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Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States
9 references·1 citing·29 second hop
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States (2020)Approval of Cancer Drugs With Uncertain T…New drugs: where did we go wrong and what can we do better? (2019)New drugs: where did we go wr…Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Assessment of the Clinical Be…A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics (2018)A 25-Year Experience of US Fo…Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration (2017)Characteristics of Preapprova…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…Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014 (2016)Regulatory approval of pharma…Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study (2015)Trends in utilization of FDA …From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients (2015)From adaptive licensing to ad…Accelerated Approval of Oncology Products: The Food and Drug Administration Experience (2011)Accelerated Approval of Oncol…Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000–20: a retrospective analysis (2024)Population-health impact of n…Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers (2007)Clinical development success rates for investigational drugs (2014)Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future (2017)Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions (2019)Characteristics of Clinical Trials to Support Approval of Orphan vs Nonorphan Drugs for Cancer (2011)Clinical benefit, price and approval characteristics of FDA-approved new drugs for treating advanced solid cancer, 2000–2015 (2017)Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017 (2020)Comparison of Evidence of Treatment Effects in Randomized and Nonrandomized Studies (2001)Examining the Use of Real‐World Evidence in the Regulatory Process (2019)Population Adjustment Methods for Indirect Comparisons: A Review of National Institute for Health and Care Excellence Technology Appraisals (2019)Marketing Authorization Applications Made to the European Medicines Agency in 2018–2019: What was the Contribution of Real‐World Evidence? (2021)Publication of NIH funded trials registered in ClinicalTrials.gov: cross sectional analysis (2012)Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 (2020)Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval (2024)A standardised, generic, validated approach to stratify the magnitude of clinical benefit that can be anticipated from anti-cancer therapies: the European Society for Medical Oncology Magnitude of Clinical Benefit Scale (ESMO-MCBS) (2015)Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets (2018)The replicability crisis and public trust in psychological science (2018)American Society of Clinical Oncology Statement: A Conceptual Framework to Assess the Value of Cancer Treatment Options (2015)Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study (2020)Generating comparative evidence on new drugs and devices after approval (2020)Generating comparative evidence on new drugs and devices before approval (2020)Net Health Benefits (1998)Methods for the Economic Evaluation of Health Care Programmes (2005)The NICE Cost-Effectiveness Threshold (2008)Cardiovascular Drug Development (2015)Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (2021)Trends in the approval of cancer therapies by the FDA in the twenty-first century (2023)Pricing of pharmaceuticals is becoming a major challenge for health systems (2020)
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References

  • 2017Availability 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 2009-13600 cited
  • 2019Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval302 cited
  • 2018A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics298 cited
  • 2011Accelerated Approval of Oncology Products: The Food and Drug Administration Experience212 cited
  • 2015From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients196 cited
  • 2017Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration196 cited
  • 2015Trends in utilization of FDA expedited drug development and approval programs, 1987-2014: cohort study189 cited
  • 2016Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014186 cited
  • 2019New drugs: where did we go wrong and what can we do better?130 cited

Cited by

  • 2024Population-health impact of new drugs recommended by the National Institute for Health and Care Excellence in England during 2000–20: a retrospective analysis85 cited

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