Design, Conduct, and Analysis of Externally Controlled Trials.

ABSTRACT:

Importance

Externally controlled trials (ECTs) can serve as an alternative in settings where randomized clinical trials (RCTs) are unfeasible. However, the methodological rigor of ECTs, particularly with regard to bias control, is often inadequately assessed, which can compromise the validity of studies and lead to incorrect decisions.

Objective

To examine the design, conduct, and analysis characteristics of current ECTs and to assess whether appropriate methods were used to control bias.

Design, setting, and participants

This cross-sectional study searched PubMed for ECTs published between January 1, 2010, and December 31, 2023. Eligible ECTs included single-arm trials with an external control or that used a treatment group from an RCT compared with an external contr

SUBMITTER: Liu J 

PROVIDER: S-EPMC12411980 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature