Journal article

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

Sian C Hicks, Rebecca E James, Nicole Wong, Niall C Tebbutt, Kate Wilson

MEDICAL JOURNAL OF AUSTRALIA | AUSTRALASIAN MED PUBL CO LTD | Published : 2009

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..

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University of Melbourne Researchers