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JAMA Oncology
Original Investigation
April 4, 2024
AriadnaÌýTibau,ÌýMD, PhD; Thomas J.ÌýHwang,ÌýMD; ConsolacionÌýMolto,ÌýMD, PhD; JerryÌýAvorn,ÌýMD; Aaron S.ÌýKesselheim,ÌýMD, JD, MPH
JAMA Oncol. 2024; 10(5):634-641. 10.1001/jamaoncol.2024.0194
This cohort study assesses the validity of molecular targets and therapeutic benefits of US Food and Drug Administration (FDA)–approved genome-targeted cancer drugs based on the outcomes of their corresponding pivotal clinical trials.
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JAMA Oncology
Original Investigation
July 1, 2021
Kerstin N.ÌýVokinger,ÌýMD, JD, PhD, LLM; Thomas J.ÌýHwang,ÌýAB; PaolaÌýDaniore,ÌýMSc; ChangWon C.ÌýLee,ÌýAB; AriadnaÌýTibau,ÌýMD; ThomasÌýGrischott,ÌýMD, MSc; Thomas J.ÌýRosemann,ÌýMD, PhD; Aaron S.ÌýKesselheim,ÌýMD, JD, MPH
free access
online only
JAMA Oncol. 2021; 7(9):e212026. 10.1001/jamaoncol.2021.2026
This economic evaluation examines the prices of cancer drugs on initial marketing and postlaunch prices and any association with clinical benefit.
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JAMA Internal Medicine
Research Letter
September 3, 2019
NoamÌýTau,ÌýMD; TzippyÌýShochat,ÌýMSc; AnatÌýGafter-Gvili,ÌýMD; AriadnaÌýTibau,ÌýMD, PhD; EitanÌýAmir,ÌýMD, PhD; DanielÌýShepshelovich,ÌýMD
free access
JAMA Intern Med. 2019; 179(11):1590-1592. 10.1001/jamainternmed.2019.3066
This study describes sources of initial safety signals that that preceded US Food and Drug Administration (FDA) drug safety communications and examines their associations with drug characteristics and subsequent label changes.
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JAMA Oncology
Research Letter
January 1, 2019
DanielÌýShepshelovich,ÌýMD; AriadnaÌýTibau,ÌýMD, PhD; ConsolaciónÌýMolto,ÌýMD; HadarÌýGoldvaser,ÌýMD; AlbertoÌýOcana,ÌýMD, PhD; BostjanÌýÅ eruga,ÌýMD, PhD; EitanÌýAmir,ÌýMD, PhD
free access
JAMA Oncol. 2019; 5(1):107-109. 10.1001/jamaoncol.2018.5877
This study matches entries in ClinicalTrials.gov for cancer drug trials at initiation of the trial with later entries and with journal reports of the trials to assess modifications in trial design, external factors associated with such modifications, and transparency in reporting them.
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JAMA Oncology
Research Letter
November 1, 2018
AriadnaÌýTibau,ÌýMD, PhD; ConsolaciónÌýMolto,ÌýMD; MariaÌýBorrell,ÌýMD; Joseph C.ÌýDel Paggio,ÌýMD; AgustÃÌýBarnadas,ÌýMD, PhD; Christopher M.ÌýBooth,ÌýMD; EitanÌýAmir,ÌýMD, PhD
free access
JAMA Oncol. 2018; 4(11):1610-1611. 10.1001/jamaoncol.2018.4300
This study uses the European Society of Medical Oncology Magnitude of Clinical Benefit Scale to evaluate the clinical benefit of anticancer drugs that gained approval by the US Food and Drug Administration based on single-arm rather than randomized clinical trials.
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JAMA Oncology
Original Investigation
June 1, 2016
AriadnaÌýTibau,ÌýMD; AlbertoÌýOcana,ÌýMD, PhD; GeòrgiaÌýAnguera,ÌýMD; BostjanÌýSeruga,ÌýMD, PhD; Arnoud J.ÌýTempleton,ÌýMD; AgustÃÌýBarnadas,ÌýMD, PhD; EitanÌýAmir,ÌýMD, PhD
free access
JAMA Oncol. 2016; 2(6):744-750. 10.1001/jamaoncol.2015.6479
This analysis of 82 Oncologic Drugs Advisory Committee (ODAC) meeting transcripts explores the association between ODAC recommendations, ODAC members’ financial conflicts of interest, and approval of new oncologic drugs by the US Food and Drug Administration.