Use of external control arms in immune-mediated inflammatory diseases: a systematic review.

ABSTRACT:

Objectives

External control arms (ECAs) provide useful comparisons in clinical trials when randomised control arms are limited or not feasible. We conducted a systematic review to summarise applications of ECAs in trials of immune-mediated inflammatory diseases (IMIDs).

Design

Systematic review with an appraisal of ECA source quality rated across five domains (data collection, study populations, outcome definitions, reliability and comprehensiveness of the dataset, and other potential limitations) as high, low or unclear quality.

Data sources

Embase, Medline and Cochrane Central Register of Controlled Trial were searched through to 12 September 2023.

Eligibility criteria

Eligible studies were single-arm or randomised controlled trials (RCTs) of inflammatory bow

SUBMITTER: Zayadi A 

PROVIDER: S-EPMC10729249 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature