463 related articles for article (PubMed ID: 31046071)
1. Analysis of Control Arm Quality in Randomized Clinical Trials Leading to Anticancer Drug Approval by the US Food and Drug Administration.
Hilal T; Sonbol MB; Prasad V
JAMA Oncol; 2019 Jun; 5(6):887-892. PubMed ID: 31046071
[TBL] [Abstract][Full Text] [Related]
2. Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.
Hilal T; Gonzalez-Velez M; Prasad V
JAMA Intern Med; 2020 Aug; 180(8):1108-1115. PubMed ID: 32539071
[TBL] [Abstract][Full Text] [Related]
3. Control Groups in RCTs Supporting Approval of Drugs for Systemic Rheumatic Diseases, 2012-2022.
Liu Y; Xie Y; Qin Y; Xie Q; Chen X
JAMA Netw Open; 2023 Nov; 6(11):e2344767. PubMed ID: 37991756
[TBL] [Abstract][Full Text] [Related]
4. U.S. Food and Drug Administration anticancer drug approval trends from 2016 to 2018 for lung, colorectal, breast, and prostate cancer.
Ribeiro TB; Ribeiro A; Rodrigues LO; Harada G; Nobre MRC
Int J Technol Assess Health Care; 2020; 36(1):20-28. PubMed ID: 31775939
[TBL] [Abstract][Full Text] [Related]
5. Cost per Event Averted in Cancer Trials in the Adjuvant Setting From 2018 to 2022.
Mousavi I; Olivier T; Prasad V
JAMA Netw Open; 2022 Jun; 5(6):e2216058. PubMed ID: 35687338
[TBL] [Abstract][Full Text] [Related]
6. Single-arm clinical trials that supported FDA accelerated approvals have modest effect sizes and were at high risk of bias.
Ribeiro TB; Colunga-Lozano LE; Araujo APV; Bennett CL; Hozo I; Djulbegovic B
J Clin Epidemiol; 2022 Aug; 148():193-195. PubMed ID: 35093531
[TBL] [Abstract][Full Text] [Related]
7. Cancer Drug Approvals That Displaced Existing Standard-of-Care Therapies, 2016-2021.
Benjamin DJ; Xu A; Lythgoe MP; Prasad V
JAMA Netw Open; 2022 Mar; 5(3):e222265. PubMed ID: 35289858
[TBL] [Abstract][Full Text] [Related]
8. Feasibility of Randomized Controlled Trials for Cancer Drugs Approved by the Food and Drug Administration Based on Single-Arm Studies.
Rittberg R; Czaykowski P; Niraula S
JNCI Cancer Spectr; 2021 Aug; 5(4):. PubMed ID: 34409254
[TBL] [Abstract][Full Text] [Related]
9. Analysis of Supportive Evidence for US Food and Drug Administration Approvals of Novel Drugs in 2020.
Mitra-Majumdar M; Gunter SJ; Kesselheim AS; Brown BL; Joyce KW; Ross M; Pham C; Avorn J; Darrow JJ
JAMA Netw Open; 2022 May; 5(5):e2212454. PubMed ID: 35579897
[TBL] [Abstract][Full Text] [Related]
10. Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.
Ladanie A; Schmitt AM; Speich B; Naudet F; Agarwal A; Pereira TV; Sclafani F; Herbrand AK; Briel M; Martin-Liberal J; Schmid T; Ewald H; Ioannidis JPA; Bucher HC; Kasenda B; Hemkens LG
JAMA Netw Open; 2020 Nov; 3(11):e2024406. PubMed ID: 33170262
[TBL] [Abstract][Full Text] [Related]
11. Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019.
Dhodapkar M; Zhang AD; Puthumana J; Downing NS; Shah ND; Ross JS
JAMA Netw Open; 2021 Jun; 4(6):e2113224. PubMed ID: 34110392
[TBL] [Abstract][Full Text] [Related]
12. Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.
Gyawali B; Hey SP; Kesselheim AS
JAMA Intern Med; 2019 Jul; 179(7):906-913. PubMed ID: 31135808
[TBL] [Abstract][Full Text] [Related]
13. Timing and Characteristics of Cumulative Evidence Available on Novel Therapeutic Agents Receiving Food and Drug Administration Accelerated Approval.
Naci H; Wouters OJ; Gupta R; Ioannidis JPA
Milbank Q; 2017 Jun; 95(2):261-290. PubMed ID: 28589600
[TBL] [Abstract][Full Text] [Related]
14. An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate.
Chen EY; Raghunathan V; Prasad V
JAMA Intern Med; 2019 Jul; 179(7):915-921. PubMed ID: 31135822
[TBL] [Abstract][Full Text] [Related]
15. An estimate of rate of deviation from NCCN guideline recommendations for central nervous system imaging in trials forming basis for drug approval in first line advanced non-small cell lung cancer (NSCLC).
Sharp J; Prasad V
BMC Cancer; 2022 Jan; 22(1):70. PubMed ID: 35034621
[TBL] [Abstract][Full Text] [Related]
16. Quality of biomarker defined subgroups in FDA approvals of PD-1/PD-L1 inhibitors 2014 to 2020.
Kim MS; Xu A; Haslam A; Prasad V
Int J Cancer; 2022 Jun; 150(11):1905-1910. PubMed ID: 35182072
[TBL] [Abstract][Full Text] [Related]
17. Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.
Salcher-Konrad M; Naci H; Davis C
Milbank Q; 2020 Dec; 98(4):1219-1256. PubMed ID: 33021339
[TBL] [Abstract][Full Text] [Related]
18. Anticancer Drugs Approved by the US Food and Drug Administration From 2009 to 2020 According to Their Mechanism of Action.
Olivier T; Haslam A; Prasad V
JAMA Netw Open; 2021 Dec; 4(12):e2138793. PubMed ID: 34905002
[TBL] [Abstract][Full Text] [Related]
19. Patient Participation in Clinical Trials of Oncology Drugs and Biologics Preceding Approval by the US Food and Drug Administration.
Hutchinson N; Carlisle B; Doussau A; Bosan R; Gumnit E; MacPherson A; Fergusson DA; Kimmelman J
JAMA Netw Open; 2021 May; 4(5):e2110456. PubMed ID: 34003270
[TBL] [Abstract][Full Text] [Related]
20. Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999-2014.
Hatswell AJ; Baio G; Berlin JA; Irs A; Freemantle N
BMJ Open; 2016 Jun; 6(6):e011666. PubMed ID: 27363818
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
