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Seeking Clarity in the Audit Approach

Many questions still remain several years after the July 2012 ODAC (Oncologic Drug Advisory Committee) Meeting on the "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies." Further investigation was recommended into the utility of taking an audit approach (central reads of a test sample) to identify potential bias in the local evaluation (LE) of patient data.

During Bioclinica's recently held webinar on 'Critical Regulatory Considerations in Imaging Trials,' attendees were asked to identify any fears associated with utilizing the Auditing Approach in central imaging trial design. The results of the poll are summarized in the graph below. It is interesting to note that the main worry continues to be the non-acceptance by regulators of their trial data during study-filing – confirming industry-wide apprehension over this recent alternative to guidance of past.

Audit methodology review and other discussion takeaways:

  • Certain activities are still required if images are collected, and any portion of them analyzed centrally. There are two proposed audit methodologies, both of which would keep prospective image collection in place, since there is a possibility that a complete central review would be needed. If scans are not collected prospectively during a trial, experience shows that retrospective collection of image data typically results in 30% of the necessary image data being unavailable.
  • Further concerns relate to the auditability of Investigator Site analysis, especially if used as the primary endpoint in regulatory submissions.  Investigators may contract external resources to support image analysis and reproducibility in the form of standard processes as well as system auditability can be challenging.
  • Potential cost savings? Additional costs may be introduced that potentially offset any meaningful savings by only centrally analyzing samples of images. These costs, may include but are not limited to:
    • Central imaging laboratories reduce variability.  Relying on many local site readers increase variability in the endpoint measurements, which may require larger trials with more subjects.
    • Investigator sites may not be prepared to have their procedures and techniques scrutinized during a regulatory inspection.
    • Local site readers whose performance falls outside of acceptable inter/intra observer thresholds. Inter/intra reader monitoring implementation across a network of investigator sites is a difficult and expensive proposition.
    • The services of senior level statisticians would be required to model sample methodology and develop the techniques for comparing the central physician analysis sample to the local reads.
  • Clarity is still being sought when deciding between the need for a full blinded independent radiologic review (BICR) or the alternative auditing methods. There exists many critical points to consider with adoption of this new methodology. Early in the protocol planning stage, consultation with a medical imaging provider, highly experienced with working alongside regulatory agencies, is critical to trial success. View the full on demand webinar for additional insight: Critical Regulatory Considerations for Imaging Trials: What You Need to Know
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Critical Regulatory Considerations for Imaging Trials: What You Need to Know

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