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Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs
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Weighing of Evidence by Health Technology Assessment Bodies: Retrospective Study of Reimbursement Recommendations for Conditionally Approved Drugs (2018)Weighing of Evidence by Health Technology…Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review (2017)Postapproval studies of drugs…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…Accelerated Approval and Expensive Drugs — A Challenging Combination (2017)Accelerated Approval and Expe…Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries (2016)Relative effectiveness assess…Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014 (2016)Regulatory approval of pharma…Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints (2016)Quality of Life, Overall Surv…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…Approvals of drugs with uncertain benefit–risk profiles in Europe (2015)Approvals of drugs with uncer…New FDA Breakthrough-Drug Category — Implications for Patients (2014)New FDA Breakthrough-Drug Cat…Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration (2013)Development Times, Clinical T…Interrater reliability: the kappa statistic (2012)Interrater reliability: the k…Equivalences of weighted kappas for multiple raters (2011)Equivalences of weighted kapp…Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma (2008)Balancing early market access…Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures (2005)Ten years of marketing approv…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)New drugs: where did we go wrong and what can we do better? 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References

  • 2012Interrater reliability: the kappa statistic19,799 cited
  • 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
  • 2008Balancing early market access to new drugs with the need for benefit/risk data: a mounting dilemma229 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
  • 2017Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review121 cited
  • 2014New FDA Breakthrough-Drug Category — Implications for Patients119 cited
  • 2005Ten years of marketing approvals of anticancer drugs in Europe: regulatory policy and guidance documents need to find a balance between different pressures109 cited
  • 2015Approvals of drugs with uncertain benefit–risk profiles in Europe93 cited
  • 2017Accelerated Approval and Expensive Drugs — A Challenging Combination81 cited
  • 2013Development Times, Clinical Testing, Postmarket Follow-up, and Safety Risks for the New Drugs Approved by the US Food and Drug Administration

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75 cited
  • 2016Quality of Life, Overall Survival, and Costs of Cancer Drugs Approved Based on Surrogate Endpoints74 cited
  • 2016Relative effectiveness assessments of oncology medicines for pricing and reimbursement decisions in European countries59 cited
  • 2011Equivalences of weighted kappas for multiple raters27 cited
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