A pragmatic clinical trial evaluates whether an intervention works under the conditions of routine clinical practice, with typical patients, clinicians and settings, rather than under the tightly controlled conditions of an explanatory trial.
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| Explanatory | Pragmatic | |
|---|---|---|
| Eligibility | Narrow | Broad |
| Setting | Specialist | Routine care |
| Follow-up | Intensive | Usual care |
| Outcome | Mechanistic | Patient-relevant |
| Question | Can it work? | Does it work? |
In short
Explained
PRECIS-2 helps trial teams make deliberate design choices by rating nine domains from very explanatory to very pragmatic: eligibility, recruitment, setting, organisation, flexibility of delivery, flexibility of adherence, follow-up, primary outcome and primary analysis. A trial can be pragmatic in some domains and explanatory in others; the point is that the choices match the question.
For data collection, pragmatic designs push towards fewer forms, fewer visits and outcomes that can be collected in routine care or directly from participants. ePRO on participants' own phones and simple site forms suit this well, and there is no per-site cost to adding many routine-care sites in Capture. ICH E6(R3) Annex 2, adopted in June 2026, addresses pragmatic elements; see the ICH E6(R3) guide.
Explanatory trials test whether an intervention can work under ideal conditions; pragmatic trials test whether it works in routine practice.
A tool that rates nine trial design domains on a scale from very explanatory to very pragmatic, to help teams align design with the question.
Usually yes, sometimes by cluster (such as practice or hospital) rather than individual participant.
Typically fewer, patient-relevant outcomes, collected with low burden, sometimes from routine records.
No per-site fees, ePRO without apps. Free sandbox.