Research

Lungiselela ukubandakanywa kwelizwi lesigulane kunye nombono kwisizukulwana sedatha ephezulu

umsebenzi

Sizama ukuxhobisa imibutho yethu engamalungu kunye nabasebenzisana nabo ngokwabelana ngamava ethu abanzi kwiindlela zokuziphatha, ulingo lwezonyango, uphando lophando, amaqela ekugxilwe kuwo, kunye nezinye iinkalo zophando olugxile kwisigulane kunye nokuxhasa uphuhliso lonyango kunye noxilongo.

umbono

Ukunceda ukulungelelanisa kunye nokulungelelanisa imisebenzi yethu yentsebenziswano kunye nokwandisa ukubandakanywa kwelizwi lesigulane kunye nombono ekuveliseni idatha ephezulu 

“Musani ukumphulaphula lowo uneempendulo; mamela umntu onemibuzo. ”…
-Albert Einstein

Kubaphandi: Izakhono zoPhando ze-GAAPP

  • Iingcebiso zokucebisa: uyilo lwesilingo esigxile kwisigulana kunye neqhinga
  • Abathathi-nxaxheba bovavanyo, kunye nokukhangela abaphandi besigulane
  • Isigulana sehlabathi, abanakekeli kunye nomboneleli wezempilo (HCP) uyilo lovavanyo, ukuphunyezwa, uhlalutyo, kunye nokunika ingxelo
  • Amaqela ekugxilwe kuwo ekufuneni nasekuphunyezweni
  • Uyilo lokuphucula inkqubo kunye nokuphunyezwa
  • Igalelo kushicilelo (umbono wesigulane kunye nomnakekeli).
  • Ukulungiswa kunye nokusasazwa kweengxelo ezishwankathelayo (eziguqulelweyo).

Kwizigulane, abaNakekeli, kunye nabaBonekeli bezeMpilo: Indlela yokuBandakanya kuPhando

I-GAAPP kunye nemibutho yayo engamalungu iqesha izigulane, abanakekeli okanye ababoneleli ukuba bathathe inxaxheba kuphando lophando, iimvavanyo zeklinikhi, iiphaneli zeengcebiso, kunye namaqela ekugxilwe kuwo.

Oonozakuzaku abaxhaswa yi-GAAPP/abanononophelo banokwenza uphando:

  • Ukukhonza njengommeli wesigulane / umnakekeli kwiibhodi zeengcebiso zophando 
  • Ukuxhasa uphando olugxile kwisigulane ngokubonelela ngombono wesigulane / ukuphakamisa ilizwi lesigulane
  • Thatha inxaxheba kuvavanyo lwesigulane kunye nabachaphazelekayo ekuphuhliseni unyango, izixhobo zedijithali, kunye nezixhobo zonyango.

Izigulane kunye nabaphandi abanakekeli banokuba negalelo njani kulingo lwezonyango?

  • Phuhlisa umbuzo wophando kunye neziphumo zokufunda ezifanelekileyo 
  • Chaza iimpawu zabathathi-nxaxheba kuphando
  • Yila okanye uhlaziywe imathiriyeli yokufunda kunye nemigaqo
  • Thatha inxaxheba ekufuneni abathathi-nxaxheba kuphando
  • Thatha inxaxheba ekuqokeleleni idatha kunye nohlalutyo
  • Thatha inxaxheba kupapasho nakunxibelelwano

IziBonelelo zeMfundo kuPhando

Wamkelekile kuluhlu olucwangcisiweyo lwezixhobo ze-GAAPP eziyilelwe ukuxhasa ukusetyenziswa kwakho kophando lwethu kunye nezixhobo zokugaya abantu. Nceda uqhagamshelane nathi ku uphando@gaapp.org ngayo nayiphi na imibuzo okanye iingcebiso. 

Ulawulo lokutya kunye neziyobisi lwase-US lunezixhobo eziluncedo ekuzibandakanyeni kwesigulana: https://www.fda.gov/drugs/development-approval-process-drugs/cder-patient-focused-drug-development

I-European Federation of Pharmaceutical Industries and Associations (EFPIA) isikhundla malunga nokuzibandakanya kwezigulane: https://www.efpia.eu/media/676506/final-efpia-position-on-transparency-of-patient-evidence-in-regulatory-decision-making-and-product-information.pdf

Uvimba wemiba yeleta yeendaba yangaphambili: https://gaapp.org/newsletters/ 

Indlela Yokubandakanyeka Kuphando

Okwangoku amathuba okugaya: Amathuba okuFumana uPhando

Izifundo ezongezelelweyo zinokufunyanwa apha: Isixhobo sokuTshanisa izilingo zeklinikhi

Isixhobo sokuTshanisa izilingo zeklinikhi

I-GAAPP ibambisene "ne-Antidote" ukubonelela ngesixhobo esilula ukufikelela kunye nokuhambelana nolingo lwezonyango. Isixhobo asithatheli ingqalelo kuphela imeko yakho kodwa ilizwe kunye nesixeko apho uzinze khona. Izilingo zeklinikhi zifunyenwe kuzo zonke iinkcukacha ezifanelekileyo, kwaye inkqubo ye-60-yesibini ehambelanayo ibonisa ulwazi ngendlela elula ukuze zonke izigulane ziqonde. Funda nzulu

 Unokukhangela kwakhona ulingo lwezonyango kwindawo yakho www.ClinicalTrials.Gov