Kodi Mungatani Kuti Mukhale ndi Chidwi Chogwiritsira Ntchito Mankhwala Osokoneza Bongo?
Kodi kutanthauzanji kugwiritsa ntchito mankhwala osokoneza bongo kwa odwala khansa? Ganizirani mafunso awa:
Nchiyani chimachitika ngati pali njira imodzi yokha yophunziridwa yomwe ingakuthandizeni, koma simukumana ndi zofunikira zowunikira odwala? Bwanji ngati mwalephera mankhwala ena onse kupatulapo chithandizo cholonjeza chomwe sichinavomerezedwe ndi FDA?
Izi zikachitika, a FDA ali ndi ndondomeko yosungiramo zinthu. Izi zimatchedwa kusagwiritsidwa ntchito mwachifundo kapena kupititsa patsogolo mwayi wopita kuchipatala.
Kodi Cholinga ndi Cholinga cha "Kugwiritsa Ntchito Mankhwala Opanda Chifundo" ndi Chiyani?
Kugwiritsira ntchito mankhwala osokoneza bongo kumatanthauza kugwiritsira ntchito mankhwala osokoneza bongo (mankhwala osokoneza bongo) kapena chipangizo chachipatala (omwe sichinavomerezedwe ndi FDA) kunja kwa kuyezetsa kwachipatala ngati palibe mankhwala ena othandiza omwe alipo. Pambuyo pa kuvomereza kwa FDA, mankhwala osokoneza bwenzi sangagulitsidwe kapena kugulitsidwa ku United States.
Kodi Investigational New Drug (IND) ndi chiyani? - Kufotokozera za Clinical Trials ndi ndondomeko ya kuvomereza kwa FDA
Musanalankhule za kugwiritsa ntchito mankhwala osokoneza bongo, zingathandize kumbuyo ndi kufotokozera njira yatsopano ya mankhwala kapena ndondomeko yomwe ikupangidwira, ndipo pamapeto pake amakanidwa kapena kuvomerezedwa ndi njira yovomerezeka ya FDA yogwiritsidwa ntchito ndi anthu onse. Pa zokambiranazi, ndikuletsa kumwa mankhwala okha.
Otsatira ochita kafukufuku akugwiritsa ntchito pofufuza momwe mankhwala angapangidwire omwe amaphatikizapo maphunziro osakhala aumunthu. Mankhwala atsopano pachikhalidwe ichi amayesedwa pa maselo a khansa omwe amakhala mu mbale mu labu, kapena pa zinyama zina, monga mbewa. Pamene maphunzirowa akuwonedwa mokwanira, kuyesedwa kwaumunthu kumadutsa magawo atatu a mayesero a zamankhwala .
Maphunziro oyambirira a Gawo 1 amachitika pa anthu ang'onoang'ono, ndipo apangidwa kuti ayankhe funso: "Kodi mankhwalawa ndi otetezeka?" Mayesero a Gawo 2 ndi sitepe yotsatira, yokonzedwa kuti ayankhe funso: "Kodi mankhwalawa akugwira ntchito?" Gawo lomalizira lisanayambe kuvomerezedwa ndi FDA (kapena kukanidwa) ndi mayesero a chipatala 3, mayesero ogwiritsidwa ntchito poyankha funso: "Kodi chithandizochi chikugwira ntchito bwino kuposa mankhwala ovomerezeka, kapena ndi zotsatira zochepa?"
Pogwiritsa ntchito vutoli, kugwiritsa ntchito mankhwala osokoneza bongo kungakhale kugwiritsa ntchito mankhwala omwe ali mu gawo limodzi la maphunziro achipatala pamaso pa chivomerezo cha FDA, koma osati monga gawo limodzi mwa mayesero a zachipatala.
Kodi Munthu Wina Angakwanitse Bwanji Kugwiritsa Ntchito Mankhwala Opanda Chifundo?
Ndibwino kuti, odwala khansa omwe angapindule ndi kufufuza mankhwala atsopano (IND) adzalembedwe mu mayeso ogwira ntchito omwe akuphunzira mankhwalawa . Izi zati, anthu ena omwe angapindule ndi mankhwala omwe akuphunzira nawo sangagwirizane ndi zofunikira zowunikira ku mayeso a chipatala chifukwa cha zaka, chithandizo cham'tsogolo, chikhalidwe cha ntchito, kapena zina zosagwirizana ndi zikhalidwe. Pachifukwa ichi, zoyenera 2 ziyenera kukumana:
- Sitiyenera kukhala mankhwala othandiza omwe angapezeke, kuwunika, kapena kuchiza matenda aakulu, ndi
- Vuto lotheka kuti munthuyo asatenge mankhwala osokoneza bongo (kapena ndondomeko) si wamkulu kuposa chiwopsezo chotheka kuchipatala chomwecho.
