{"entity":{"id":"idea-data-registry-based-rcts","kind":"idea","name":"Registry-based randomised trials for oncology comparative effectiveness","aka":[],"tldr":"Use the cancer registry itself as the trial machine: randomise patients at diagnosis, then let the registry collect the outcomes for a fraction of the usual cost.","summary":"Registry-based randomised trials (R-RCTs), pioneered in Swedish cardiology, use the registry for identification, randomisation and outcome follow-up. Oncology has the registries (Nordic, England, Netherlands) but almost no R-RCTs. The proposal funds a programme of five R-RCTs on high-value comparative questions with routine endpoints (surveillance intervals, adjuvant duration, supportive care) and develops the ethics and consent templates to make the design routine.","asOf":"2026-09-08","links":[{"label":"Bottleneck evidence (Weak real-world evidence and registries): Gyawali, Hey & Kesselheim, Assessment of the clinical benefit of cancer drugs receiving accelerated approval (JAMA Intern Med 2019)","url":"https://doi.org/10.1001/jamainternmed.2019.0462"}],"tags":[],"related":[],"cancers":[],"sections":["ai-computation"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["karolinska"],"pathways":[],"terms":["real-world-evidence"],"trials":[],"people":[],"bottlenecks":["b-real-world-evidence","b-trial-design","b-trial-enrolment"],"keyPapers":["paper-gyawali-jama-intern-med"],"journals":[],"dependsOn":[],"notes":[],"hypothesis":"R-RCTs will answer comparative effectiveness questions with 2,000 or more patients at under 500 dollars per patient and within three years, roughly a tenth of conventional trial cost.","rationale":"TASTE randomised 7,244 patients for a small fraction of a conventional trial budget; oncology questions about duration, schedule and surveillance have equally routine endpoints.","test":"Run one R-RCT in a Nordic or English registry (for example, imaging surveillance every six versus twelve months after curative colorectal surgery) and report cost, enrolment and completeness of outcomes.","maturity":"early-clinical","actor":"research","cost":"medium","horizonYears":4},"route":"/ideas/idea-data-registry-based-rcts/","neighbours":{"section":[{"id":"ai-computation","kind":"section","name":"AI & Computation","route":"/fronts/ai-computation/"}],"institution":[{"id":"karolinska","kind":"institution","name":"Karolinska University Hospital","route":"/institutions/karolinska/"}],"term":[{"id":"real-world-evidence","kind":"term","name":"Real-world evidence","route":"/terms/real-world-evidence/"}],"bottleneck":[{"id":"b-trial-design","kind":"bottleneck","name":"Trial design, endpoints and cost","route":"/bottlenecks/b-trial-design/"},{"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/"}],"paper":[{"id":"paper-gyawali-jama-intern-med","kind":"paper","name":"Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval","route":"/key-papers/paper-gyawali-jama-intern-med/"}]}}