clinical trialssafety and临床试验安全性.pdfVIP

CLINICALTRIALS:

SAFETYANDPHARMACOVIGILANCE

Dieillalón

Patientadvocate.Socialworker

MÁSQUEIDEASFoundation.LungCancerEurope(LuCE)

EUROPEANLUNGCANCERCONGRESS2019

DISCLOSUREINFORMATION

MÁSQUEIDEASFoundationisanonprofitorganizationwhoseactivitiesarefundedbybalancedsupportfrom

individuals,NGOandcompanies,someofthemfrompharmaceuticalindustry:

ASLAS,ASTRAZENECA,BAYER,BOEHRINGERINGELHEIM,BOSTONSCIENTIFIC,BRISTOLMYERS-SQUIBB,

CELGENE,GILEAD,IPSEN,KYOWAKIRIN,LILLY,MEDTRONIK,MERCK,MSD,MYLAN,NOVARTISONCOLOGY,

PFIZER,TAKEDA.

EUROPEANLUNGCANCERCONGRESS2019

Qualityoflifematterstopatients

-QoLisaverycomplexconcept

“Donotbelievethatitisalwayspossibletospeak

aboutcomplicatedthingsinasimpleway…Ifitis

complicated,thenitiscomplicated.”N.Amosov

-Prioritiesandpreferencesareuniquefor

each

-Eachpatientiswillingtotakeadifferent

levelofrisk

EUROPEANLUNGCANCERCONGRESS2019

ImprovingQoLisoneofthemainpatientmotivatorsforparticipatingin

medicalresearch.

SafetyandQoLarealwaysapriorityinCTbut...

•howcanweknowwhatismorerelevantforpatients?

•howcanweknowtherealimpactofatreatment?

EUROPEANLUNGCANCERCONGRESS2019

HOWCANWEKNOWWHATISMORE

RELEVANTFORPATIENTSAFETY?

Symptomatictoxicitiesofanticancertreatmentsisusuallynotbasedondirect

reportbypriorpatients,butinsteadonreportsmadebyclinicianassessment

inclinicaltrial

BaschE,BetA,PietanzaMC:Useofpatient-reportedoutcomestoimprovethepredictiveaccuracyofclinician-

reportedadverseevents.JNatlCancerInst103:1808-1810,2011