{"entity":{"id":"interim-analysis","kind":"term","name":"Interim analysis, readout and data cut-off","aka":["interim analysis","interim analyses","first interim analysis","second interim analysis","prespecified interim","final analysis","final OS analysis","primary analysis","data cut-off","data cutoff","data cut","readout","read out","reads out","topline","top-line","topline results","top-line data","headline results","updated analysis","long-term follow-up","extended follow-up","5-year update","results expected","data expected"],"tldr":"A trial's results are not one event but a series: pre-planned looks at the data (interim analyses) while it is still running, a data cut-off date that freezes the dataset for each look, a 'topline' announcement of the headline numbers, and a final analysis when enough events have happened.","summary":"Time-to-event trials are 'event-driven': analyses occur after a set number of progressions or deaths, so timing depends on how fast events accrue, and companies announce 'readouts' when those milestones arrive. Interim analyses use alpha-spending so that repeated looks do not inflate false positives; a positive interim for progression-free survival often comes years before the final overall survival analysis. Topline press releases precede peer-reviewed publication by months and may omit key details, which is why the site distinguishes press-release from published evidence. The data cut-off, not the publication date, is the date the numbers describe.","asOf":"2026-09-09","wikipedia":"https://en.wikipedia.org/wiki/Interim_analysis","links":[{"label":"Wikipedia","url":"https://en.wikipedia.org/wiki/Interim_analysis"}],"tags":[],"related":["futility","primary-endpoint","data-maturity","statistical-significance","group-sequential-design","data-monitoring-committee","sample-size-re-estimation","trial-lifecycle"],"cancers":[],"sections":["drug-discovery"],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":["adaura","trilynx"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"category":"Trials"},"route":"/terms/interim-analysis/","neighbours":{"term":[{"id":"data-maturity","kind":"term","name":"Data maturity (immature vs mature survival data)","route":"/terms/data-maturity/"},{"id":"data-monitoring-committee","kind":"term","name":"Data monitoring committee (DSMB, IDMC)","route":"/terms/data-monitoring-committee/"},{"id":"futility","kind":"term","name":"Futility analysis (stopped for futility)","route":"/terms/futility/"},{"id":"group-sequential-design","kind":"term","name":"Group sequential design, stopping rules and alpha spending","route":"/terms/group-sequential-design/"},{"id":"landmark-survival","kind":"term","name":"Landmark and milestone survival (5-year survival, median follow-up)","route":"/terms/landmark-survival/"},{"id":"master-protocol","kind":"term","name":"Master protocol (platform, basket and umbrella trials)","route":"/terms/master-protocol/"},{"id":"primary-endpoint","kind":"term","name":"Primary, secondary and co-primary endpoints","route":"/terms/primary-endpoint/"},{"id":"seamless-adaptive","kind":"term","name":"Seamless, adaptive and Bayesian trial designs","route":"/terms/seamless-adaptive/"},{"id":"sample-size-re-estimation","kind":"term","name":"Statistical power, sample size and re-estimation","route":"/terms/sample-size-re-estimation/"},{"id":"statistical-significance","kind":"term","name":"Statistical significance (P values, alpha, multiplicity)","route":"/terms/statistical-significance/"},{"id":"trial-lifecycle","kind":"term","name":"Trial lifecycle: from protocol to label","route":"/terms/trial-lifecycle/"}],"section":[{"id":"drug-discovery","kind":"section","name":"Drug Discovery Platforms","route":"/fronts/drug-discovery/"}],"trial":[{"id":"adaura","kind":"trial","name":"ADAURA","route":"/trials/adaura/"},{"id":"focus4","kind":"trial","name":"FOCUS4","route":"/trials/focus4/"},{"id":"gbm-agile","kind":"trial","name":"GBM AGILE","route":"/trials/gbm-agile/"},{"id":"precision-promise","kind":"trial","name":"Precision Promise","route":"/trials/precision-promise/"},{"id":"stampede","kind":"trial","name":"STAMPEDE","route":"/trials/stampede/"},{"id":"trilynx","kind":"trial","name":"TrilynX","route":"/trials/trilynx/"}],"journal":[{"id":"leukemia","kind":"journal","name":"Leukemia","route":"/journals/leukemia/"}]}}