This chapter has covered the issues involved in 'positioning' a new trial; establishing the need or otherwise for a new trial in the context or previous and current work and clarifying the broad goals of a trial. The real work on the trial now begins. The design must be finalised and the appropriate sample size determined; Chapters 4 and 5 cover the key issues with respect to these aspects. Equally important are the practical issues. Even at this stage, a number of people may have been closely involved in formulating the idea for the trial. Many of them will form the embryo 'Trial management group,' who will ultimately be responsible for running the trial. The role and functions of this group are described in Chapters 7 and 8.

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