PCORI considers placebo to be a reasonable comparator if active treatments/interventions/screenings are not available, or if there is a compelling reason why active treatments/interventions/screenings cannot be included in the study design. Usual care can also be a reasonable comparator, provided that rationale for its use as a comparator is persuasive.
How does PCORI define “comparative” (placebo, usual care)? In behavioral health interventions and in prevention research, the concern is that studies comparing process variables may not meet PCORI’s definition of comparative.
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