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

页数：6

共 50 条

[41] Gastrointestinal (GI) cancer (CA) drugs approved by the US Food and Drug Administration (FDA): Clinical value and cost considerations.
Jiang, Di Maria
Jang, Raymond Woo-Jun
Chan, Kelvin K.
Liu, Geoffrey
Amir, Eitan
Elimova, Elena
JOURNAL OF CLINICAL ONCOLOGY, 2018, 36 (15)
[42] Clinical benefit of cancer drugs approved by the US food and drug administration based on appropriateness of control arm and its change over time
Molto, C.
Restrepo, A. P.
Templeton, A. J.
Tibau, A.
Mittal, A.
Tamimi, F. T.
Gimenez, D. Malon
Amir, E.
ANNALS OF ONCOLOGY, 2023, 34 : S931 - S931
[43] Magnitude of clinical benefit of cancer drugs approved based on single-arm trials (SAT) by the US Food and Drug Administration (FDA)
Molto Valiente, C.
Borrell, M.
Ocana Fernandez, A.
Templeton, A. J.
del Carpio, L. P.
Del Paggio, J.
Barnadas, A.
Booth, C. M.
Tibau, A.
Amir, E.
ANNALS OF ONCOLOGY, 2018, 29 : 564 - 564
[44] Device Safety Implications of the Clinical Data Leading to US Food and Drug Administration Approval of Soft-Tissue Fillers A Systematic Review
Lohman, Mary E.
Ghobadi, Comeron W.
Xu, Shuai
JAMA FACIAL PLASTIC SURGERY, 2017, 19 (05) : 421 - 429
[45] Participant Recruitment From Low- and Middle-Income Countries for Pivotal Trials of Drugs Approved by the US Food and Drug Administration A Cross-Sectional Analysis
Awan, Fareed A.
Becker, Andrew B.
Wang, Yuetong
Kimmelman, Jonathan
ANNALS OF INTERNAL MEDICINE, 2022, 175 (12) : 1675 - +
[46] What Can Be Learned from Recent New Drug Applications? A Systematic Review of Drug Interaction Data for Drugs Approved by the US FDA in 2015
Yu, Jingjing
Zhou, Zhu
Owens, Katie H.
Ritchie, Tasha K.
Ragueneau-Majlessi, Isabelle
DRUG METABOLISM AND DISPOSITION, 2017, 45 (01) : 86 - 108
[47] Country Contribution to Investigators of Pivotal Clinical Trials and their Primary Publications of New Drugs Approved by the US Food and Drug Administration, 2012-2021
Choi, Yoona
Won, Jung-Hyun
Kim, Heeju
Hong, Yesol
Kim, Yujin
Lee, Howard
CLINICAL PHARMACOLOGY & THERAPEUTICS, 2025, 117 (04) : 1131 - 1141
[48] Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals
Austin Lammers
Ruibin Wang
Jeremy Cetnar
Vinay Prasad
Blood Cancer Journal, 7
[49] Time from US Food and Drug Administration approval to publication of data for cancer drugs: a comparison of first and subsequent approvals
Lammers, Austin
Wang, Ruibin
Cetnar, Jeremy
Prasad, Vinay
BLOOD CANCER JOURNAL, 2017, 7
[50] Current Data on Manganese in Foods and in US Diets from the US Food and Drug Administration's Total Diet Study
Spungen, Judith H.
Pouillot, Regis
Hoffman-Pennesi, Dana
Briguglio, Stephanie
Wirtz, Mark
FASEB JOURNAL, 2016, 30

← 1 2 3 4 5 →