MS Society, Corporate Partners Commit to Diversity in Clinical Trials
The National MS Society, together with a number of its corporate healthcare partners, want to help correct the lack of diversity in clinical trials as part of an effort toward resolving healthcare inequities in the MS community.
To address these disparities, the National MS Society’s Corporate Healthcare Roundtable, a forum including members from the National MS Society and its corporate partners, developed the “Consensus Statement on Health Equity in Clinical Trials and Real-World Evidence Data Collection.”
The statement outlines four core principles to address the lack of diversity for people with multiple sclerosis (MS).
“People with MS need solutions to live their best lives and find a cure. The lack of diversity in clinical trials and the disparity in healthcare delivery are impediments to finding solutions and cures for everyone,” the society said in a press release.
“Inclusivity in clinical trials is critical to better understand what medication is right for each person and achieving the goal of personalized healthcare for all individuals living with MS,” it continued.
Although the importance of clinical trials is widely acknowledged in the MS community, there has been a lack of minority representation when the trials are conducted. In a recent survey, minority participants voiced significant concerns about trial participation.
Underrepresentation can lead to negative consequences, such as unequal access to new therapies and healthcare, which further increases health inequities.
Clinical trials and data collection should be “patient-focused from ideation of clinical trial through real-world evidence data collection,” according to the first principle outlined in the statement.
This means that all patients’ perspectives will be valued and significantly considered when trials, registries, or other methods of data collection are developed.
The statement also includes a commitment to making sure that trials have realistic requirements and appropriately accommodate participants such that “people with MS feel involved, welcomed, and respected from the start.”
To achieve this, the forum is committing to designing trial inclusion/exclusion criteria to help include as diverse a population as possible while maintaining the quality of the study design.
It also intends to consider how social determinants of health, such as literacy, discrimination, economic stability, and healthcare access influence trial recruitment and participation.
To encourage participation across a diverse range of patients, the forum established “effective education that resonates with target audiences,” as one of its principles.
A major focus of this strategy will be to provide educational materials about MS and clinical trials that are multilingual and reflect cultural differences. The principle notes that sensitivity must be shown during the development of the materials about how different groups best receive information and about how trusted sources should be used.
Another strategy will focus on “diversifying outreach and clinical trial sites.” Clinical trial locations are often at clinics where there are MS specialists, however, many MS patients do not live near a specialist, and receive care instead from a general neurologist.
These patients may have significantly restricted access to trial sites.
A greater effort will be made to establish trial sites that are conveniently located for underrepresented participants and to educate general neurologists about clinical trial opportunities for their MS patients, the forum states.
“In conclusion, as members of the MS Corporate Healthcare Roundtable, we support the inclusion of these principles in public policies and commit to practicing these principles as individual organizations and in partnership,” the statement reads.
In addition to the National MS Society, the forum included corporate representatives from Biogen, Bristol Myers Squibb, Genentech, Greenwich Biosciences, Janssen, Optum, Novartis, Sanofi Genzyme, and EMD Serono (known as Merck KGaA outside North America).