ODAC considers streamlining PFS reviews in non-hematologic cancer trials

FDA's Oncologic Drugs Advisory Committee on Tuesday generally agreed with an agency proposal that would ease requirements for the independent evaluation of radiographic review in trials for non-hematologic malignancies that use progression-free survival (PFS) as a primary endpoint. The proposal would allow sponsors to commission an independent audit of only a random sample of radiographic scans instead of a complete review of all scans, as FDA requires.

However, panelists expressed a need for more analysis of the two proposed statistical methods to interpret the audits and the thresholds that would trigger a complete review of all scans. The first method uses hazard ratios to evaluate the correlation between the audit and the original investigator assessments. The second evaluates the differential discrepancy rates of the audit compared to the original assessment between the trial's treatment and control arms. ...