Introduction

It is perhaps too often the case that the design of a trial is established from the first discussions about potential treatments and remains unchallenged thereafter. There are few trials which would not benefit from taking a step back and reviewing whether the trial is as good as it can be. Time pressures are often against this, as the process ofgaining funding and ethical approval for a trial can be lengthy and replete with deadlines. But given the time, effort and expense which go into the planning, conduct and analysis of a clinical trial, and the continuing struggle to enter more cancer patients into trials, a little more time spent considering whether opportunities are being exploited can be time well spent. The following sections discuss alternative designs, beginning with the simplest, and looking at each stage at questions which should be asked about the number of treatment arms and the number and timing of randomizations.

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