179 related articles for article (PubMed ID: 37158643)
1. Single-arm trials for US Food and Drug Administration cancer drug approvals: Although there are some challenges in using single-arm studies for accelerated drug approvals, it can make a difference in getting drugs previously approved for other uses to patients.: Although there are some challenges in using single-arm studies for accelerated drug approvals, it can make a difference in getting drugs previously approved for other uses to patients.
Nierengarten MB
Cancer; 2023 Jun; 129(11):1626. PubMed ID: 37158643
[No Abstract] [Full Text] [Related]
2. 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]
3. Review of novel and supplemental approvals of the targeted cancer drugs by the Food and Drug Administration in 2021.
Kandemir EA
J Oncol Pharm Pract; 2023 Jan; 29(1):191-207. PubMed ID: 35793068
[TBL] [Abstract][Full Text] [Related]
4. Comparison of FDA accelerated vs regular pathway approvals for lung cancer treatments between 2006 and 2018.
Ribeiro TB; Buss L; Wayant C; Nobre MRC
PLoS One; 2020; 15(7):e0236345. PubMed ID: 32706800
[TBL] [Abstract][Full Text] [Related]
5. Efficacy evaluation of anticancer agents in single-arm clinical trials: analysis of review reports from Pharmaceuticals and Medical Devices Agency.
Hatogai K; Kato Y; Hirase C
Acta Oncol; 2021 Feb; 60(2):143-148. PubMed ID: 33460336
[TBL] [Abstract][Full Text] [Related]
6. 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]
7. 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]
8. 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]
9. Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.
Shea MB; Roberts SA; Walrath JC; Allen JD; Sigal EV
Clin Cancer Res; 2013 Jul; 19(14):3722-31. PubMed ID: 23665737
[TBL] [Abstract][Full Text] [Related]
10. An empirical analysis of overall survival in drug approvals by the US FDA (2006-2023).
Elbaz J; Haslam A; Prasad V
Cancer Med; 2024 Apr; 13(8):e7190. PubMed ID: 38659418
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. 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]
13. Fragility of randomized trials supporting cancer drug approvals stratified by approval pathway and review designations.
Wilson BE; Desnoyers A; Nadler MB; Tibau A; Amir E
Cancer Med; 2021 Aug; 10(16):5405-5414. PubMed ID: 34323019
[TBL] [Abstract][Full Text] [Related]
14. New Indications and Approvals for Anticancer Drugs.
Aschenbrenner DS
Am J Nurs; 2021 Dec; 121(12):16-17. PubMed ID: 34792500
[TBL] [Abstract][Full Text] [Related]
15. Rare cancer trial design: lessons from FDA approvals.
Gaddipati H; Liu K; Pariser A; Pazdur R
Clin Cancer Res; 2012 Oct; 18(19):5172-8. PubMed ID: 22718862
[TBL] [Abstract][Full Text] [Related]
16. Characteristics and outcomes of new molecular oncology drug approvals, in combination or monotherapy.
Ranganathan S; Haslam A; Tuia J; Prasad V
J Cancer Policy; 2024 Mar; 39():100462. PubMed ID: 38061492
[TBL] [Abstract][Full Text] [Related]
17. Innovating by developing new uses of already-approved drugs: trends in the marketing approval of supplemental indications.
DiMasi JA
Clin Ther; 2013 Jun; 35(6):808-18. PubMed ID: 23726388
[TBL] [Abstract][Full Text] [Related]
18. The response rate of alternative treatments for drugs approved on the basis of response rate.
Haslam A; Gill J; Prasad V
Int J Cancer; 2021 Feb; 148(3):713-722. PubMed ID: 32700797
[TBL] [Abstract][Full Text] [Related]
19. Oncology's trial and error: Analysis of the FDA withdrawn accelerated approvals.
Preziosi AJ; Priefer R
Life Sci; 2024 Jun; 346():122615. PubMed ID: 38582392
[TBL] [Abstract][Full Text] [Related]
20. Regulatory characteristics and pivotal study design of US Food and Drug Administration approval of drugs for major vs. minor cancer.
Yamashita K; Kaneko M; Narukawa M
Eur J Clin Pharmacol; 2019 Sep; 75(9):1193-1200. PubMed ID: 31129731
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]
