# Futility analysis (stopped for futility)

Source: https://onco.cc/terms/futility/  
OnCo record `futility` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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 a string of 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.

## Fields

- Kind: Term
- Last checked: 2026-09-09
- Also known as: 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; futility boundaries

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Interim_analysis
- Wikipedia: https://en.wikipedia.org/wiki/Interim_analysis

## Connected records

- terms: [Accrual and enrolment](https://onco.cc/terms/accrual/), [Data monitoring committee (DSMB, IDMC)](https://onco.cc/terms/data-monitoring-committee/), [Group sequential design, stopping rules and alpha spending](https://onco.cc/terms/group-sequential-design/), [Interim analysis, readout and data cut-off](https://onco.cc/terms/interim-analysis/), [Primary, secondary and co-primary endpoints](https://onco.cc/terms/primary-endpoint/), [Response-adaptive randomisation](https://onco.cc/terms/response-adaptive-randomisation/), [Statistical power, sample size and re-estimation](https://onco.cc/terms/sample-size-re-estimation/), [Statistical significance (P values, alpha, multiplicity)](https://onco.cc/terms/statistical-significance/), [Why trials fail: underpowered, wrong endpoint, control arm drift, subgroup fishing, crossover](https://onco.cc/terms/trial-failure-modes/)
- fronts: [Drug Discovery Platforms](https://onco.cc/fronts/drug-discovery/)
- trials: [DREAM3R](https://onco.cc/trials/dream3r/), [Ivermectin plus losartan for COVID-19 in cancer patients (ICESP phase 2, terminated)](https://onco.cc/trials/nct04447235/), [JAVELIN Head and Neck 100](https://onco.cc/trials/javelin-hn-100/), [MAGNITUDE](https://onco.cc/trials/magnitude/), [TrilynX](https://onco.cc/trials/trilynx/)

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