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DTSTART:20231002T020000
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BEGIN:VEVENT
DESCRIPTION:Time: 14:00 - 15:30 UK Time\n\nPresenters: Gaelle Saint-Hilary
and Stephanie Cadour\n\nClick here \;to view the presentation slides.\
n\nClick \;here \;for the programme and slides.\n\nAbstract\n\n\nS
everal quantitative methodologies have been proposed to support decision-m
aking in drug development. In particular\, MultiCriteria Decision Analysis
(MCDA) is a useful tool to assess the benefit-risk balance of medicines a
ccording to the performances of the treatments on several criteria\, accou
nting for the preferences of the decision-makers regarding the relative im
portance of these criteria. The EMA Benefit-Risk Methodology Project sugge
sted that it is one of the most comprehensive among the quantitative metho
dologies they considered\, and it is also recommended by several highly pr
ofiled expert groups. While MCDA requires the exact elicitation of the wei
ghts of the criteria according to the preferences of the decision-makers\,
extended versions of MCDA have been proposed\, such as Stochastic Multicr
iteria Acceptability Analysis (SMAA) and Dirichlet SMAA\, where the weight
s are considered as random variables to account for some uncertainty in th
e weight assignment. \nThis webinar proposes a very concrete illustration
of MCDA and of the extended models SMAA and Dirichlet SMAA using case-stud
ies. We will present how to derive a benefit-risk utility score for each t
reatment\, how to compare several treatments\, how to present the results
and how to conduct sensitivity analyses. The differences between the model
s will be highlighted\, and some R code will be presented and shared after
the presentation.\n\n\nAbout the Presenter: \;Gaelle Saint-Hilary\nGa
elle Saint-Hilary works in statistics for the pharmaceutical industry sinc
e 2006. She is currently completing a PhD on &ldquo\;Quantitative Decision
-Making in Drug Development&rdquo\;\, sponsored by Servier\, at the Polyte
chnic University of Turin (Italy). Before that\, she worked as biostatisti
cian in the industry\, first at Servier for 5 years and then at Novartis O
ncology for 4 years. She was responsible for the clinical development and
the licensing of medicinal products in neuropsychiatry and leukemia\, and
her main scientific interests were benefit-risk assessment\, network meta-
analyses\, multiple test procedures\, simulation models of time-to-event d
ata and survival analysis in presence of intercurrent events. The developm
ent and the promotion of quantitative methods for drug benefit-risk assess
ments is one of the major topics she considers during her PhD\, with the f
inal goal of enhancing decision-making throughout the drug life-cycle.&nbs
p\;\n\n\n\n\nAbout the Presenter: \;Stephanie Cadour\n\nGraduated in 2
011\, Sté\;phanie Cadour works as a biostatistician at Servier (Fran
ce) since then. She was initially responsible for the statistical aspects
of phase II and III clinical studies conducted in the therapeutic areas of
neuropsychiatry and diabetes. She is now working on early phase studies i
n the field of oncology. In parallel of these activities\, Stephanie devel
oped skills on meta-analyses as well as on quantitative approaches for ben
efit-risk assessment on which she has been working on since 2011.\n\n\n\nT
o access the recording\, please visit the Video-on-Demand Library.
DTEND:20180313T153000Z
DTSTAMP:20240328T095106Z
DTSTART:20180313T140000Z
LOCATION:
SEQUENCE:0
SUMMARY:PSI/EFSPI Webinar: Quantitative benefit-risk assessment using Multi
Criteria Decision Analysis (MCDA) and its extensions: practical applicatio
n
UID:RFCALITEM638472162670209497
X-ALT-DESC;FMTTYPE=text/html:Time: 14:00 - 15:30 UK Time\n
\nPresenters: Gaelle Saint-Hilary and Stephan
ie Cadour
\n
\nClick here \;to view the presentation slides.
\n
\nClic
k \;here \;for the pro
gramme and slides.
\n
\nAbstract
\n
\n\n
Several quantitative methodologies have been proposed to support dec ision-making in drug development. In particular\, MultiCriteria Decision A nalysis (MCDA) is a useful tool to assess the benefit-risk balance of medi cines according to the performances of the treatments on several criteria\ , accounting for the preferences of the decision-makers regarding the rela tive importance of these criteria. The EMA Benefit-Risk Methodology Projec t suggested that it is one of the most comprehensive among the quantitativ e methodologies they considered\, and it is also recommended by several hi ghly profiled expert groups. While MCDA requires the exact elicitation of the weights of the criteria according to the preferences of the decision-m akers\, extended versions of MCDA have been proposed\, such as Stochastic Multicriteria Acceptability Analysis (SMAA) and Dirichlet SMAA\, where the weights are considered as random variables to account for some uncertaint y in the weight assignment.
\nThis webinar proposes a very concrete illustration of MCDA and of the extended models SMAA and Dirichlet SMAA u sing case-studies. We will present how to derive a benefit-risk utility sc ore for each treatment\, how to compare several treatments\, how to presen t the results and how to conduct sensitivity analyses. The differences bet ween the models will be highlighted\, and some R code will be presented an d shared after the presentation.
\nGaelle Saint-Hilary works in sta tistics for the pharmaceutical industry since 2006. She is currently compl eting a PhD on &ldquo\;Quantitative Decision-Making in Drug Development&rd quo\;\, sponsored by Servier\, at the Polytechnic University of Turin (Ita ly). Before that\, she worked as biostatistician in the industry\, first a t Servier for 5 years and then at Novartis Oncology for 4 years. She was r esponsible for the clinical development and the licensing of medicinal pro ducts in neuropsychiatry and leukemia\, and her main scientific interests were benefit-risk assessment\, network meta-analyses\, multiple test proce dures\, simulation models of time-to-event data and survival analysis in p resence of intercurrent events. The development and the promotion of quant itative methods for drug benefit-risk assessments is one of the major topi cs she considers during her PhD\, with the final goal of enhancing decisio n-making throughout the drug life-cycle. \;
\nGraduated in 2011\, Sté\;phanie Cadour works as a biostatisti cian at Servier (France) since then. She was initially responsible for the statistical aspects of phase II and III clinical studies conducted in the therapeutic areas of neuropsychiatry and diabetes. She is now working on early phase studies in the field of oncology. In parallel of these activit ies\, Stephanie developed skills on meta-analyses as well as on quantitati ve approaches for benefit-risk assessment on which she has been working on since 2011.
\n