termsTerm

Futility analysis (stopped for futility)

aka stopped for futility, stopped early for futility, futility boundary, futility analysis, futility stopping, discontinued for futility, terminated for futility, stopped early for efficacy, stopped early, early stopping, stopping boundary, data monitoring committee, DMC, IDMC, DSMB, independent data monitoring committee

A planned check partway through a trial to see whether the new treatment has any realistic chance of proving better; if not, the trial is stopped to spare patients and money. The opposite rule stops a trial early when benefit is overwhelming.

Independent data monitoring committees review unblinded interim data against pre-specified boundaries: futility boundaries (often a conditional power below 10-20%) end trials such as TrilynX (xevinapant) and many phase 3 immunotherapy combinations; efficacy boundaries (O'Brien-Fleming or Lan-DeMets alpha spending) allow early positive readouts, as in KEYNOTE-006 and CheckMate 067. Stopping early for efficacy can overestimate effect size and truncate safety and survival follow-up, while futility stops sacrifice the chance of a late benefit. Sponsors also stop trials for 'business reasons' or poor accrual, which is not the same as futility.

Connected

5top

Pages like this

not linked directly; found by shared links

fronts

Drug Discovery Platforms

terms

Accrual and enrolment Interim analysis, readout and data cut-off Primary, secondary and co-primary endpoints Statistical significance (P values, alpha, multiplicity)