Regional variation in clinical-trial risks: a large-scale analysis of 585 clinical trials.

ABSTRACT:

Objectives

To assess 10 common indicators of clinical trial risks across regions.

Design

Retrospective pooled analysis of routine central-monitoring outputs.

Data sources

Data came from a central-monitoring platform (2015-2025), which contains data from clinical trials conducted worldwide by 46 different sponsors and contract research organisations acting on behalf of sponsors. Trial sites were grouped into seven geographic regions-North America, Central/South America, Western Europe, Eastern Europe, Africa/Middle East, Asia, Pacific-to assess regional differences in monitored clinical-trial risks.

Main outcome measures

Primary outcome-Relative Key Risk Indicator (KRI) risk score, defined as the relative risk in the selected region in comparison to the expected

SUBMITTER: de Viron S 

PROVIDER: S-EPMC12551543 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature