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Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials
Annals of Oncology, 11/04/09

Tang PA et al. – INV overestimate RR compared with IRC. Given the variability in assessing RR and PFS between INV and IRC, an IRC should be considered if the primary end point is on the basis of assessments of changes in tumor lesions.

Methods

Phase III trials reporting INV and IRC assessments identified
Difference in end point assessment (IRC – INV) across all study arms determined
Random-effects model used to calculate mean difference between INV and IRC RR as well as PFS
Differences in estimated benefits of treatment (experimental – control) between IRC and INV determined

Results

Twenty-one trials included (18 RR, 8 PFS)
Estimated mean difference between IRC- and INV-determined RR 4.57% [95% confidence interval (CI) 2.95% to 6.19%].
For median PFS, estimated mean difference was –0.19 (95% CI –0.68 to 0.29) months
Difference in estimated benefits of treatment ranged from –7.0% to 7.2% for RR and –2.0 to +2.4 months for PFS; no evidence of systemic bias by INV (P = 0.54 for RR and 0.31 for PFS)

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