Correspondence/Reply: Central Institutional Review Board–Facilitated Review Metrics Omit Critical Components

1) CORRESPONDENCE
Central Institutional Review Board–Facilitated Review Metrics Omit Critical Components
Michael S. Katz, Mary L. Smith
Patient Representative Committee, Eastern Cooperative Oncology Group, Philadelphia, PA

To the Editor:

"As cancer survivors and patient advocates, we must take issue with calculations of the impact of the central institutional review board (CIRB) on local institutional review board (IRB) protocol review times and societal costs by Wagner et al.1 The authors' definitions of these metrics omit critical components......Thus, the net impact on IRB review times, which determine how quickly a protocol can move from National Cancer Institute approval to putting patients on-study are actually slower by 66 to 76 days than a stand-alone local review. The suggestion, therefore, that there are "benefits of a more predictable and faster approval process" is not accurate.""

2) CORRESPONDENCE - Reply to M.S. Katz et al 

"Recent internal data from National Cancer Institute show that these changes have decreased the length of CIRB review, defined as application receipt to approval, from a median of 95.5 days in 2008 to 45 days for the six trials using the new processes."