Introduction

In this chapter, we consider all that needs to be done up to the launch of a trial. We describe the functions and roles that the team responsible for conducting the trial needs to fulfill, a team we denote generically as the trial management group.

Some trials will be planned and conducted by an individual person, others as part of a programme of multi-centre randomized trials by an established trials office. Setting up and conducting a single trial or a programme of trials is, however, a major and specialized activity which should only be undertaken by persons or groups with the necessary expertise and experience, whether or not they constitute an established longstanding group. Individuals conducting the trial should include, or have access to, the necessary statistical, medical, computing and data management expertise. Such expertise is essential and can be provided in a number of ways through the course of the trial. It is important to recognize, however, the need for continuity of personnel and for the non-clinical staff to be conversant with the medical issues. The same expertise should also be available to those running small trials or phase II studies within a single centre. Expert advice on such matters as histopathology, quality of life assessment, and health economics, may also be required.

It is essential that those involved in setting up and conducting trials are experts in their own specialized areas and keep up-to-date on all aspects of their work, including progress in the treatment of the cancers with which they deal and developments in trials methodology and computing software. This could involve attending appropriate training courses, providing in-house training, including relevant higher degrees and diplomas, and participating in specialist conferences and clinical and scientific meetings. The trial coordinators must assign sufficient time and funding to training.

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