Close to 3 years after the July 24th 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on the  “Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies” that encouraged further investigation of the merits of possible audit implementations that identify presence or absence of bias in the local evaluator of patient status- many questions still remain.

In the past, when progression-free survival (PFS) was the primary efficacy endpoint of an oncology clinical trial, the FDA has generally required blinded independent radiologic review (BICR) of scans under the assumption that local evaluation (LE) or investigator assessment (INV) could be biased. Thus the role of BICR was intended to standardize the criteria interpretation and mitigate potential evaluation bias by investigators. In recent years this assumption has been challenged and a number of papers suggest that there is little evidence for a systematic bias at the site. In addition, challenges associated with site - central discordance, a significant risk factor for informative censoring, have triggered calls for a re-evaluation of a need of BICR for clinical trials.

In particular, while there are a growing number of publications on the methods available we witness a search for more clarity with respect to:

• the cost implications of audits as observed so far
• lessons learned from the early adopters of the published methods and alternative methods
• nature and suitability of the central and site review models for the studies included in the original meta-analysis
• the further definition of the statistical methods in particular in the context with the PhRMA method modifications that would allow central audit reads to occur before the data base lock and the breaking of the blind
• a discussion of the appropriate indications and trial settings

The aim of this meeting is to discuss what we have learned on the audit methods: when, what and how an audit plan (rather than a full independent review) should be implemented.  The agenda will be designed to facilitate discussions.  Participants should leave with a better understanding of the audit method options, the key challenges and advantages and some tools for cost-benefit analysis of the implementation of such audit plans.  A report of the insights and recommendations of this group is an expected outcome of the meeting.

This program is cosponsored with RSNA