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  • Clinical Value of Molecular Targets and FDA-Approved Genome-Targeted Cancer Therapies

    Abstract Full Text
    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.

  • Analysis of Launch and Postapproval Cancer Drug Pricing, Clinical Benefit, and Policy Implications in the US and Europe

    Abstract Full Text
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    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.

  • Association Between Data Sources and US Food and Drug Administration Drug Safety Communications

    Abstract Full Text
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    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.

  • Assessment of Frequency and Reporting of Changes in Cancer Trial Design After Initiation of Patient Accrual

    Abstract Full Text
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    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.

  • Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials

    Abstract Full Text
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    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.

  • Oncologic Drugs Advisory Committee Recommendations and Approval of Cancer Drugs by the US Food and Drug Administration

    Abstract Full Text
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    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.