SZodixStudyAcademic Library
ShelvesOpen access
Study · an open academic library·Metadata from OpenAlex (CC0)·Shelves·OpenAlex metadata, de-duplicated
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval
1 references·12 citing·27 second hop
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval (2019)Assessment of the Clinical Benefit of Can…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…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…Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval (2024)Clinical Benefit and Regulato…Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy (2023)Special FDA designations for …Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019 (2022)Cancer Therapy Approval Timin…Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study (2021)Regulatory and clinical conse…Pricing of pharmaceuticals is becoming a major challenge for health systems (2020)Pricing of pharmaceuticals is…Generating comparative evidence on new drugs and devices before approval (2020)Generating comparative eviden…Generating comparative evidence on new drugs and devices after approval (2020)Generating comparative eviden…Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe (2020)Decision Making Under Uncerta…Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016 (2020)Clinical Trial Evidence Suppo…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…New drugs: where did we go wrong and what can we do better? (2019)New drugs: where did we go wr…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)External validity of randomised controlled trials: “To whom do the results of this trial apply?” (2005)Evidence Synthesis for Decision Making 2 (2012)Increasing value and reducing waste in research design, conduct, and analysis (2014)The cost of drug development: A systematic review (2011)The $2.6 Billion Pill — Methodologic and Policy Considerations (2015)Country-Level Cost-Effectiveness Thresholds: Initial Estimates and the Need for Further Research (2016)Access and Unmet Needs of Orphan Drugs in 194 Countries and 6 Areas: A Global Policy Review With Content Analysis (2020)Lowering drug prices and enhancing pharmaceutical affordability: an analysis of the national volume-based procurement (NVBP) effect in China (2021)Accelerated Approval of Oncology Products: The Food and Drug Administration Experience (2011)A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics (2018)Meta-analysis in clinical trials (1986)Measuring inconsistency in meta-analyses (2003)The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: Guidelines for Reporting Observational Studies (2007)Influence of trial sample size on treatment effect estimates: meta-epidemiological study (2013)Clinical development success rates for investigational drugs (2014)FDA Approval and Regulation of Pharmaceuticals, 1983-2018 (2020)The high price of anticancer drugs: origins, implications, barriers, solutions (2017)Trends in the approval of cancer therapies by the FDA in the twenty-first century (2023)Net Health Benefits (1998)Methods for the Economic Evaluation of Health Care Programmes (2005)The NICE Cost-Effectiveness Threshold (2008)Cancer medicines on the WHO Model List of Essential Medicines: processes, challenges, and a way forward (2022)
this work references cited by second hop

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

Cited by

  • 2020Pricing of pharmaceuticals is becoming a major challenge for health systems145 cited
  • 2023Special FDA designations for drug development: orphan, fast track, accelerated approval, priority review, and breakthrough therapy133 cited
  • 2019New drugs: where did we go wrong and what can we do better?130 cited
  • 2024Clinical Benefit and Regulatory Outcomes of Cancer Drugs Receiving Accelerated Approval129 cited
  • 2021Regulatory and clinical consequences of negative confirmatory trials of accelerated approval cancer drugs: retrospective observational study112 cited
  • 2020Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 201697 cited
  • 2020Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States96 cited
  • 2020Generating comparative evidence on new drugs and devices after approval87 cited
  • 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
  • 2020Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe83 cited
  • 2022Cancer Therapy Approval Timings, Review Speed, and Publication of Pivotal Registration Trials in the US and Europe, 2010-2019

Only edges whose both ends are imported exist here. Widen the year window, or show the whole map. Back to the work

83 cited
  • 2020Generating comparative evidence on new drugs and devices before approval79 cited