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3.10.3 Interim analysis

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As part of the monitoring of the progress of trials, while recruitment is still ongoing, many protocols include interim looks at the trial data and these may be reviewed by an independent Data and Safety Monitoring Board (DSMB) more details of which are given in Chapter 10. One example of the remit given to a DSMB is in Example 3.22, which is taken from the EXPEL (2016) protocol as described by Kim, Chen, Tay, et al. (2017).

Randomised Clinical Trials

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