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As we have illustrated, the size of clinical trials can range from the relatively few to as many as several thousands of subjects being recruited. Consequently, and leaving specific details aside, these will require a range of resources from the relatively modest to the very considerable. It must be emphasised that the size of a clinical trial is determined by the question(s) that are posed, and the resources allocated should reflect the importance of that question. Clearly, a very experienced team is required to launch a large trial but even the design team of an ultimately small sized trial will need access to appropriate personnel including, at a minimum, those with clinical, statistical, data management and organisational skills and often other specialist skills from, for example, pharmacy, pathology and many other specialties. It is important that the design team do not underestimate the scale of the task.

The focus of this book is on the design of (randomised) comparative (usually termed Phase III) trials which are likely to be of relatively modest size. We aim to give clear guidance as to how these may be designed, conducted, (to some extent) analysed and reported. However, it is also important that investigators contributing patients to clinical trials who are perhaps not part of the design team also understand the issues concerned as the very success of the trials depends crucially on their collaboration and understanding of the processes involved.