Clinical trials with interim analyses: Standardizing Terminology to increase clarity

TL;DR

This paper advocates for standardized terminology in clinical trial interim analyses to improve clarity and reduce misunderstandings among stakeholders, drawing on a multi-stakeholder perspective.

Contribution

It introduces a standardized terminology for interim analyses in clinical trials to enhance communication and understanding across diverse stakeholders.

Findings

Standardized terminology reduces confusion in clinical trial discussions.

Multi-stakeholder perspectives highlight key concepts and common misunderstandings.

Clearer terminology facilitates better decision-making in interim analyses.

Abstract

Interim analyses for group-sequential decision making are prevalent in clinical trials. Methodology is well established and has been routinely implemented over the last decades. Still, confusions and uncertainties on aspects of how to operationalize and interpret interim analyses exist for many stakeholders. In this paper, a team of statisticians from the pharmaceutical industry, academia, and regulatory agencies provide a multi-stakeholder perspective on the key concepts behind interim analyses, with the aim to introduce standard terminology to mitigate misunderstandings and facilitate clearer discussions.