Kodi Kupititsa Kugwiritsa Ntchito Mankhwala Osokoneza Bongo Ndi Chiyani?
Ngati mukuwerenga kudzera mu zolemba za FDA, mungadabwe kuti kusiyana kotani kuli pakati pa kupititsa patsogolo mwayi wowonjezera ndi kuyanjidwa kwachisomo, kapena ngati kugwiritsidwa ntchito mosiyana. Yankho ndilokuti pali magawo atatu a mwayi wopititsa patsogolo, omwe akuyamba kugwiritsa ntchito munthu opirira.Azigawo izi zikuphatikizapo:
- Kugwiritsa ntchito mankhwala osanthula odwala
- Odwala omwe ali pakati pa anthu odwala (mpaka 100), ndi
- Magulu akuluakulu a odwala (oposa 100)
Zomwe Munthu Amafunika Kupeza Mankhwala Osokoneza Bongo kwa Khansa
Zotsatira zotsatirazi ziyenera kukumana kuti zigwiritse ntchito kwa munthu aliyense payekha:
- Mankhwala (kapena ndondomeko) ayenera kukhala ndi matenda, matenda, kapena mankhwala odwala.
- Wodwalayo ayenera kukhala wosagwirizana ndi mayesero alionse omwe amapita kuchipatala.
- A FDA ayenera kutsimikiza kuti kugwiritsa ntchito mwachifundo sikudzasokoneza gawo lililonse la mayesero opititsa patsogolo mankhwala.
- Sitiyenera kukhala ndi njira yodalirika yowonjezereka kapena yowonetsera yomwe ikupezeka kwa wodwalayo, kapena wodwala sangathe kulekerera njira zothandizira izi.
- Wodwala ayenera kukhala ndi matenda opatsirana khansa omwe mankhwala ofufuzira amasonyeza ntchito. Mwa kuyankhula kwina, a FDA ayenera kudziwa kuti pali umboni wokwanira kuti mankhwalawa ali otetezeka komanso ogwira mtima kuti agwiritse ntchito ntchito kwa wodwalayo.
- Wodwala ayenera kukhala atalandira chithandizo chamankhwala chomwe sichili bwino.
- Mankhwalawa ayenera kugwiritsidwa ntchito pa chiopsezo chachikulu kapena choopsya, chomwe chiopsezo cha chithandizo choyesera chikuposa kuopsa kwa kusalandira chithandizo. Mwa kuyankhula kwina, chiopsezo, kuphatikizapo imfa, ya chithandizo choyesera chimaonedwa kuti sichitha kupha imfa kuchokera kuchipatala popanda kuchipatala.
- Kupeza mankhwalawa kumaphatikizapo kutenga mbali kwa dokotala komanso wodwalayo
- Dokotala ayenera kukhala wokonzeka kugwiritsira ntchito mankhwalawa ndi kumaliza kayendedwe ka mankhwala
- Kampani yomwe imapangitsa mankhwalawo kuvomerezana kuti apereke mankhwala (a FDA sangathe "kulimbikitsa" kampaniyo kuti apereke mankhwalawa) Ngati kampani ikupempha kuti mulipereke mankhwala, wodwalayo ayenera kupereka malipiro awa.
- A FDA, atalandira pempholi, adzasankha kuti asalolere kugwiritsidwa ntchito mwachifundo. Ndikofunika kuzindikira kuti ngakhale izi zikuwoneka ngati zovuta, kuyambira 2009 a FDA avomereza ambiri ngati ntchito zowonongeka zamagetsi zalandira .
Njira Yothandizira Kugwiritsa Ntchito Mankhwala Opanda Chifundo
Pali mitundu iwiri ya mapulogalamu ogwiritsira ntchito chifundo. Izi zikuphatikizapo:
- Kugwiritsa Ntchito Mwadzidzidzi - Panthawi yovuta, pempho lingapangidwe kudzera pa telefoni (kapena kulankhulana mofulumira) ndipo wogwira ntchito ya FDA angapereke chilolezo pa telefoni kuti ayambe kumwa mankhwala. Dokotala wothandizira ayenera kutsata chilolezo cha mawuwa ndi zolembedwa zolemba ntchito zamagwiritsidwe ntchito kosokoneza bongo m'masiku 15 a chilolezo cha FDA chogwiritsa ntchito mankhwalawa. (Ngati palibe nthawi yokwanira yovomerezeka kuchokera ku kafukufuku wogwiritsa ntchito kafukufuku (IRB) panthawi yomwe ikuchitika, mankhwala angayambe popanda kuvomerezedwa kwa IRB malinga ngati IRB idziwitsidwa ndi dokotala yemwe akupereka chithandizo mwachangu masiku asanu ndi atatu ogwira ntchito.)
