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Annals of Oncology Advance Access first published online on February 27, 2008
This version published online on April 9, 2008
Annals of Oncology, doi:10.1093/annonc/mdn042
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© The Author 2008. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved. For permissions, please email: journals.permissions@oxfordjournals.org

Stopping a trial early in oncology: for patients or for industry?

F. Trotta1, G. Apolone2, S. Garattini2 and G. Tafuri1,3,*

1 Italian Medicines Agency (AIFA), Rome
2 Mario Negri Institute for Pharmacological Research, Milan, Italy
3 Utrecht University, UIPS Institute for Drug Innovation, Utrecht, The Netherlands

* Correspondence to: Dr G. Tafuri, Italian Medicines Agency (AIFA), via della Sierra Nevada 60, 00144 Rome, Italy. Tel: +39 6 59784713, Fax: +39 6 59784717; E-mail: g.tafuri{at}aifa.gov.it

Background: The aim of this study is to assess the use of interim analyses in randomised controlled trials (RCTs) testing new anticancer drugs, focussing on oncological clinical trials stopped early for benefit.

Materials and methods: All published clinical trials stopped early for benefit and published in the last 11 years, regarding anticancer drugs and containing an interim analysis, were assessed.

Results: Twenty-five RCTs were analysed. The evaluation of efficacy was protocol planned through time-related primary end points, >40% of them overall survival. In 95% of studies, at the interim analysis, efficacy was evaluated using the same end point as planned for the final analysis. As a consequence of early stopping after the interim analysis, ~3300 patients/events across all studies were spared. More than 85% of the RCTs published in the last 3 years were used for registration purposes.

Conclusion: Though criticism of the poor quality of oncological trials seems out of place, unfortunately early termination raises new concerns. The relation between sparing patients and saving time and trial costs indicates that there is a market-driven intent. We believe that only untruncated trials can provide a full level of evidence which can be translated into clinical practice without further confirmative trials.

anticancer drugs, EMEA, FDA, end point, interim analysis, RCT

Received for publication December 18, 2007. Revision received January 25, 2008. Accepted for publication January 28, 2008.


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