Takeaways from the ACTRIMS Forum 2023

Strategies for Improving Inclusivity and Patient-Centricity in MS Clinical Trials

Jowita Marszewska, Ph.D. – Scientific Advisor at Clario

“MS: Going Viral,” was the theme for this year’s ACTRIMS Forum, selected to highlight new discoveries about the role of viruses in Multiple Sclerosis (MS) onset and disease management.

The 8th annual Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023 took place between 23-25 February in San Diego, California. The focus of this Forum is to highlight innovation in MS research and clinical care.

One such item is the quality of life (QOL) assessment patient-reported outcome (PRO) describing how a patient feels, functions or survives during a treatment. Information provided by a patient helps make a determination of MS disease stage and progression and helps reach a conclusion of a treatment benefit in the clinical trial space. Clario’s research poster presented by eCOA scientist Jowita Marszewska, PhD was focused on QOL assessments in MS trials, specifically, time needed by participants to complete QOL assessments on electronic devices. Diseases such as MS might impair a patient’s functioning, which is why the completion time should be considered when selecting the right instrument(s) for data collection.

The Importance of Quality of Life Assessments in Clinical Trials

Selection of the right QOL instrument is an essential step to collect the right data to be able to demonstrate a treatment benefit. This is where Clario can help. Our deep experience in the science surrounding developing trial protocols and data collection and regulatory expertise means we can help tailor the trial to the specifics of the patient and the condition, reducing patient burden and improving engagement. Our solutions are patient-centric and deliver high-quality data, whether collected remotely or at a site visit.

Strategies for Improving Inclusivity and Patient-Centricity in MS Clinical Trials

Other valuable aspects of MS clinical design were presented, e.g., Leorah Freeman, MD, PhD voiced that sponsors and institutions, trial designers, investigators and patients share a responsibility to bring inclusivity into clinical trials. Some of the strategies for trial design include deploying decentralized or hybrid trials and addressing patient burden. The Barancik Prize for innovation in MS research winner – Ruth Ann Marrie, MD, PhD – mentioned that quality of life is a clinically meaningful outcome for patients with MS and should be included not only in clinical trials but also in clinical care. Suggestions made by both of these speakers aligned with the message conveyed by
Clario’s poster.

MS disease and new research updates

MS is an incurable disease of the central nervous system (CNS). Risk factors for developing MS include smoking tobacco, vitamin D deficiency, genetic predispositions and biological sex but more importantly, it’s recently been demonstrated that that the Epstein-Barr virus (EBV) causes MS.^1,2 The linkage between these risk factors and EBV was really brought to light during the Kenneth P. Johnson Memorial lecture, where Lawrence Steinman, MD shared that 95-99% of adult US population has been infected with EBV, but only some individuals develop MS. He also posed interesting questions: is it possible to eliminate MS by vaccinating children for EBV and will eliminating EBV have any negative implications? These questions may be answered in the long run; the first clinical trial of the EBV vaccine has just been launched last year.

For any questions regarding the quality of life research, please contact [email protected]

Written by

Jowita Marszewska, Ph.D.

Scientific Advisor at Clario

References

• Bjornevik K, Cortese M, Healy BC, et al. Longitudinal analysis reveals high prevalence of Epstein-Barr virus associated with multiple sclerosis. Science. 2022;375(6578):296-301. doi:10.1126/science.abj8222
• Robinson WH, Steinman L. Epstein-Barr virus and multiple sclerosis. Science. 2022;375(6578):264-265. doi:10.1126/science.abm7930