Potential Benefits and Risks of Interim Analyses in Clinical Studies.

Abstract

Interim analyses are statistical evaluations of data collected during an ongoing study. These analyses can provide early evidence of the effectiveness and safety of an intervention, allowing investigators to make informed decisions about whether to continue the trial or revise the study design to optimize the trial outcomes. When used judiciously, interim analyses offer potential benefits such as resource and time savings, expedited treatment development, and protecting patients from ineffective or unsafe interventions.