A case study evaluation of ethics review systems for multicentre clinical trials

Abstract

Objective: To evaluate the difference in time taken for ethics and site governance approval for multicentre clinical trials using two different systems of ethics review. Design: We evaluated the times to final ethics and governance approval for two international, multicentre clinical trials of treatment for metastatic colorectal cancer: the MAX trial, using a non-centralised ethics review system, and the CO.20 trial, using the new New South Wales centralised ethics review system. Main outcome measure: Time from trial submission to overall study approval. Results: The median time taken to obtain ethics approval for the MAX trial at 16 NSW sites was 100 days (range, 36-161 days). The median ti..