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  • 榴莲视频 Network Open Research Letter Health Policy
    May 1, 2024

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

    Maryam听Mooghali,听MD, MSc; Ayman听Mohammad,听BA; Joshua D.听Wallach,听PhD, MS; Aaron P.听Mitchell,听MD, MPH; Joseph S.听Ross,听MD, MHS; Reshma听Ramachandran,听MD, MPP, MHS
    Abstract Full Text
    open access
    榴莲视频 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鈥檚 Real-Time Oncology Review (RTOR) program in confirming the effectiveness of cancer drugs.

  • JAMA Original Investigation
    April 22, 2024

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

    Joshua D.听Wallach,听PhD, MS; Samuel听Yoon,听BS, BA; Harry听Doernberg,听MM; Laura R.听Glick,听MD; Oriana听Ciani,听PhD; Rod S.听Taylor,听PhD; Maryam听Mooghali,听MD; Reshma听Ramachandran,听MD, MHS, MPP; Joseph S.听Ross,听MD, MHS
    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.

  • JAMA Research Letter
    December 11, 2023

    Pivotal Trial Demographic Representation and Clinical Development Times for Oncology Therapeutics

    Alissa K.听Wong,听BS; Jennifer E.听Miller,听PhD; Maryam听Mooghali,听MD, MSc; Reshma听Ramachandran,听MD, MHS, MPP; Joseph S.听Ross,听MD, MHS; Joshua D.听Wallach,听PhD, MS
    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.

  • 榴莲视频 Network Open Research Letter Health Policy
    August 31, 2023

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

    Alissa K.听Wong,听BS; Maryam听Mooghali,听MD, MSc; Reshma听Ramachandran,听MD, MPP, MHS; Joseph S.听Ross,听MD, MHS; Joshua D.听Wallach,听PhD, MS
    Abstract Full Text
    open access
    榴莲视频 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.

  • JAMA Internal Medicine Research Letter Health Care Policy and Law
    May 15, 2023

    Availability of Unique Device Identifiers for Class I Medical Device Recalls From 2018 to 2022

    Maryam听Mooghali,听MD, MSc; Joseph S.听Ross,听MD, MHS; Kushal T.听Kadakia,听MSc; Sanket S.听Dhruva,听MD, MHS
    Abstract Full Text
    free access
    JAMA Intern Med. 2023; 183(7):735-737. 10.1001/jamainternmed.2023.0727

    This cross-sectional study describes the inclusion of unique device identifier in recall notices for moderate- and high-risk medical devices in the US.