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Stop in the name of ethics

A French research team is criticised for allowing a clinical trial to continue even though preliminary results suggested the drug therapies were ineffective.

John Borchardt

A team of French cancer researchers is being criticised for allowing a clinical trial to continue even though preliminary results had suggested the drug therapies being evaluated were of little value. Dr. Sylvie Négrier of the Centre Léon Bérard in Lyon and colleagues found that patients with advanced kidney cancer derived no benefit from a combination of interleukin-2 and interferon alfa-2a with and without the chemotherapy drug fluorouracil (J Clin Oncol 2000 18:4009-4015). A strongly worded editorial published in the same issue of the Journal of Clinical Oncology criticised the French oncologists' decision to "disregard their own study design" and continue the study, even though an interim analysis of the data was "disappointing" (J Clin Oncol 2000 18:4007-4009).

Editorial authors Dr. Sophie Fosså and Dr. Eva Skovlund of the Norwegian Radium Hospital in Oslo were particularly concerned that patients continued to be enrolled in the study...

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