Clinical Study Report and Individual Participant Data Transparency for US Food and Drug Administration-Approved Anticancer Drugs: A Call for Systematic Data Availability

被引:0
|
作者
Modi, Natansh D. [1 ]
Swain, Sandra M. [2 ]
Buyse, Marc [3 ,4 ]
Kuderer, Nicole M. [5 ]
Rowland, Andrew [1 ]
Rockhold, Frank W. [6 ]
Sorich, Michael J. [1 ]
Hopkins, Ashley M. [1 ]
机构
[1] Flinders Univ S Australia, Coll Med & Publ Hlth, Adelaide, Australia
[2] MedStar Hlth, Georgetown Lombardi Comprehens Canc Ctr, Washington, DC USA
[3] Hasselt Univ, Int Drug Dev Inst IDDI, Hasselt, Belgium
[4] Hasselt Univ, Interuniv Inst Biostat & Stat Bioinformat, Hasselt, Belgium
[5] Adv Canc Res Grp, Kirkland, WA USA
[6] Duke Univ, Dept Biostat & Bioinformat, Durham, NC USA
基金
英国医学研究理事会; 澳大利亚国家健康与医学研究理事会;
关键词
D O I
10.1200/JCO.24.00539
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
引用
收藏
页数:6
相关论文
共 50 条
  • [31] Safety profile of drugs for advanced melanoma: A report based on 2008-2018 US Food and Drug Administration Data
    Casarotto, Emilie
    Noize, Pernelle
    Letinier, Louis
    Salvo, Francesco
    Pham-Ledard, Anne
    Molimard, Mathieu
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 2021, 87 (07) : 2988 - 2995
  • [32] Transparency of Regulatory Data across the European Medicines Agency, Health Canada, and US Food and Drug Administration
    Egilman, Alexander C.
    Kapczynski, Amy
    McCarthy, Margaret E.
    Luxkaranayagam, Anita T.
    Morten, Christopher J.
    Herder, Matthew
    Wallach, Joshua D.
    Ross, Joseph S.
    JOURNAL OF LAW MEDICINE & ETHICS, 2021, 49 (03): : 456 - 485
  • [33] Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials
    Tibau, Ariadna
    Molto, Consolacion
    Borrell, Maria
    Del Paggio, Joseph C.
    Barnadas, Agusti
    Booth, Christopher M.
    Amir, Eitan
    JAMA ONCOLOGY, 2018, 4 (11) : 1610 - 1611
  • [34] Risk of Enzyme- and Transporter-mediated Drug Interactions With Drugs Approved by the US Food and Drug Administration in 2022: A Detailed Analysis of In Vitro and Clinical Data Available in New Drug Application Reviews
    Yu, Jingjing
    Wang, Yan
    Ragueneau-Majlessi, Isabelle
    CLINICAL THERAPEUTICS, 2024, 46 (06) : 499 - 508
  • [35] Special Section on Pharmacokinetics and ADME of Biological Therapeutics-Minireview Absorption, Distribution, Metabolism, and Excretion of US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
    Migliorati, Julia M.
    Liu, Sunna
    Liu, Anna
    Gogate, Anagha
    Nair, Sreenidhi
    Bahal, Raman
    Rasmussen, Theodore P.
    Manautou, Jose E.
    Zhong, Xiao-bo
    DRUG METABOLISM AND DISPOSITION, 2022, 50 (06) : 888 - 897
  • [36] Response to acute monotherapy for major depressive disorder in randomized, placebo controlled trials submitted to the US Food and Drug Administration: individual participant data analysis
    Stone, Marc B.
    Yaseen, Zimri S.
    Miller, Brian J.
    Richardville, Kyle
    Kalaria, Shamir N.
    Kirsch, Irving
    BMJ-BRITISH MEDICAL JOURNAL, 2022, 378
  • [37] DETAILED EVALUATION OF PK-BASED DRUG-DRUG INTERACTION DATA CONTAINED IN NEW DRUG AND BIOLOGIC LICENSE APPLICATIONS OF DRUGS APPROVED BY THE US FOOD AND DRUG ADMINISTRATION IN 2015
    Yu, J.
    Zhou, Z.
    Owens, K.
    Ritchie, T.
    Ragueneau-Majlessi, I.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2017, 101 (S1) : S13 - S13
  • [38] What can be learned from the nda and bla reviews of newly approved drugs? A systematic review of drug interaction data for drugs approved by the US FDA IN 2014
    Yu, Jingjing
    Ritchie, Tasha K.
    Zhou, Zhu
    Ragueneau-Majlessi, Isabelle
    DRUG METABOLISM REVIEWS, 2016, 48 : 81 - 81
  • [40] Clinical benefit and cost of breakthrough cancer drugs approved by the US Food and Drug Administration (vol 126, pg 4390, 2020)
    Molto, Consolacion
    Hwang, Thomas J.
    Borrell, Maria
    Andres, Marta
    Gich, Ignasi
    Barnadas, Agusti
    Amir, Eitan
    Kesselheim, Aaron S.
    Tibau, Ariadna
    CANCER, 2021, 127 (17) : 3266 - 3266