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
来源：
JOURNAL OF CLINICAL ONCOLOGY | 2024年 / 42卷 / 32期
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
  • [1] Communication of Survival Data in US Food and Drug Administration-Approved Labeling of Cancer Drugs
    Naci, Huseyin
    Guan, Xiaodong
    Woloshin, Steven
    Xu, Ziyue
    Wagner, Anita K.
    JAMA INTERNAL MEDICINE, 2021, 181 (11) : 1521 - 1522
  • [2] Integrating New Effectiveness Data Into US Food and Drug Administration-Approved Drug Labeling
    Gyawali, Bishal
    Darrow, Jonathan J.
    Kesselheim, Aaron S.
    JAMA INTERNAL MEDICINE, 2021, 181 (07) : 897 - 898
  • [3] Mechanisms of Action of the US Food and Drug Administration-Approved Antisense Oligonucleotide Drugs
    Sang, Angela
    Zhuo, Selena
    Bochanis, Adara
    Manautou, Jose E.
    Bahal, Raman
    Zhong, Xiao-bo
    Rasmussen, Theodore P.
    BIODRUGS, 2024, 38 (04) : 511 - 526
  • [4] Missing Companion Diagnostic for US Food and Drug Administration-Approved Hematological and Oncological Drugs
    Jorgensen, Jan Trost
    JCO PRECISION ONCOLOGY, 2022, 6
  • [5] Report of the Council on Scientific Affairs: Unlabeled indications of Food and Drug Administration-approved drugs
    Cranston, JW
    Williams, MA
    Nielsen, NH
    Bezman, RJ
    DRUG INFORMATION JOURNAL, 1998, 32 (04): : 1049 - 1061
  • [6] Report of the Council on Scientific Affairs: Unlabeled Indications of Food and Drug Administration-Approved Drugs
    Joseph W. Cranston
    Michael A. Williams
    Nancy H. Nielsen
    Rebecca J. Bezman
    Drug information journal : DIJ / Drug Information Association, 1998, 32 (4): : 1049 - 1061
  • [7] Audit of Data Sharing by Pharmaceutical Companies for Anticancer Medicines Approved by the US Food and Drug Administration
    Modi, Natansh D.
    Abuhelwa, Ahmad Y.
    McKinnon, Ross A.
    Boddy, Alan, V
    Haseloff, Mark
    Wiese, Michael D.
    Hoffmann, Tammy C.
    Perakslis, Eric D.
    Rowland, Andrew
    Sorich, Michael J.
    Hopkins, Ashley M.
    JAMA ONCOLOGY, 2022, 8 (09) : 1310 - 1316
  • [8] Audit of data sharing by pharmaceutical companies for anticancer medicines approved by the US food and drug administration
    Modi, Natansh D.
    Hopkins, AshleyM.
    Sorich, Michael J.
    ASIA-PACIFIC JOURNAL OF CLINICAL ONCOLOGY, 2022, 18 : 171 - 172
  • [9] Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration
    Tibau, Ariadna
    Molto, Consolacion
    Ocana, Alberto
    Templeton, Arnoud J.
    Del Carpio, Luis P.
    Del Paggio, Joseph C.
    Barnadas, Agusti
    Booth, Christopher M.
    Amir, Eitan
    JNCI-JOURNAL OF THE NATIONAL CANCER INSTITUTE, 2018, 110 (05): : 486 - 492
  • [10] Estimated costs of pivotal trials for US Food and Drug Administration-approved cancer drugs, 2015-2017
    Hsiue, Emily Han-Chung
    Moore, Thomas J.
    Alexander, G. Caleb
    CLINICAL TRIALS, 2020, 17 (02) : 119 - 125
12345