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Table 2 Effect of surrogate outcomes on options for designing pivotal clinical trials

From: Surrogate endpoints in oncology: when are they acceptable for regulatory and clinical decisions, and are they currently overused?

  Traditional Scenario 1: speed up drug approval Scenario 2: increased market share TDM-1 Pertuzumab
Population Relapsed Relapsed Newly Diagnosed 2nd line 1st Line
Market share of population Small Small Large   
Outcome Hard Surrogate Surrogate OS PFS
Event rate 100% experience event in 1 year 100% experience event in 6 months 100% experience event in 1 year OS benefit demonstrated after 16 months of follow-up PFS benefit not demonstrated until 19.3 months
Time to complete study 1 year 6 months 1 year 42 months between enrollment and results 40 months between enrollment and results
  1. OS overall survival, PFS progression-free survival
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