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Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

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References

2014Clinical development success rates for investigational drugs2,531 cited
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2015A 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)817 cited
2016Updating the American Society of Clinical Oncology Value Framework: Revisions and Reflections in Response to Comments Received655 cited
2015Five Years of Cancer Drug Approvals301 cited
2016Assessment of Overall Survival, Quality of Life, and Safety Benefits Associated With New Cancer Medicines151 cited

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2020Generating comparative evidence on new drugs and devices after approval87 cited
2020Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe83 cited
2020Generating comparative evidence on new drugs and devices before approval79 cited
2021Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015–202071 cited

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