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Grant: Project Grant

McGill University

$531,675.00

Regulatory, Policy and Ethical Implications of Clinical Trial Portfolios

EF 2018-19

Résumé
New drugs are often tested in many clinical trials- often involving several different diseases (we call this collection of clinical trials "trial portfolios"). This vigorous research activity can generate a wealth of information that can be used to inform policy decisions as well as patient protections in trials. At the same time, it can also produce exaggerated estimates of a drug's efficacy- especially when portfolios contain a large number of trials. In this grant, we will examine the extent to which large trial portfolios produce overly optimistic estimates of a drug's efficacy, focusing on cancer drugs. We will also examine the extent to which exaggerated treatment effects lead to erroneous recommendations in clinical practice guidelines. Finally, we will explore how knowledge of trial portfolios can be harnessed to make better decisions about drug approval, and to better protect patients in trials.
Programme
Project Grant
Bénéficiaire
Emplacement
Quebec, Canada
Type de bénéficiaire
Academia
Type
Grant
Source
CIHR Funding Decisions Database

Tel que publié

Id
402661
Name
Kimmelman Jonathan
Region
Québec
Country
Canada
Orgtype
Institution Paid; Research Institution
Instname2
Health Services and Policy Research
Theme2
Health systems / services
Prcname2
Humanities, Social Sciences, Law & Ethics in Health
Projecttitle
Regulatory, Policy and Ethical Implications of Clinical Trial Portfolios
Programtype2
Operating Grants
Orgnameinp2
McGill University
Cihramount2
$531,675
Cihrequipment2
$0
Programname2
Project Grant
Keyworddelim
Bias; Cancer; Clinical Trials; Drug Regulation; Research Ethics
Abstract
New drugs are often tested in many clinical trials- often involving several different diseases (we call this collection of clinical trials "trial portfolios"). This vigorous research activity can generate a wealth of information that can be used to inform policy decisions as well as patient protections in trials. At the same time, it can also produce exaggerated estimates of a drug's efficacy- especially when portfolios contain a large number of trials. In this grant, we will examine the extent to which large trial portfolios produce overly optimistic estimates of a drug's efficacy, focusing on cancer drugs. We will also examine the extent to which exaggerated treatment effects lead to erroneous recommendations in clinical practice guidelines. Finally, we will explore how knowledge of trial portfolios can be harnessed to make better decisions about drug approval, and to better protect patients in trials.
Competitiondate
201903
Approvedterm2
4 yrs 0 mth
Pinamesdelim
Kimmelman, Jonathan
Approvedterm
4 ans 0 mois
Cihrcontribution2
~ $531,675~ $0~