[Generalisability of Phase III Clinical Trials Using the Example of Two German Multiple Sclerosis Registries].

ABSTRACT: Newly approved therapies usually have unknown adverse events, although the clinical trials that led to approval had already tested them for safety and efficacy. One reason for this is that the inclusion and exclusion criteria of the trials often do not fully reflect the usually heterogeneous patient population in routine clinical care.The aim of the study was to analyse the extent to which patients with multiple sclerosis (MS) in routine clinical care fulfil the inclusion and exclusion criteria for the corresponding clinical phase III trial of the respective drug.Sociodemographic and clinical characteristics as well as (serious) adverse events ((S) AEs) were compared. Data were based on two national, prospective, observational, clinical, multicentre registries, the REGIMS registry and the

SUBMITTER: Jalusic KO 

PROVIDER: S-EPMC12674891 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature