TL33: PFS - central vs local
Zhiying (Cindy) Xu, Novartis  Tingting Yi, Novartis  *Lihui Zhao, Novartis 

Keywords: PFS, central, local, audit

In July 2012, Oncology Drugs Advisory Committee (ODAC) convened a meeting to discuss the agenda that “ involves the evaluation of radiographic review in randomized clinical trials using progression-free survival, PFS, as a primary endpoint in non-hematologic malignancies. They will consider the merits of an independent audit of investigator progression assessment in a prespecified subgroup of patients instead of an independent review of all progression assessments.” The meta analyses by Zhang et al from FDA (Evaluation of Blinded Independent Central Review of Tumor Progression in Oncology Clinical Trials: A Meta-analysis) was presented on this meeting, and subsequently published in Therapeutic Innovation & Regulatory Science 2013 47: 167 originally published online 7 September 2012. How has the above impacted the practice in your company? If the study is truly blinded, are you still implementing a central review? Which audit method did you apply and how was your experience with them? There are some general suggestions from this ODAC that several situations where a random sample-based IRC audit may not be appropriate: modest progression-free survival, small studies, and certain tumor types. How did you approach these situations?