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Adverse effects of a multicentre system for ethics approval on the progress of a prospective multicentre trial of cancer treatment: how many patients die waiting?

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Abstract:

Abstract Background:

As cancer survival is improving approximately by 1–2% per year, delays in the clinical trials that lead to that improvement could cost lives. Aims:

To review the process of ethics committee approval for a multicentre clinical trial of cancer treatment and to estimate the delay it will cause in obtaining the results and the effects of such delays on survival for all cancers in Australia. Methods:

A survey was sent to each of the 15 centres participating in the study to obtain details about submissions they had made to their ethics committees and the replies received from them. Results:

The survey response rate was 100%. The average time required to complete an ethics submission was 12 h, and the average length of time for a final reply was 70 days. Wide variation was noted in the replies, 40% were considered constructive. Most centres said the effort in ethics submissions is sufficient to limit participation in other clinical trials that are available. Conclusion:

The multicentre system of ethics approval has significantly delayed this multicentre trial and may delay advances in cancer care. Extrapolating this delay to determine an influence on improvements in cancer survival suggests that it may be responsible for 60 cancer deaths per year. A method for measuring the effect on the shape of the accrual curve is defined, and the term DIABOLECAL (Delays in Accrual Brought On Largely by Ethics Committee Activity Lag-time) is proposed to describe it. Attempts to overcome this problem have been introduced overseas.

Keywords: clinical trial; medical ethics; radiotherapy

Document Type: Research Article

DOI: http://dx.doi.org/10.1111/j.1445-5994.2007.01451.x

Affiliations: 1: Collaboration for Cancer Outcomes Research and Evaluation, Sydney, New South Wales 2: Department of Epidemiology and Population Studies, Australian National University, Canberra, Australian Capital Territory, Australia

Publication date: October 1, 2007

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