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I start it is important that I establish my credibility as my somewhat eccentric career allows me an unusual insight into the problem. First of all I come from a family with a bad history of breast cancer, which in part fuelled my zeal for entering this sub-specialty. Next I am a surgeon who has been at the front line of breast cancer treatment for over 30 years and during the latter half of that experience have been looking after the 'casualties' of the screening programme in the UK. I know a lot about the mechanics of screening, having been given the task of setting up the programme in the South East of England in my role as Professor of Surgery at Kings College Hospital in 1987/88 and then serving on our national screening committee until 1997. Finally, I am well equipped to discuss the minutiae of randomized controlled trials (RCT) as founder of the first clinical trials centre in the UK in 1980 and as principle investigator of the largest collaborative group for breast cancer trials in Europe, until my retirement in June of this year. 1 I know a lot about the quality issues in running RCT and my group established many of these principles in the late 1970s. Let us start therefore with a checklist of some of the essentials for running high quality RCT that are now enshrined in the CONSORT principles on the conduct and reporting of such trials. 2 —The study population must be precisely defined for prospective entry and exclusion criteria. —All patients must be recruited with individual informed consent. —Randomization must be blinded in such a way that it is impossible for the investigator to predict what the next allocation is going to be. —There should be a priori power calculations based on the primary end points in order to avoid type I and type II errors. —The primary endpoints should be 'event free' survival, which include deaths from other causes before a breast cancer event as well as breast cancer specific events. This analysis should be triggered at a predetermined threshold on the advice of an independent data monitoring and safety committee (DMSC). —The secondary endpoints should be all-cause mortality and cause-specific mortality again triggered by the advice of the DMSC. —A priori 'stopping rules' should be activated by the DMSC if there are unexpected adverse events or if the advantage …

Commentary: False premises, false promises and false positives--the case against mammographic screening for breast cancer