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The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020
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The evidence base of US Food and Drug Administration approvals of novel cancer therapies from 2000 to 2020 (2023)The evidence base of US Food and Drug Adm…The On- and Off-Ramps of Oncology Accelerated Approval (2022)The On- and Off-Ramps of Onco…Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Cancer Therapy Approval Timin…FDA Approval and Regulation of Pharmaceuticals, 1983-2018 (2020)FDA Approval and Regulation o…Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 (2020)Clinical Trial Evidence Suppo…Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Assessment of the Clinical Be…Analysing data and undertaking meta‐analyses (2019)Analysing data and undertakin…The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs (2018)The Comparative Effectiveness…How to use FDA drug approval documents for evidence syntheses (2018)How to use FDA drug approval …Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review (2017)Postapproval studies of drugs…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 (2017)Availability of evidence of b…Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines (2016)Assessment of Overall Surviva…Analysing Data and Undertaking Meta‐Analyses (2008)Analysing Data and Undertakin…The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies (2007)The Strengthening the Reporti…The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies (2007)The Strengthening the Reporti…Measuring inconsistency in meta-analyses (2003)Measuring inconsistency in me…Meta-analysis in clinical trials (1986)Meta-analysis in clinical tri…Bias in meta-analysis detected by a simple, graphical test (1997)Synthesizing information systems knowledge: A typology of literature reviews (2014)Basics of meta‐analysis: I 2 is not an absolute measure of heterogeneity (2017)How to perform a meta-analysis with R: a practical tutorial (2019)Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement (1999)The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomised trials (2001)Strengthening the Reporting of Observational Studies in Epidemiology (STROBE): Explanation and Elaboration (2007)CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials (2010)CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials (2010)Better reporting of interventions: template for intervention description and replication (TIDieR) checklist and guide (2014)Costs, Risks, and Benefits of Surgery. 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  • 2022Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

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83 cited
  • 2022The On- and Off-Ramps of Oncology Accelerated Approval81 cited
  • 2018How to use FDA drug approval documents for evidence syntheses29 cited
  • 2018The Comparative Effectiveness of Innovative Treatments for Cancer (CEIT-Cancer) project: Rationale and design of the database and the collection of evidence available at approval of novel drugs20 cited
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