Skip to content
My Glossary Project

Interim Analyses

TL;DR

Section titled “TL;DR”
  • Conducted during a clinical trial at preplanned or regular intervals to monitor progress.
  • Used to assess safety and efficacy and to decide whether to stop, continue, or modify the trial.
  • Typical timing examples include every six months or every 100 patients.

Definition

Section titled “Definition”

Interim analyses are periodic evaluations of data that are conducted during a clinical trial. These analyses are used to assess the safety and efficacy of a treatment being studied, as well as to make any necessary adjustments to the trial design.

Explanation

Section titled “Explanation”

Interim analyses can be performed at any point during a clinical trial but are typically conducted at regular intervals, such as every six months or every 100 patients. They serve to evaluate whether the treatment causes adverse effects (safety) and whether it produces the desired clinical effect (efficacy). Based on these evaluations, investigators may stop the trial early to prevent harm, stop early for demonstrated efficacy, continue as planned, or modify the treatment regimen or other aspects of the trial design.

Examples

Section titled “Examples”

Safety assessment

Section titled “Safety assessment”

An interim analysis can assess whether the treatment is causing any adverse effects in trial participants. If the treatment is found to be unsafe, the trial may be stopped early to prevent further harm.

Efficacy assessment

Section titled “Efficacy assessment”

An interim analysis can assess whether the treatment is having the desired effect on participants. If the treatment is effective, the trial may continue as planned; if not, the trial may be stopped early or the treatment regimen may be modified.

Use cases

Section titled “Use cases”
  • Real-time monitoring of a clinical trial to allow timely adjustments.
  • Ensuring participant safety by detecting harmful effects early.
  • Helping maximize the chances of success for the treatment being studied by identifying efficacy signals or the need for modifications.

Notes or pitfalls

Section titled “Notes or pitfalls”
  • Interim analyses can lead to stopping a trial early for safety concerns or for demonstrated efficacy.
  • Interim analyses can also prompt modification of the treatment regimen or other trial design elements if the treatment is not producing the desired effect.
Section titled “Related terms”
  • Clinical trial
  • Safety
  • Efficacy
  • Treatment regimen