An Audit Plan in Oncology Clinical Trials

• Activity Number: 412
• Type: Topic Contributed
• Date/Time: Tuesday, August 11, 2015 : 2:00 PM to 3:50 PM
• Sponsor: Biopharmaceutical Section
• Author(s): Steven Sun*
• Companies: Johnson & Johnson
• Keywords: cancer trial ; progression free survival ; audit plan

Abstract

Assessment of Progression-free survival (PFS) by Independent Review Committee (IRC) is often required by the FDA when PFS is the primary endpoint in cancer clinical studies. On July 24th 2012, FDA hosted an ODAC (Oncologic Drug Advisory Committee) meeting about the "Evaluation of Radiologic Review of Progression-free Survival in Non-Hematologic Malignancies". A high degree of association between investigator (INV) and IRC-determined PFS treatment effects, as measured by HR, was observed from retrospective analyses of more than 25 studies. This high level of correlation at the study level was uniformly observed, irrespective of the discordance rate at the subject level. In this context, the ODAC meeting concluded that a complete IRC review might not be necessary for every single clinical trial and auditing of a random sample of the clinical trial subject data might be sufficient. Audit plan is often requested by the FDA for studies with INV-determined PFS as the primary endpoint since then. In this talk, we will discuss the need of audit plans and challenges associated with implementation of an audit plan from both operational and statistical perspective.