Diseases Don’t Discriminate—Neither Should Clinical Research
Yesterday we hosted Moderna’s annual Vaccines Day during which we announced two important clinical milestones in our prophylactic vaccines core modality: new positive interim Phase 1 data from our Respiratory Syncytial Virus (RSV) vaccine candidate and new 7-month interim Phase 2 data from our cytomegalovirus (CMV) vaccine candidate.
Additionally, building on our COVID-19 vaccine clinical development experience, we underscored our plan to invest resources and continue to leverage the power of our mRNA platform to accelerate the development of our mRNA vaccine pipeline. It is truly an exciting time to be at Moderna!
As part of our Vaccines Day agenda, I had the honor of presenting on the topic of Diversity & Inclusion in clinical trials. I shared how we’re building our capabilities at Moderna and how we’re applying what we learned from our COVID-19 trial experience to our upcoming CMV Phase 3 study. For those who are curious, I will share a few key highlights from my presentation as well as some reflections here today.
How did we get here?
2020 was an unexpected year for all of us. The world looked to industry to run clinical trials for vaccines against COVID-19 as quickly and safely as possible. With our partners, Moderna enrolled more than 31,000 participants in our COVID-19 vaccine trials, and our Phase 3 COVE study was conducted in more than 100 locations across the U.S. However, speed and quality were not the only considerations for our vaccine program.
As we are all aware, COVID-19 has a disproportionate impact on racial and ethnic minority communities. It was our goal to design a trial for everyone. We were so committed to diversity and inclusion in our COVE study that we slowed enrollment to ensure representation. In the end, our trial included more than 11,000 participants from communities of color, representing 37 percent of the study population.
The population of our COVE study was similar to the diversity of the U.S. at large and representative of the U.S. population at risk for COVID-19 infection. This was a tremendous outcome when you consider that historically 94 percent of all clinical trial participants in America were Caucasian.¹
What did we know and learn?
The primary goal of diversity in clinical research is to understand the influence of biology, environment and lifestyle in treatment response. Diversity exists across many dimensions and is context-specific. We knew the importance of each factor, such as race, sex, age and co-morbidities—and that they may vary depending upon the disease or condition and the population at risk.
Additionally, we understood that achieving diversity in clinical trials poses even more scientific complexity and practical barriers. In our COVE study, it was critical that we took into account barriers including mistrust, limited of awareness of trials, time and resource constraints, lack of information or language/literacy barriers, and conflicts with one’s ethnic and cultural beliefs, to name a few.
We determined that it is essential to build trust in our communities, starting with Primary Investigators and trial sites. We can reduce barriers by giving investigators the tools and providing the educational materials as a means to help build trust, which takes time. By helping investigators build local relationships in their communities, they can in turn address barriers and reduce burden.
Our experience was humbling and reinforced that no one can do this alone. In addition to partnering with trial sites, we partnered with trusted community organizations and experts to help assure trial access was extended into minority neighborhoods.
We also convened neighborhood members to build an advisory board with faith based and community groups. Bringing together diverse perspectives and voices made all of us better. The worst thing industry can do is to sit in a room and think we have all the answers. We must continue to seek out partners and listen to the voice of the patient as they add incredible value to what we do.
Why is clinical trial Diversity & Inclusion important?
Medical diseases and conditions may affect all people differently, but they still can affect anyone. We can only advance science and advance clinical outcomes for all patients if they’re represented in clinical trials.
In the U.S. and abroad, regulatory approvals for investigational products are based on clinical trials where the participant population enrolled in the associated trial reflects the composition of the general population or of those affected by the disease. Trials must reflect our diverse society, especially as populations shift.
The demographics of the U.S. population is significantly shifting. By 2045, it is expected that those currently identified as racial or ethnic minorities will become the majority. As these demographics change, it is paramount that the composition of trial participants also shifts. We have a responsibility to trial participants and patients to help ensure that medicines and vaccines that help protect everyone have everyone involved.
We believe that future mRNA medicines will be Moderna’s biggest contribution to society—inclusive of racial ethnic minority communities and vulnerable populations. By turning innovation into impact every day at Moderna, we can advance our mission for patients and help improve so many lives around the world.
How is Moderna building our capabilities to lead these efforts?
Diversity & Inclusion is grounded in Moderna’s core values and will continue to play an essential role in the way we conduct our business and our clinical trials. We believe that companies don’t run clinical trials, people do. So, we are investing in a talented team that has deep vaccine development experience, has led seven different vaccines to approval, includes a D&I lead who sits with our clinical development teams, and is committed to inclusivity at all levels.
As we continue to grow as a team and as a company, transparency will continue to be deeply important in building trust with our communities. During our COVE study, we published our un-redacted protocol for the world could see the design of our study. We went on to share our enrollment data every week on our website, making the demographic data available for all to see and holding ourselves accountable to a higher level of transparency.
Looking ahead to our CMV Phase 3 trial in 2021, we are already incorporating our COVE trial learnings into our plans for operationalizing this study. I’m pleased to share that we will be introducing demographic enrollment goals, and we will be transparent in our progress and hold ourselves accountable to meeting these objectives goals.
Where will we go now?
We recognize that there is not a “one size fits all” approach to cultivating inclusivity. To that end, we have centered our initiatives and efforts in support of our commitments around three main pillars:
Education: We are deliberate in our efforts to provide culturally appropriate educational
materials and recruitment support tools for different populations.
Transparency: We want to be very explicit in our intent to attain age, sex, and racial/ethnic balance, and we will provide regular updates to sites about our enrollment data, specifically as it relates to enrollment demographics.
Collaboration: We won’t try to do it alone. We proudly partner with sites, trusted community organizations and experts to help assure trial access is extended to all neighborhoods.
We have the opportunity as an industry to do the right thing and to break down barriers to inclusivity in clinical trials. As we build out our portfolio at Moderna, we will focus on reducing the barriers to diversity and inclusion in our clinical trials and ensure that we are open and transparent every step of the way.
What can we do to be part of the solution?
We have to do everything we can. Today, we are seeing unprecedented collaboration across organizations to solve the toughest health crisis of our time. It is our responsibility to capitalize on this momentum and bring others along with us.
Together, we will make a difference but we must take action:
Support diversity in STEM fields. Encourage students from underrepresented populations to consider a career in science, technology, engineering and math—so they can help design diverse trials and be a part of the solution on the frontlines of trial sites. Or, support universities and nonprofits with this same mission.
Join our team. Explore career opportunities at Moderna and help us pioneer mRNA medicines for all.
Forward-Looking Statement Disclaimer
This post contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the Company’s investments to accelerate the development of its mRNA vaccine pipeline; the Company’s talent recruitment efforts; the introduction and achievement of ethnic diversity enrollment goals for future clinical trials, including for the Company’s CMV vaccine; and efforts to improve education, transparency and collaboration. In some cases, forward-looking statements can be identified by terminology such as “will,” “may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continue,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. The forward-looking statements in this statement are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the year ended December 31, 2020, filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC’s website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this annual report in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.