When randomisation goes horribly wrong: examples of major failures of randomisation and strategies to avoid them.

ABSTRACT:

Background

Randomisation forms the foundation of clinical trials, but its implementation can be prone to error. Often randomisation errors affect few participants and do not seriously compromise the integrity of the trial. However, in some cases randomisation errors can have widespread consequences and call into question the validity of trial conclusions. Published articles may be retracted as a result. Valuable insight can be gained from studying past errors to minimise the risk of similar errors and their disastrous consequences impacting future trials. The aims of this article are to (i) describe examples of major failures of randomisation, and (ii) provide guidance on how to avoid them in practice.

Methods

Major failures of randomisation were defined as inadvertent error

SUBMITTER: Yelland LN 

PROVIDER: S-EPMC12837040 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature