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Annals of Oncology Advance Access published online on October 29, 2009
Annals of Oncology, doi:10.1093/annonc/mdp478
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© The Author 2009. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Influence of an independent review committee on assessment of response rate and progression-free survival in phase III clinical trials

P. A. Tang, G. R. Pond and E. X. Chen*

Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, Toronto, Ontario, Canada

* Correspondence to: Dr E. X. Chen, Department of Medical Oncology and Hematology, Princess Margaret Hospital, University Health Network, 610 University Avenue, Suite 5-719, Toronto, Ontario M5G 2M9, Canada. Tel: +1 416-946-2263; Fax: +1 416-946-4467; E-mail: eric.chen{at}uhn.on.ca

Background: Our objective was to determine the variability in assessment between investigators (INV) and independent review committees (IRC) for response rate (RR) and progression-free survival (PFS).

Methods: Phase III trials reporting INV and IRC assessments were identified. The difference in end point assessment (IRC – INV) across all study arms was determined. A random-effects model was used to calculate the mean difference between INV and IRC RR as well as PFS. Differences in estimated benefits of treatment (experimental – control) between IRC and INV were determined.

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

Conclusion: 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.

independent review committee, progression-free survival, response rate, RECIST

Received for publication January 23, 2009. Revision received September 1, 2009. Accepted for publication September 16, 2009.


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