Читать книгу Randomised Clinical Trials - David Machin - Страница 101

There are two aspects of the randomisation process that need to be described in the protocol. One is the structural features of the design while the other is the more procedural aspects of how patients will be randomised and hence allocated to a specific intervention. However, as we will discuss in Chapter 5, there is a difficulty in that if full details of a block based or other restricted randomisation schemes are made explicit in the protocol itself then the objectivity of the randomisation process may be compromised. So, we advise that such details are held in a confidential memo by the statistical team which is securely stored in the trial office files and, if need be, shared with the approving authorities but not with the clinical members of the protocol team until trial recruitment is complete.