Observational data: Understanding the real MS world

Abstract

Randomised clinical trials are the primary source of evidence, guiding the use of disease-modifying drugs in multiple sclerosis. However, the spectrum of questions that can be answered in the trial setting is relatively narrow. 'Real-world' observational data analysis has always been the major source of evidence for epidemiology, aetiology, outcomes and prognostics, but is now also increasingly used to study treatment effectiveness. While analyses of observational cohorts typically offer superior power, generalisability and duration of follow-up relative to prospective randomised trials, they are also subject to multiple biases. It is the role of researchers to mitigate bias and to ensure th..