189 related articles for article (PubMed ID: 25948678)
1. Observations on Three Endpoint Properties and Their Relationship to Regulatory Outcomes of European Oncology Marketing Applications.
Liberti L; Stolk P; McAuslane JN; Schellens J; Breckenridge AM; Leufkens H
Oncologist; 2015 Jun; 20(6):683-91. PubMed ID: 25948678
[TBL] [Abstract][Full Text] [Related]
2. Selection of Endpoints in Clinical Trials: Trends in European Marketing Authorization Practice in Oncological Indications.
Kordecka A; Walkiewicz-Żarek E; Łapa J; Sadowska E; Kordecki M
Value Health; 2019 Aug; 22(8):884-890. PubMed ID: 31426929
[TBL] [Abstract][Full Text] [Related]
3. The use of validated and nonvalidated surrogate endpoints in two European Medicines Agency expedited approval pathways: A cross-sectional study of products authorised 2011-2018.
Schuster Bruce C; Brhlikova P; Heath J; McGettigan P
PLoS Med; 2019 Sep; 16(9):e1002873. PubMed ID: 31504034
[TBL] [Abstract][Full Text] [Related]
4. [Cancer: Is it really so different? Particularities of oncologic drugs from the perspective of the pharmaceutical regulatory agency].
Enzmann H; Broich K
Z Evid Fortbild Qual Gesundhwes; 2013; 107(2):120-8. PubMed ID: 23663906
[TBL] [Abstract][Full Text] [Related]
5. Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019.
Lythgoe MP; Desai A; Gyawali B; Savage P; Krell J; Warner JL; Khaki AR
JAMA Netw Open; 2022 Jun; 5(6):e2216183. PubMed ID: 35687337
[TBL] [Abstract][Full Text] [Related]
6. Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials.
Chen EY; Joshi SK; Tran A; Prasad V
JAMA Intern Med; 2019 May; 179(5):642-647. PubMed ID: 30933235
[TBL] [Abstract][Full Text] [Related]
7. Ovarian cancer clinical trial endpoints: Society of Gynecologic Oncology white paper.
Herzog TJ; Armstrong DK; Brady MF; Coleman RL; Einstein MH; Monk BJ; Mannel RS; Thigpen JT; Umpierre SA; Villella JA; Alvarez RD
Gynecol Oncol; 2014 Jan; 132(1):8-17. PubMed ID: 24239753
[TBL] [Abstract][Full Text] [Related]
8. Surrogate endpoints for overall survival in digestive oncology trials: which candidates? A questionnaires survey among clinicians and methodologists.
Methy N; Bedenne L; Bonnetain F
BMC Cancer; 2010 Jun; 10():277. PubMed ID: 20537166
[TBL] [Abstract][Full Text] [Related]
9. Review of oncology and hematology drug product approvals at the US Food and Drug Administration between July 2005 and December 2007.
Sridhara R; Johnson JR; Justice R; Keegan P; Chakravarty A; Pazdur R
J Natl Cancer Inst; 2010 Feb; 102(4):230-43. PubMed ID: 20118413
[TBL] [Abstract][Full Text] [Related]
10. Are Surrogate Endpoints Unbiased Metrics in Clinical Benefit Scores of the ASCO Value Framework?
Cheng S; Cheung MC; Jiang DM; McDonald E; Arciero VS; Ezeife DA; Rahmadian A; Chambers A; Sabarre KA; Parmar A; Chan KKW
J Natl Compr Canc Netw; 2019 Dec; 17(12):1489-1496. PubMed ID: 31805528
[TBL] [Abstract][Full Text] [Related]
11. 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]
12. Factors associated with success of market authorisation applications for pharmaceutical drugs submitted to the European Medicines Agency.
Regnstrom J; Koenig F; Aronsson B; Reimer T; Svendsen K; Tsigkos S; Flamion B; Eichler HG; Vamvakas S
Eur J Clin Pharmacol; 2010 Jan; 66(1):39-48. PubMed ID: 19936724
[TBL] [Abstract][Full Text] [Related]
13. Cancer drugs for solid tumors approved by the EMA since 2014: an overview of pivotal clinical trials.
Lasala R; Logreco A; Romagnoli A; Santoleri F; Musicco F; Costantini A
Eur J Clin Pharmacol; 2020 Jun; 76(6):843-850. PubMed ID: 32125472
[TBL] [Abstract][Full Text] [Related]
14. Meaningful endpoints for therapies approved for hematologic malignancies.
Smith BD; DeZern AE; Bastian AW; Durie BGM
Cancer; 2017 May; 123(10):1689-1694. PubMed ID: 28222220
[TBL] [Abstract][Full Text] [Related]
15. Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021.
Vokinger KN; Kesselheim AS; Glaus CEG; Hwang TJ
JAMA Health Forum; 2022 Aug; 3(8):e222685. PubMed ID: 36200635
[TBL] [Abstract][Full Text] [Related]
16. Availability of evidence of benefits on overall survival and quality of life of cancer drugs approved by European Medicines Agency: retrospective cohort study of drug approvals 2009-13.
Davis C; Naci H; Gurpinar E; Poplavska E; Pinto A; Aggarwal A
BMJ; 2017 Oct; 359():j4530. PubMed ID: 28978555
[No Abstract] [Full Text] [Related]
17. Assessing the benefit of cancer drugs approved by the European Medicines Agency using the European Society for Medical Oncology Magnitude of Clinical Benefit Scale over time.
Thomson S; Witzke N; Gyawali B; Delos Santos S; Udayakumar S; Cardone C; Cheung MC; Chan KKW
Eur J Cancer; 2021 Jun; 150():203-210. PubMed ID: 33932727
[TBL] [Abstract][Full Text] [Related]
18. Comparison between European Medicines Agency and US Food and Drug Administration in Granting Accelerated Marketing Authorizations for Covid-19 Medicines and their Utilized Regulations.
Ghadanian M; Schafheutle E
Ther Innov Regul Sci; 2024 Jan; 58(1):79-113. PubMed ID: 37861859
[TBL] [Abstract][Full Text] [Related]
19. Trends in endpoint use in pivotal trials and efficacy for US Food and Drug Administration-approved solid tumor therapies, 1995-2021.
Alabaku O; Laffey TN; Suh K; Li M
J Manag Care Spec Pharm; 2022 Nov; 28(11):1219-1223. PubMed ID: 36282934
[No Abstract] [Full Text] [Related]
20. A detailed analysis of expedited regulatory review time of marketing authorization applications for new anticancer drugs in the US and EU.
da Costa Gonçalves F; Demirci E; Zwiers A
Clin Transl Sci; 2022 Aug; 15(8):1959-1967. PubMed ID: 35561071
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]