253 related articles for article (PubMed ID: 26913938)
1. Response Rate as an Approval End Point in Oncology: Back to the Future.
Blumenthal GM; Pazdur R
JAMA Oncol; 2016 Jun; 2(6):780-1. PubMed ID: 26913938
[No Abstract] [Full Text] [Related]
2. Evaluation and Regulation of Oncology Drug Approval: Finding the Right Balance.
Lyman GH
JAMA Oncol; 2016 Jun; 2(6):728-9. PubMed ID: 26939751
[No Abstract] [Full Text] [Related]
3. Oncology update.
Smart M
Oncol Nurs Forum; 2011 Jul; 38(4):485-6. PubMed ID: 21708539
[No Abstract] [Full Text] [Related]
4. Accelerated approval and oncology drug development timelines.
Lanthier ML; Sridhara R; Johnson JR; Farrell A; Keegan P; Justice R; Pazdur R
J Clin Oncol; 2010 May; 28(14):e226-7; author reply e228. PubMed ID: 20194846
[No Abstract] [Full Text] [Related]
5. Drug Development, Trial Design, and Endpoints in Oncology: Adapting to Rapidly Changing Science.
Blumenthal GM; Goldberg KB; Pazdur R
Clin Pharmacol Ther; 2017 May; 101(5):572-574. PubMed ID: 28074476
[TBL] [Abstract][Full Text] [Related]
6. An Appraisal of Clinically Meaningful Outcomes Guidelines for Oncology Clinical Trials.
Kumar H; Fojo T; Mailankody S
JAMA Oncol; 2016 Sep; 2(9):1238-40. PubMed ID: 27281466
[No Abstract] [Full Text] [Related]
7. Regulatory watch: Why do oncology drugs fail to gain US regulatory approval?
Khozin S; Liu K; Jarow JP; Pazdur R
Nat Rev Drug Discov; 2015 Jul; 14(7):450-1. PubMed ID: 26000722
[No Abstract] [Full Text] [Related]
8. End points and United States Food and Drug Administration approval of oncology drugs.
Johnson JR; Williams G; Pazdur R
J Clin Oncol; 2003 Apr; 21(7):1404-11. PubMed ID: 12663734
[TBL] [Abstract][Full Text] [Related]
9. This Time I Mean It!
Tempero M
J Natl Compr Canc Netw; 2020 Jan; 18(1):1. PubMed ID: 31910382
[No Abstract] [Full Text] [Related]
10. Cancer Drugs Approved on the Basis of a Surrogate End Point and Subsequent Overall Survival: An Analysis of 5 Years of US Food and Drug Administration Approvals.
Kim C; Prasad V
JAMA Intern Med; 2015 Dec; 175(12):1992-4. PubMed ID: 26502403
[No Abstract] [Full Text] [Related]
11. Better prioritization may speed approval of adjuvant therapies in breast cancer.
Tuma RS
J Natl Cancer Inst; 2008 Jun; 100(12):842-4. PubMed ID: 18544735
[No Abstract] [Full Text] [Related]
12. Assessing tumor-related signs and symptoms to support cancer drug approval.
Williams G; Pazdur R; Temple R
J Biopharm Stat; 2004 Feb; 14(1):5-21. PubMed ID: 15027497
[TBL] [Abstract][Full Text] [Related]
13. 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]
14. FDA Oncology Center of Excellence Review Processes and Tools.
Gao JJ; Kluetz PG; Pazdur R
Clin Pharmacol Ther; 2020 Sep; 108(3):428-429. PubMed ID: 32654129
[No Abstract] [Full Text] [Related]
15. Approvals in 2018: a histology-agnostic new molecular entity, novel end points and real-time review.
Blumenthal GM; Pazdur R
Nat Rev Clin Oncol; 2019 Mar; 16(3):139-141. PubMed ID: 30670830
[No Abstract] [Full Text] [Related]
16. Median Survival or Mean Survival: Which Measure Is the Most Appropriate for Patients, Physicians, and Policymakers?
Ben-Aharon O; Magnezi R; Leshno M; Goldstein DA
Oncologist; 2019 Nov; 24(11):1469-1478. PubMed ID: 31320502
[TBL] [Abstract][Full Text] [Related]
17. Real-world evidence and regulatory drug approval.
Raphael MJ; Gyawali B; Booth CM
Nat Rev Clin Oncol; 2020 May; 17(5):271-272. PubMed ID: 32112057
[No Abstract] [Full Text] [Related]
18. Oncology approvals in 2020: a year of firsts in the midst of a pandemic.
Amiri-Kordestani L; Pazdur R
Nat Rev Clin Oncol; 2021 Mar; 18(3):129-130. PubMed ID: 33514911
[TBL] [Abstract][Full Text] [Related]
19. Cancer research in the United States: A critical review of current status and proposal for alternative models.
Kantarjian HM; Prat F; Steensma DP; Kurzrock R; Stewart DJ; Sekeres MA; Leveque J
Cancer; 2018 Jul; 124(14):2881-2889. PubMed ID: 29757456
[No Abstract] [Full Text] [Related]
20. Oncology 2020: a drug development and approval paradigm.
Dhingra K
Ann Oncol; 2015 Nov; 26(11):2347-50. PubMed ID: 26374285
[No Abstract] [Full Text] [Related]
[Next] [New Search]
