Literature DB >> 30267037

Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration Based on Single-Arm Trials.

Ariadna Tibau1, Consolación Molto1, Maria Borrell1, Joseph C Del Paggio2, Agustí Barnadas1, Christopher M Booth3,4,5, Eitan Amir2.   

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Year:  2018        PMID： 30267037      PMCID： PMC6584270          DOI： 10.1001/jamaoncol.2018.4300

Source DB:  PubMed          Journal:  JAMA Oncol        ISSN： 2374-2437            Impact factor:   31.777


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  5 in total

1.  Applications for FDA approval to market a dew drug: patent submission and listing requirements and application of 30-month stays on approval of abbreviated new drug applications certifying that a patent claiming a drug is invalid or will not be infringed. Final rule.

Authors: 
Journal:  Fed Regist       Date:  2003-06-18

Review 2.  Role of randomized phase III trials in an era of effective targeted therapies.

Authors:  Manish R Sharma; Richard L Schilsky
Journal:  Nat Rev Clin Oncol       Date:  2011-12-06       Impact factor: 66.675

3.  Magnitude of Clinical Benefit of Cancer Drugs Approved by the US Food and Drug Administration.

Authors:  Ariadna Tibau; Consolación Molto; Alberto Ocana; Arnoud J Templeton; Luis P Del Carpio; Joseph C Del Paggio; Agustí Barnadas; Christopher M Booth; Eitan Amir
Journal:  J Natl Cancer Inst       Date:  2018-05-01       Impact factor: 13.506

4.  New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1).

Authors:  E A Eisenhauer; P Therasse; J Bogaerts; L H Schwartz; D Sargent; R Ford; J Dancey; S Arbuck; S Gwyther; M Mooney; L Rubinstein; L Shankar; L Dodd; R Kaplan; D Lacombe; J Verweij
Journal:  Eur J Cancer       Date:  2009-01       Impact factor: 9.162

5.  ESMO-Magnitude of Clinical Benefit Scale version 1.1.

Authors:  N I Cherny; U Dafni; J Bogaerts; N J Latino; G Pentheroudakis; J-Y Douillard; J Tabernero; C Zielinski; M J Piccart; E G E de Vries
Journal:  Ann Oncol       Date:  2017-10-01       Impact factor: 32.976
  5 in total
  5 in total

1.  Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration.

Authors:  Talal Hilal; Miguel Gonzalez-Velez; Vinay Prasad
Journal:  JAMA Intern Med       Date:  2020-08-01       Impact factor: 21.873

2.  Design characteristics, risk of bias, and reporting of randomised controlled trials supporting approvals of cancer drugs by European Medicines Agency, 2014-16: cross sectional analysis.

Authors:  Huseyin Naci; Courtney Davis; Jelena Savović; Julian P T Higgins; Jonathan A C Sterne; Bishal Gyawali; Xochitl Romo-Sandoval; Nicola Handley; Christopher M Booth
Journal:  BMJ       Date:  2019-09-18

3.  Required efficacy for novel therapies in BCG-unresponsive non-muscle invasive bladder cancer: Do current recommendations really reflect clinically meaningful outcomes?

Authors:  Marian S Wettstein; David Naimark; Thomas Hermanns; Jaime O Herrera-Caceres; Ardalan Ahmad; Michael A S Jewett; Girish S Kulkarni
Journal:  Cancer Med       Date:  2020-03-12       Impact factor: 4.452

4.  Associations between safety, tolerability, and toxicity and the reporting of health-related quality of life in phase III randomized trials in common solid tumors.

Authors:  Ramy R Saleh; Nicholas Meti; Domen Ribnikar; Hadar Goldvaser; Alberto Ocana; Arnoud J Templeton; Bostjan Seruga; Eitan Amir
Journal:  Cancer Med       Date:  2020-09-04       Impact factor: 4.452

5.  Evidence-Based Medicine in Oncology: Commercial Versus Patient Benefit.

Authors:  Volker Schirrmacher; Tobias Sprenger; Wilfried Stuecker; Stefaan W Van Gool
Journal:  Biomedicines       Date:  2020-07-23
  5 in total

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