The global head of medical affairs-neurology at Janssen Pharmaceutical provided background on the need for real-world studies and how they can accurately portray a disease community.
"Especially for symptoms that can be somewhat ‘invisible,’ like fatigue, real-world data is important because it allows you to use the power of patient insights.”
Oftentimes, the inclusion criteria for clinical trials can be lengthy to some extent and may be more tailored towards a homogenous patient population that, in the researcher’s eyes, represent the greater disease population as a whole. While there is thorough detail to creating these trials, the results may end up not being as applicable as once thought.
That raises the importance of conducting real-world studies, which pool a larger number of patients that represent the everyday human and are thus not confined to as strict of criteria. A recently published real-world study of patients in the US that was presented at Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2021, February 25-27, aimed to measure the impacts of fatigue in adults with MS. Researchers utilized a novel disease specific scale called the Fatigue Symptoms and Impacts Questionnaire-Relapsing Multiple Sclerosis (FSIQ-RMS) and found that fatigue was rated as severe with a mean score of 57.3 among a cohort of 300 patients with relapsing MS (RMS).
Allitia DiBernardo, MD, global head of medical affairs, neurology, Janssen Pharmaceutical, took the time to discuss the real-world study with NeurologyLive, and offered what the benefits are in conducting them.
For more coverage of ACTRIMS 2021 Forum, click here.