Pragmatic Trial
A trial designed to evaluate effectiveness in usual-care settings, using broad eligibility, routine workflows, and outcomes meaningful to patients and payers.
Definition
A pragmatic clinical trial is designed to evaluate effectiveness in everyday clinical practice rather than the controlled efficacy demonstrated in tightly designed explanatory trials. Pragmatic trials use broad eligibility, real-world clinical settings, flexible interventions delivered by routine providers, and patient-centered or claims-derived outcomes. The PRECIS-2 framework helps trial designers position a study along the explanatory-pragmatic continuum across nine domains.What this means in practice
Pragmatic trials are central to value-based care evidence generation and to MedTech post-market studies that support broader reimbursement.- •Confusing pragmatic with low-rigor, pragmatic trials still require pre-specified analysis and unbiased outcome ascertainment.
- •Choosing claims data for outcomes without understanding coding lag and accuracy.
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsInternational standard for the design, conduct, and reporting of clinical trials.
Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data.
Payment tied to outcomes and total cost of care, not volume of services.
More in Clinical & Trials
· Same categoryTrial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data.
Any untoward medical occurrence in a subject, whether or not related to the device.
Data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate (plus Complete, Consistent, Enduring, Available).
An IVD's ability to detect small quantities of an analyte.
Primary references
3 sources- 1
NIH Pragmatic Trials CollaboratoryVerifiedNIHrethinkingclinicaltrials.org
- 2
PRECIS-2VerifiedPRECIS-2precis-2.org
- 3
FDA - Clinical Trials and Human Subject ProtectionVerifiedFDAfda.gov
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