Marking CMV Awareness Month in June
Cytomegalovirus (CMV) is a latent virus, meaning that once it infects a person’s body, it stays there for life and can reactivate.¹ More than half of U.S. adults over the age of 40 have been infected at some point in their lives,¹ but pregnant women can unknowingly pass the infection to their unborn babies, which can cause long-term health problems.¹ It is the most common infectious cause of birth defects in the U.S.¹
The impact of CMV is uneven across different racial and ethnic groups, significantly affecting diverse communities. For instance, the rate of congenital CMV infection is significantly higher in Black infants as compared to other populations.² This disparity highlights the importance of ensuring that our clinical trials reflect the diverse communities we serve, so that people of all backgrounds have access to the promising medicines of tomorrow.
This starts with the earliest phase of making those medicines – research. We remain committed to ensuring a diverse range of participants in our clinical trials, including in our pivotal Phase 3 trial for CMV, CMVictory, which is fully enrolled. Our demographic objectives for the CMVictory trial included that 42% of participants in the United States are People Of Color.³
We also continue to focus on removing unnecessary logistical barriers to participation. For example, one major barrier to conducting inclusive clinical trials has been access to information about the clinical trials themselves. In fact, a report from the U.S. Food and Drug Administration (FDA) found that there is a significant imbalance in representation of minorities in clinical research. Whites make up 67% of the U.S. population, but are 83% of research participants, and Black/African Americans make up 13.4% of the U.S. population, but only 5% of trial participants.⁴ Throughout enrollment, we partnered with retail pharmacies and community health organizations in a variety of capacities to build awareness of the value of scientific research and our CMVictory trial, including through educational materials, informed consent forms and trial support tools in native languages. We also sent mobile units into more remote communities and medically underserved neighborhoods that simultaneously offer access to basic health checkups while giving people an opportunity to learn more about potential participation in our clinical trials.
Additional challenges for enrolling in clinical trials also include the time commitment to completing clinical trial activities and taking time off work. Since everyone’s life and schedule looks different, we committed to offering flexible clinical trial visit options. Where appropriate, safe, and in line with regulatory standards, participants could choose between home visits, telemedicine or reimbursements for out-of-pocket expenses related to the clinical trial. We have found that incorporating flexible visit schedules has been instrumental in boosting our enrollment and retention rate, including a 93% retention rate across our clinical trials.
By building strong partnerships and meeting people where they are, we can dramatically increase participation from medically underserved communities and diverse populations. As we continue to advance our mission to deliver the greatest possible impact to people through mRNA medicines, we will continue acting as an industry leader with the innovative approaches we are taking to increase the inclusiveness of our scientific research.
¹https://www.cdc.gov/cytomegalovirus/about/index.html
²Lantos PM, Permar SR, Hoffman K, Swamy GK. The Excess Burden of Cytomegalovirus in African American Communities: A Geospatial Analysis. Open Forum Infect Dis. 2015 Nov 20;2(4):ofv180. doi: 10.1093/ofid/ofv180. PMID: 26716106; PMCID: PMC4691661
³https://assets.modernatx.com/m/5cc10007e5a806e6/original/Moderna_ESG_2022.pdf
⁴https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-research/