{"entity":{"id":"pragmatic-trial","kind":"term","name":"Pragmatic trial","aka":["pragmatic trial","pragmatic trials","pragmatic design","pragmatic randomised trial","pragmatic randomized trial","large simple trial","large simple trials","explanatory trial","explanatory versus pragmatic","PRECIS-2","usual care comparator","usual care","real-world trial","point-of-care trial","point-of-care randomisation","embedded trial","broad eligibility","broad eligibility criteria","generalisability","generalizability","external validity"],"tldr":"A pragmatic trial tests a treatment the way it would actually be used: ordinary patients, ordinary clinics, usual care as the comparison and an outcome that matters to patients, so the answer applies in the real world and not only in the trial.","summary":"Trials sit on a spectrum. An explanatory trial asks whether a treatment can work under ideal conditions: narrow eligibility, specialist centres, tightly controlled dosing, a placebo comparator, frequent scans. A pragmatic trial asks whether it does work in practice: broad eligibility including the older and sicker patients who make up most of the clinic, usual care as the comparator, delivery by the usual staff, follow-up through routine records, and an outcome such as survival or hospital admission rather than a scan-defined surrogate. The PRECIS-2 wheel scores a design on nine such dimensions. Pragmatic trials tend to be large, cheap per patient and publicly funded, because the interventions they test (a generic drug, an exercise programme, a screening schedule, a shorter course) rarely have a commercial sponsor.\n\nThe corpus examples are mostly academic. CHALLENGE randomised 889 colon cancer patients after chemotherapy to a coached exercise programme or health-education materials, delivered by physical activity consultants across five countries over three years, and found better disease-free and overall survival; it tested a service, not a molecule. Add-Aspirin randomises 11,000 patients across four cancers in the United Kingdom, Ireland and India to a generic drug or placebo for five years, with publicly funded infrastructure and broad eligibility; it keeps a placebo, so it is pragmatic in scale and setting rather than in every dimension. BWEL delivered a two-year weight-loss programme to more than 3,000 women by telephone. The Indian cluster-randomised screening trials in Kerala, Mumbai and Osmanabad, run through primary health workers in the communities they served, are pragmatic trials at population scale.\n\nThe trade-off is precision for relevance. Usual care varies between sites and drifts over a long trial, adherence is lower than in a tightly run trial, and outcomes drawn from routine records are less complete than trial-collected ones, all of which pull the result towards no difference. A pragmatic trial that shows a benefit is therefore persuasive; one that shows none may have diluted a real effect. Pragmatic and explanatory answers are both needed, in that order for a new drug and often in the reverse order for a change in how care is organised.","asOf":"2026-09-17","wikipedia":"https://en.wikipedia.org/wiki/Pragmatic_clinical_trial","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Pragmatic_clinical_trial"},{"label":"CONSORT statement: reporting randomised trials","url":"https://www.consort-statement.org/"}],"tags":[],"related":["randomised-trial","registry-based-trial","decentralised-trial","cluster-randomised-trial","real-world-evidence","standard-of-care","accrual","trial-failure-modes"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["challenge","add-aspirin","bwel","kerala-oral-screening"],"people":[],"bottlenecks":["b-trial-diversity","b-trial-enrolment","b-real-world-evidence"],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/pragmatic-trial/","neighbours":{"term":[{"id":"accrual","kind":"term","name":"Accrual and enrolment","route":"/terms/accrual/"},{"id":"cluster-randomised-trial","kind":"term","name":"Cluster-randomised trial","route":"/terms/cluster-randomised-trial/"},{"id":"control-arm","kind":"term","name":"Control arm and comparator (investigator's choice)","route":"/terms/control-arm/"},{"id":"decentralised-trial","kind":"term","name":"Decentralised trial","route":"/terms/decentralised-trial/"},{"id":"n-of-1-trial","kind":"term","name":"N-of-1 trial","route":"/terms/n-of-1-trial/"},{"id":"trial-phases","kind":"term","name":"Phase 1, 2 and 3 trials","route":"/terms/trial-phases/"},{"id":"randomised-trial","kind":"term","name":"Randomised trial","route":"/terms/randomised-trial/"},{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"},{"id":"registry-based-trial","kind":"term","name":"Registry-based randomised trial","route":"/terms/registry-based-trial/"},{"id":"seamless-adaptive","kind":"term","name":"Seamless, adaptive and Bayesian trial designs","route":"/terms/seamless-adaptive/"},{"id":"standard-of-care","kind":"term","name":"Standard of care","route":"/terms/standard-of-care/"},{"id":"stepped-wedge-design","kind":"term","name":"Stepped-wedge design","route":"/terms/stepped-wedge-design/"},{"id":"trial-failure-modes","kind":"term","name":"Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover","route":"/terms/trial-failure-modes/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"trial":[{"id":"add-aspirin","kind":"trial","name":"Add-Aspirin","route":"/trials/add-aspirin/"},{"id":"bwel","kind":"trial","name":"BWEL (Breast Cancer Weight Loss, Alliance A011401)","route":"/trials/bwel/"},{"id":"challenge","kind":"trial","name":"CHALLENGE (CCTG CO.21)","route":"/trials/challenge/"},{"id":"kerala-oral-screening","kind":"trial","name":"Kerala oral cancer visual screening trial (Trivandrum)","route":"/trials/kerala-oral-screening/"}],"bottleneck":[{"id":"b-trial-diversity","kind":"bottleneck","name":"Trials do not represent the people who get cancer","route":"/bottlenecks/b-trial-diversity/"},{"id":"b-trial-enrolment","kind":"bottleneck","name":"Trials enrol too few, too slowly","route":"/bottlenecks/b-trial-enrolment/"},{"id":"b-real-world-evidence","kind":"bottleneck","name":"Weak real-world evidence and registries","route":"/bottlenecks/b-real-world-evidence/"}]}}