bincike. Wadannan sun haɗa da:
- Da miyagun ƙwayoyi (ko tsari) na iya zama haɗari mai tsanani.
- Tun da FDA ba ta rigaya ta amince da miyagun ƙwayoyi (ko hanyar) ba, ba a san idan likitan bincike ba ya fi kyau ko ya fi muni. Kuna iya karɓar wani ƙarin amfani daga miyagun ƙwayoyi.
- Hakanan har yanzu ba a san cikakken maganganun da ke cikin gajeren lokaci ba da kuma sakamako mai tsawo na miyagun ƙwayoyi.
Matsayinka na Doctor a Amfani da Druguri Mai tausayi
Yayin da ake buƙatar amfani da miyagun ƙwayoyi masu jin tausayi, zai zama magungunan likitancinka (wanda kake ganin kanka don kulawa) wanda ke da alhakin aikace-aikace, gwamnati, da kuma takardun magani.
- Dole ne likita mai kulawa ya cika aikin kamar yadda aka bayyana a sama.
- Likitaccen likitan zai zama alhakin mika wuya ga yarjejeniyar magancewa da kuma tabbatar da FDA tare da rahoto na sakamako na magani, taƙaitaccen bayani, da kuma duk wani sakamako mai tasiri.
- Likita mai kulawa yana da alhakin samun magani daga masu sana'a / mai dasu, kuma don asusun duk wasu magungunan da suka rage idan an gama yin magani.
- Dole ne likita mai kulawa ya yarda ya saka idanu a duk lokacin da yake jiyya, bi duk jagororin da kuma alhakin da yake ɗauka a matsayin mai bincike na wannan mai haƙuri.
Sources:
Cibiyar Cancer ta Kasa. Samun damar maganin kwayoyi. Updated 08/04/09. https://www.cancer.gov/about-cancer/treatment/drugs/investigational-drug-access-fact-sheet
Cibiyar Abinci da Druggun Amurka (FDA). Ƙara Rarraba (Amfani da Mai Amfani). Updated 02/09/16. http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20080392.htm
Cibiyar Abinci da Druggun Amurka (FDA). Ƙara Jagora: Bayani ga Magunguna. Updated 03/03/16. http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm
Cibiyar Abinci da Druggun Amurka (FDA). Ƙara Jagora: Bayani ga likitoci. Updated 12/15/15. http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm429624.htm
Cibiyar Abinci da Druggun Amurka (FDA). IDE Early / Expanded Access. Updated 03/26/15. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm