Table 1.

Calendar days from initiation to final approval for each major process step required to activate a phase III study at the ECOG

No.Median (d)Range (d)Number of revision loopsRange of loops
Concept development
    Includes study chair effort57237-95
    Includes only ECOG effort111810-62
Executive review13115-4511
CTEP concept review1511320-61191-3
Protocol development1643957-968
CTEP protocol review*161295-783131-4
Forms/data management1540150-1,320
Common data element compliance*61144-59331-3
Grant development11750294-99313
Regulatory affairs development1102102
FDA review*14646
CIRB review*1411647-739121-9
CTEP final approval13142-134
Preactivation activities14242
Activation13808435-1,604
  • NOTE: The reasons for unequal sample sizes are as follows: in concept development, not all records were maintained by committee chairs to include study chair effort time; common data element, occurred midway through the study period, hence, not all studies required this step; grant development, captured only if additional funding was requested from a pharmaceutical firm; regulatory affairs, completed only if the source of a drug was being received directly from a company; FDA review, necessary only if ECOG is involved with IND filing process; although initial FDA review is within 30 to 45 d, studies required multiple loops to attain final FDA approval. Days do not sum as process steps overlap.

  • * Processes external to ECOG.