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Meta-Analysis
. 2011 Aug;47(12):1772-8.
doi: 10.1016/j.ejca.2011.02.013. Epub 2011 Mar 21.

Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis

O Amit  1 , F Mannino, A M Stone, W Bushnell, J Denne, J Helterbrand, H U Burger
Affiliations
Meta-Analysis

Blinded independent central review of progression in cancer clinical trials: results from a meta-analysis

O Amit et al. Eur J Cancer. 2011 Aug.

Abstract

Purpose: Progression free survival (PFS) is increasingly used as a primary end-point in oncology clinical trials. This paper provides observations and recommendations on the use of a blinded independent central review (BICR) for progression.

Patients and methods: The findings and recommendations are based on extensive simulations and a meta-analysis based on 27 previously conducted randomised phase III trials with BICR performed by the Pharmaceutical Research and Manufacturers Association (PhRMA) sponsored PFS Independent Review Working Group.

Results: Results of the meta-analysis demonstrate a strong correlation between LE and BICR estimates of treatment effect (R=0.947). Further, differences between treatment groups in discordance rates predict the differences between LE and BICR estimates of treatment effect supporting the use of a sample-based BICR on a subgroup of patients.

Conclusion: The meta-analysis demonstrates that local evaluation (LE) provides a reliable estimate of the treatment effect with little evidence for systematic evaluation bias. Therefore, when a trial is blinded or a large effect on PFS is observed a BICR may not be warranted. When a BICR is warranted, a sample-based BICR may provide a reduction in operational complexity without compromising the credibility of trial results. While for large trials that are not adequately blinded a sample-based BICR may be recommended. A full BICR should be considered in the case of smaller trials or in situations in which there is a particular need to increase the confidence in the LE results.

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