Timing of randomization and consent

As discussed above, and as a general rule, patients should be randomized as close as possible to the time at which treatment policies diverge, as this minimizes the chance of drop-out before the allocated intervention can be administered. There is, however, another issue concerning the timing of randomization, or more specifically the timing of consent in relation to the timing of randomization. In a conventional trial, the process of randomization consists of assessing a patient's eligibility for a trial, obtaining their consent to be in the trial while explaining that in doing so neither they nor their doctor will know in advance which treatment they will receive, obtaining the randomized allocation, and then informing the patient. Patients are treated and analysed according to their allocated group, as shown in Fig. 4.1.

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