- Kugwiritsira ntchito chifundo (Wodwala Wopeza Matenda) - Pokhapokha ngati pangozi zowopsya, dokotala yemwe akuchiza ayenera kumaliza ntchito yatsopano yogwiritsa ntchito mankhwala. Pomwe pempholi laperekedwa kwa FDA, a FDA ali ndi masiku 30 pomwe ntchitoyi idzayang'aniranso ndi chisankho chovomerezedwa kapena kuvomereza. Kumbukirani kuti nthawi zambiri, chisankhocho chidzagawidwa ndi dokotala wodwala mofulumira.
(Popeza kuti chidziwitsochi chimasintha ndi nthawi, fufuzani ma fayilo a FDA omwe ali pansi pa nkhaniyi kuti mudziwe zambiri.)
Zimene Mukuyenera Kudziwa Ngati Wodwala
Pali zinthu zingapo zomwe muyenera kukumbukira ngati mukuganizira kugwiritsa ntchito mankhwala osokoneza bongo. Izi zikuphatikizapo:
- Mankhwala (kapena ndondomeko) akhoza kukhala ndi zoopsa zazikulu.
- Popeza mankhwala (kapena ndondomeko) sanagwirizane ndi a FDA, sizikudziwika ngati mankhwala openda opaleshoni ali abwino kapena oipitsitsa kuposa mankhwala osokoneza bongo. Simungalandire phindu lina la mankhwala.
- Zotsatira zazing'ono zazing'ono za zotsatira za mankhwalawa sizidziwikebe.
Udindo Wa Dokotala Wanu mu Kugwiritsa Ntchito Mankhwala Opanda Chifundo
Mukamapempha kugwiritsa ntchito mankhwala osokoneza bongo, ndiye kuti mudzakhala odwala oncologist (omwe mumadziona kuti ndinu osamala) amene adzakhale ndi udindo wothandizira, kulamulira, ndi zolemba za mankhwala.
- Dokotala wothandizira ayenera kudzaza pempho monga tafotokozera pamwambapa.
- Dokotala wothandizira adzakhala ndi udindo wotsatsa njira yothandizira mankhwala ndi kutsimikizira FDA ndi lipoti la zotsatira za mankhwala, chidule, ndi zotsatira zina.
- Dokotala wothandizira ali ndi udindo wopezera mankhwala kuchokera kwa wopanga / opanga mapulogalamu, ndikuwerengera mankhwala ena otsala mutatha mankhwala.
- Dokotala wothandizira ayenera kuvomereza kuyang'anitsitsa wodwalayo pakamwa, kutsatira zitsogozo zonse ndi maudindo pamene akugwira ntchito ya wofufuzira kwa wodwala uyu.
Zotsatira:
National Cancer Institute. Kupeza Mankhwala Osokoneza Bongo. Kusinthidwa 08/04/09. https://www.cancer.gov/about-cancer/treatment/drugs/investigational-drug-access-acact-sheet
US Food and Drug Administration (FDA). Kufikira Kufikira (Kugwiritsa Ntchito Chisomo). Kusinthidwa 02/09/16. http://www.fda.gov/NewsEvents/PublicHealthFocus/ExpandedAccessCompassionateUse/ucm20080392.htm
US Food and Drug Administration (FDA). Kufikira Kufikira: Zomwe Odwala Amadziŵa. Kusinthidwa 03/03/16. http://www.fda.gov/ForPatients/Other/ExpandedAccess/ucm20041768.htm
US Food and Drug Administration (FDA). Kufikira Kufikira: Chidziwitso kwa Amayi. Kusinthidwa 12/15/15. http://www.fda.gov/NewsEvents/PublicHealthFocus/ZowonjezedwaAccessCompassionateUse/ucm429624.htm
US Food and Drug Administration (FDA). IDE Yoyamba / Kufikira Kufikira. Kusinthidwa 03/26/15. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/InvestigationalDeviceExemptionIDE/ucm051345.htm