termsTerm

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

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.

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.

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Data maturity (immature vs mature survival data)Futility analysis (stopped for futility)Landmark and milestone survival (5-year survival, median follow-up)Primary, secondary and co-primary endpoints Seamless, adaptive and Bayesian trial designs Statistical significance (P values, alpha, multiplicity)