Data & Quality
Interim Analysis
An interim analysis is a pre-planned statistical evaluation of accumulating clinical trial data while the trial is ongoing, used to assess efficacy, futility, safety, or to trigger sample-size adaptation.
Interim analyses are performed by an independent Data Monitoring Committee (DMC) and governed by group-sequential or alpha-spending methods (O'Brien-Fleming, Pocock, Lan-DeMets) to control the overall Type 1 error rate.
Common interim decisions include early stopping for overwhelming efficacy, stopping for futility, dropping inferior arms in a platform trial, or adjusting sample size based on observed variance.
Related terms
Data Monitoring Committee (DMC)
A Data Monitoring Committee (DMC), also called a Data and Safety Monitoring Board (DSMB), is an independent group of experts that periodically reviews accumulating trial data to safeguard participant safety, study integrity, and scientific validity.
Adaptive Trial Design
An adaptive trial design is a clinical trial that uses pre-specified rules to modify aspects of the study (sample size, randomization ratio, dose, treatment arms, endpoints) based on accumulating interim data, without compromising scientific validity.
Statistical Analysis Plan (SAP)
A Statistical Analysis Plan (SAP) is a detailed technical document that specifies, before database lock, every statistical analysis to be performed on a clinical trial's data, including primary and secondary endpoint analyses, handling of missing data, multiplicity adjustments, and sensitivity analyses.
See how Kitsa applies this in your trials
Kitsa's agentic AI compresses protocol development, site selection, and patient pre-screening from months into weeks.
Request a demo