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  • Associations Between Surrogate Markers and Clinical Outcomes for Nononcologic Chronic Disease Treatments

    Abstract Full Text
    online first
    JAMA. 2024; 10.1001/jama.2024.4175

    This study examines the strength of association between surrogate markers used as primary end points in clinical trials to support FDA approval of drugs treating nononcologic chronic diseases and clinical outcomes.

  • Intravascular Microaxial Left Ventricular Assist Device Manufacturer Payments to Cardiologists and Use of Devices

    Abstract Full Text
    JAMA. 2024; 331(17):1499-1501. 10.1001/jama.2024.4682

    This study examines whether payments from a left ventricular assist device manufacturer to cardiologists performing percutaneous coronary intervention were associated with any use of the devices.

  • Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals

    Abstract Full Text
    open access
    ÁñÁ«ÊÓƵ Netw Open. 2024; 7(5):e249233. 10.1001/jamanetworkopen.2024.9233

    This cross-sectional study evaluates the use of the US Food and Drug Administration’s Real-Time Oncology Review (RTOR) program in confirming the effectiveness of cancer drugs.

  • Industry Payments to US Physicians by Specialty and Product Type

    Abstract Full Text
    JAMA. 2024; 331(15):1325-1327. 10.1001/jama.2024.1989

    This study examines the distribution of payments within and across specialties and the medical products associated with the largest total payments.

  • Implications for Public Health Regulation if Chevron Deference Is Overturned

    Abstract Full Text
    JAMA. 2024; 331(17):1443-1444. 10.1001/jama.2024.3654

    This Viewpoint describes implications for medicine and public health if the US Supreme Court decides to overturn or narrow Chevron deference.

  • Hypothetical Assessments of Trial Emulations—Reply

    Abstract Full Text
    JAMA Intern Med. 2024; 184(4):446-447. 10.1001/jamainternmed.2023.7948
  • Measuring Equity in Readmission as a Distinct Assessment of Hospital Performance

    Abstract Full Text
    JAMA. 2024; 331(2):111-123. 10.1001/jama.2023.24874

    This cross-sectional study of US hospitals compared hospital and patient characteristics to evaluate equitable rates of readmission by insurance (dual eligible [Medicare and Medicaid] vs non–dual eligible) and race (Black vs White).

  • Innovation in Development of Dermatologic Drugs Approved by the US Food and Drug Administration Between 2012 and 2022

    Abstract Full Text
    JAMA Dermatol. 2023; 160(2):226-229. 10.1001/jamadermatol.2023.5036

    This cross-sectional study characterizes the frequency and degree of innovation of new dermatologic drugs approved by the US Food and Drug Administration (FDA) from 2012 to 2022.

  • Automation Bias and Assistive AI: Risk of Harm From AI-Driven Clinical Decision Support

    Abstract Full Text
    JAMA. 2023; 330(23):2255-2257. 10.1001/jama.2023.22557
  • Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics

    Abstract Full Text
    JAMA. 2023; 330(24):2392-2394. 10.1001/jama.2023.21958

    This study evaluates whether FDA-approved novel cancer therapeutics supported by pivotal trials with adequate representation of minoritized groups were associated with slower clinical development times than those with inadequate representation.

  • Learning From the Success of the ACTIV Platform

    Abstract Full Text
    free access
    JAMA. 2023; 330(24):2363-2364. 10.1001/jama.2023.24087
  • Aligning US Agency Policies for Cardiovascular Devices Through the Breakthrough Devices Program

    Abstract Full Text
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    JAMA Cardiol. 2023; 8(12):1174-1181. 10.1001/jamacardio.2023.3819

    This study explores the ways new device authorization and coverage are expedited by the US Food and Drug Administration and Centers for Medicare & Medicaid Services, using examples of devices granted Breakthrough designation, and recommends reforms that both agencies should consider.

  • Feasibility of Emulating Clinical Trials Supporting US FDA Supplemental Indication Approvals of Drugs and Biologics

    Abstract Full Text
    JAMA Intern Med. 2023; 183(11):1271-1273. 10.1001/jamainternmed.2023.4073

    This cross-sectional study evaluates the supporting clinical trials for supplemental new drug applications and supplemental biologics license applications from 2017 to 2019.

  • Outcomes in Patients With Poststroke Seizures: A Systematic Review and Meta-Analysis

    Abstract Full Text
    ÁñÁ«ÊÓƵ Neurol. 2023; 80(11):1155-1165. 10.1001/jamaneurol.2023.3240

    This systematic review and meta-analysis investigates the association of mortality, poor functional outcomes, recurrent stroke, and dementia in patients with poststroke seizures compared with patients without poststroke seizures.

  • Unique Device Identifiers for Medical Devices at 10 Years

    Abstract Full Text
    JAMA Intern Med. 2023; 183(10):1045-1046. 10.1001/jamainternmed.2023.3572

    This Viewpoint discusses the next steps to realize the public health promise of using unique device identifiers in health information data and outlines the progress and challenges in implementation over the past 10 years.

  • Financial Conflicts of Interest in Public Comments on Medicare National Coverage Determinations of Medical Devices

    Abstract Full Text
    free access
    JAMA. 2023; 330(11):1094-1096. 10.1001/jama.2023.14414

    This study reviewed public comments for all Medicare National Coverage Determinations between June 2019 and 2022 on select pulmonary and cardiac devices to determine whether financial conflicts of interest were disclosed.

  • Use of Expedited Regulatory Programs and Clinical Development Times for FDA-Approved Novel Therapeutics

    Abstract Full Text
    open access
    ÁñÁ«ÊÓƵ Netw Open. 2023; 6(8):e2331753. 10.1001/jamanetworkopen.2023.31753

    This cross-sectional study evaluates the duration between application to US Food and Drug Administration (FDA) and approval for new drugs and biologics in the US from 2015 to 2022.

  • Medical Product Industry Ties to Patient Advocacy Organizations’ Executive Leadership

    Abstract Full Text
    JAMA Intern Med. 2023; 183(10):1164-1166. 10.1001/jamainternmed.2023.2842

    This cross-sectional study examines the ties between pharmaceutical and medical device industries and the executive leadership of the 50 highest-revenue US-based patient advocacy organizations.

  • Unique Device Identifiers—Missing in Action

    Abstract Full Text
    JAMA Intern Med. 2023; 183(10):1049-1050. 10.1001/jamainternmed.2023.3561
  • Transparency of Results Reporting in Cancer Clinical Trials

    Abstract Full Text
    open access
    ÁñÁ«ÊÓƵ Netw Open. 2023; 6(8):e2328117. 10.1001/jamanetworkopen.2023.28117

    This cross-sectional study investigates rates of results reporting among oncology clinical trials across trial registries, medical journals, and medical conferences.