BMJ  2005;331 (3 December), doi:10.1136/bmj.331.7528.0

Uncertainty of outcome removes ethical dilemma in trials of cancer drugs

In clinical trials of new child cancer drugs, the experimental treatments for childhood cancer are just as likely to be inferior to the standard comparator treatment as they are to be superior. Such uncertainty makes it easier for patients to decide whether to participate in such trials, and for researchers to justify the clinical trial system, which has led to advances in treatment of several childhood cancers. After analysing a consecutive series of 126 published and unpublished randomised phase III trials performed between 1955 and 2000 under the aegis of the Children's Oncology Group, Kumar and colleagues (p 1295) found no evidence of the value of new experimental treatments being confidently predictable in advance.

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Relevant Article

Are experimental treatments for cancer in children superior to established treatments? Observational study of randomised controlled trials by the Children's Oncology Group

Ambuj Kumar, Heloisa Soares, Robert Wells, Mike Clarke, Iztok Hozo, Archie Bleyer, Gregory Reaman, Iain Chalmers, and Benjamin Djulbegovic
BMJ 2005 331: 1295. [Abstract] [Full Text] [PDF]