Multicentre trial

Multicenter clinical trial (multicenter study) – a clinical trial conducted at multiple research sites simultaneously under the same study protocol, where study subjects are recruited and enrolled at several different institutions rather than just one site.

Definitions

ICH E6(R2)

1.40 Multicentre Trial:

A clinical trial conducted according to a single protocol but at more than one site, and therefore, carried out by more than one investigator .

Features of multicenter studies

Multicenter studies conducted using the same protocol, same informed consent documents, and same regulatory approval. Multicenter trials offer several advantages, including:

• improved recruitment and enrollment rate,
• increased participant diversity, and
• enhanced generalizability.

However, conducting multicenter trials also presents project management challenges, including the:

• coordinating activities among multiple sites,
• ensuring consistent adherence to study protocol, and
• managing data collection across different locations.

See also