How can a 15 thousand-patient randomised study be conducted at a low cost? By the old method “you just have to wait for the patients to turn up”. A lot of the work is done to find the patients. Baigent explains that a pragmatic trial is streamlined e.g. through the utilization of existing networks to recruit patients, in this case PCORnet, and collection of data through electronic health records.
Can trials for approval of a new drug ever be pragmatic? And why is the uptake of pragmatic trials slow?