Table 2.

Details of calendar days per entity/organization and process segment for two phase III studies activated by the ECOG

Concept development and reviewInitial protocol development*Protocol reviewCIRB reviewCTEP final review and study activationTotal
Fast study
    ECOG/study chair17271194242346
    CTEP1094310162
    CIRB9191
    Total281716213352599
Slow study
    Study chair492795171
    ECOG591892149399
    CTEP98551272282
    CIRB123123
    Total206189844942975
  • NOTE: These totals include the days listed above plus days from executive approval through the end of CTEP concept approval (260 and 150 d, respectively).

  • * Total actual protocol development time was 331 d (for the fast study) and 339 d (for the slow study).