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From adaptive licensing to adaptive pathways: Delivering a flexible life‐span approach to bring new drugs to patients
2 references·15 citing·35 second hop
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References

  • 2014Clinical development success rates for investigational drugs2,531 cited
  • 2007Stratified medicine: strategic and economic implications of combining drugs and clinical biomarkers510 cited

Cited by

  • 2017Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future142 cited
  • 2019New drugs: where did we go wrong and what can we do better?130 cited
  • 2019Unmet Medical Need: An Introduction to Definitions and Stakeholder Perceptions125 cited
  • 2020Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States96 cited
  • 2015Approvals of drugs with uncertain benefit–risk profiles in Europe93 cited
  • 2015Early market access of cancer drugs in the EU89 cited
  • 2020Decision Making Under Uncertainty: Comparing Regulatory and Health Technology Assessment Reviews of Medicines in the United States and Europe83 cited
  • 2018The use of real-world data in cancer drug development76 cited
  • 2018Managed Entry Agreements for Pharmaceuticals in the Context of Adaptive Pathways in Europe71 cited
  • 2016How aligned are the perspectives of EU regulators and HTA bodies? A comparative analysis of regulatory‐HTA parallel scientific advice65 cited
  • 2016Risk‐based decision making and ethical considerations in donor compensation for plasma‐derived medicinal products35 cited

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  • 2019Regulation and regime: the comparative politics of adaptive regulation in synthetic biology32 cited
  • 2019Real-World Evidence Gathering in Oncology: The Need for a Biomedical Big Data Insight-Providing Federated Network18 cited
  • 2021Unmet Medical Need as a Driver for Pharmaceutical Sciences – A Survey Among Scientists15 cited
  • 2024The FAIRification of research in real‐world evidence: A practical introduction to reproducible analytic workflows using Git and R7 cited