The accepted opinion in the oncological community is that patients are better off when treated within the context of a clinical trial. However, based upon a critical analysis of the available literature, there is little unbiased evidence of outcome improvement. Important ethical considerations must be taken into account. Also a lot of problems arise with the regulation of the trials and the administrative burden. Patients must be enrolled in a clinical trial on the basis of improving treatment options for future patients.

(BELG J MED ONCOL 2014;8(3):94–7)