343 related articles for article (PubMed ID: 34371443)
1. Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study.
Boyle JM; Hegarty G; Frampton C; Harvey-Jones E; Dodkins J; Beyer K; George G; Sullivan R; Booth C; Aggarwal A
Eur J Cancer; 2021 Sep; 155():136-144. PubMed ID: 34371443
[TBL] [Abstract][Full Text] [Related]
2. 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]
3. 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]
4. Use of Real-world Data for New Drug Applications and Line Extensions.
Bolislis WR; Fay M; Kühler TC
Clin Ther; 2020 May; 42(5):926-938. PubMed ID: 32340916
[TBL] [Abstract][Full Text] [Related]
5. A Qualitative Study on the Differences Between Trial Populations and the Approved Therapeutic Indications of Antineoplastic Agents by 3 Regulatory Agencies From 2010 to 2018.
Sumi E; Asada R; Lu Y; Ito-Ihara T; Grimes KV
Clin Ther; 2020 Feb; 42(2):305-320.e0. PubMed ID: 32008723
[TBL] [Abstract][Full Text] [Related]
6. Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA.
Mofid S; Bolislis WR; Kühler TC
Clin Ther; 2022 Feb; 44(2):306-322. PubMed ID: 35074209
[TBL] [Abstract][Full Text] [Related]
7. 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]
8. Assessment of Food and Drug Administration- and European Medicines Agency-Approved Systemic Oncology Therapies and Clinically Meaningful Improvements in Quality of Life: A Systematic Review.
Arciero V; Delos Santos S; Koshy L; Rahmadian A; Saluja R; Everest L; Parmar A; Chan KKW
JAMA Netw Open; 2021 Feb; 4(2):e2033004. PubMed ID: 33570573
[TBL] [Abstract][Full Text] [Related]
9. Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines.
Salas-Vega S; Iliopoulos O; Mossialos E
JAMA Oncol; 2017 Mar; 3(3):382-390. PubMed ID: 28033447
[TBL] [Abstract][Full Text] [Related]
10. A Review of Patient-Reported Outcomes Labeling for Oncology Drugs Approved by the FDA and the EMA (2012-2016).
Gnanasakthy A; Barrett A; Evans E; D'Alessio D; Romano CD
Value Health; 2019 Feb; 22(2):203-209. PubMed ID: 30711065
[TBL] [Abstract][Full Text] [Related]
11. Comparison of two assessments of real-world data and real-world evidence for regulatory decision-making.
Yuan L; Rahman M; Concato J
Clin Transl Sci; 2024 Jan; 17(1):e13702. PubMed ID: 38093484
[TBL] [Abstract][Full Text] [Related]
12. 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]
13. 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]
14. A systematic review of real-world evidence (RWE) supportive of new drug and biologic license application approvals in rare diseases.
Vaghela S; Tanni KA; Banerjee G; Sikirica V
Orphanet J Rare Dis; 2024 Mar; 19(1):117. PubMed ID: 38475874
[TBL] [Abstract][Full Text] [Related]
15. Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA.
Michaeli DT; Mills M; Michaeli T; Miracolo A; Kanavos P
Invest New Drugs; 2022 Aug; 40(4):798-809. PubMed ID: 35389145
[TBL] [Abstract][Full Text] [Related]
16. To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016.
Kühler TC; Bujar M; McAuslane N; Liberti L
BMJ Open; 2019 Nov; 9(11):e028677. PubMed ID: 31772082
[TBL] [Abstract][Full Text] [Related]
17. Publicly accessible evidence of health-related quality of life benefits associated with cancer drugs approved by the European Medicines Agency between 2009 and 2015.
Grössmann N; Robausch M; Rothschedl E; Wild C; Simon J
Eur J Cancer; 2020 Apr; 129():23-31. PubMed ID: 32120272
[TBL] [Abstract][Full Text] [Related]
18. Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study.
Vokinger KN; Glaus CEG; Kesselheim AS; Serra-Burriel M; Ross JS; Hwang TJ
BMJ; 2023 Jul; 382():e074166. PubMed ID: 37407074
[TBL] [Abstract][Full Text] [Related]
19. Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.
Cherla A; Naci H; Kesselheim AS; Gyawali B; Mossialos E
JAMA Intern Med; 2021 Apr; 181(4):490-498. PubMed ID: 33616607
[TBL] [Abstract][Full Text] [Related]
20. Real-world data for precision cancer medicine-A European perspective.
Christopoulos P; Schlenk R; Kazdal D; Blasi M; Lennerz J; Shah R; Budczies J; Malek N; Fröhling S; Rosenquist R; Schirmacher P; Bozorgmehr F; Kuon J; Reck M; Thomas M; Stenzinger A
Genes Chromosomes Cancer; 2023 Sep; 62(9):557-563. PubMed ID: 36852573
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]