Safety reporting quality in multiple sclerosis clinical trials: A review of phase III clinical trials included in FDA approval of disease-modifying treatments.

ABSTRACT:

Background

Evaluating safety of emerging interventions is important in clinical trials. To support reporting of safety outcomes, a harms extension of the Consolidated Standards of Reporting Trial (CONSORT) guidelines was published in 2004.

Objective

To examine safety reporting in pivotal trials of disease-modifying therapies (DMTs) in patients with multiple sclerosis (MS).

Methods

Published phase III clinical trials from 1995 to 2022 included in FDA approval material for MS DMTs were compiled and reviewed by two independent examiners. Criteria derived from the CONSORT harms extension were used to evaluate safety reporting. Linear regression was applied to examine associations between quality of safety reporting and study level factors.

Results

30 publications w

SUBMITTER: Lin WZ 

PROVIDER: S-EPMC12576269 | biostudies-literature | 2025 Oct-Dec

REPOSITORIES: biostudies-literature