How is a patient randomised for a particular trial?

For each patient who might be considered suitable for inclusion in a clinical trial, the following sequence of events should take place:

• patient diagnosed for treatment;
• patient defined as eligible for inclusion in trial (according to Protocol);
• clinician is willing to accept randomisation;
• patient consent (or that of parent) is obtained;
• patient formally entered on trial;
• treatment assignment obtained from randomisation list (prepared by independent statistician and generated by computer);
• on study forms are completed;
• treatment commences.

Patient registration and randomisation must be achieved promptly so that there is no delay in the commencement of treatment.

>>>> What is a control in clinical trials? >>>>