Strength of Validation for Surrogate End Points Used in the US Food and Drug Administration’s Approval of Oncology Drugs

Eitemau Tebyg

• An Overview of Cancer Drugs Approved by the US Food and Drug Administration Based on the Surrogate End Point of Response Rate
  gan: Chen, Emerson Y., et al.
  Cyhoeddwyd: (2019)
• Potential Cost Implications for All US Food and Drug Administration Oncology Drug Approvals in 2018
  gan: DeMartino, Patrick C., et al.
  Cyhoeddwyd: (2020)
• FDA Acceptance of Surrogate End Points for Cancer Drug Approval: 1992-2019
  gan: Chen, Emerson Y., et al.
  Cyhoeddwyd: (2020)
• Limitations in Clinical Trials Leading to Anticancer Drug Approvals by the US Food and Drug Administration
  gan: Hilal, Talal, et al.
  Cyhoeddwyd: (2020)
• Oncology Drug Development and Approval of Systemic Anticancer Therapy by the U.S. Food and Drug Administration
  gan: Martell, Robert E., et al.
  Cyhoeddwyd: (2013)