Diversity has certainly taken center stage in the clinical trial industry, with the FDA issuing guidance on the matter in November 2020: Enhancing the Diversity of Clinical Trial Populations – Eligibility Criteria, Enrollment Practices and Trial Designs Guidance for Industry. Here at Greenphire, we’ve observed many organizations looking to make a difference in this arena, both before and increasingly after the FDA guidance.

To help guide organizations to move beyond the problems that exist and discuss approaches and solutions, the DIA hosted its first ever meeting dedicated exclusively to Diversity, Equity and Inclusion in the Drug Development Lifecycle.

I was fortunate to be on the planning committee for the event, and a co-moderator for the session, Weaving a Tapestry: Multi-faceted Perspectives for Enrollment and Retention of Diverse Populations in Clinical Trials along with Monique Adams of Janssen and Diana Foster of the Society of Clinical Research Sites. Throughout my personal life, I’ve been dedicated to social justice, and since joining Greenphire, I’ve been able to combine my passion with our purposeful work to promote equitable access to clinical trials.

This session, and the entire day, was so inspirational; there was an energy that permeated the sessions, seemingly acknowledging that now is the time to make a difference. Companies, foundations, government, service providers and more came together to move the field forward through the discussion of new ideas and examples.

In this blog, I’d like to share some of the key learnings from the event, so that you may share with your colleagues and connections, building further connection and action plans.

Kicking it off: Robert Fullilove, EdD, Professor and Associate Dean, Columbia University Medical Center

The event began with a powerful keynote address from the lovely Robert Fullilove, friend to Dr. Martin Luther King, experienced minority health educator, and public policy expert. Fullilove focused on why these issues are so important right now, and it all comes back to the rapidly changing demographics of the US population. As the US becomes more diverse, the development of new medicines must include testing across all racial and ethnic backgrounds. We each have different risks and reactions to treatment, and as a result it’s essential to involve representative groups as part of research studies up front (“Nothing about me without me”).

The key question: how do we help diverse communities understand how science touches their lives, especially groups that may be isolated or distrustful of healthcare? Robert Fullilove gave examples of what not to do, stemming from his experience during the AIDS epidemic and lack of community engagement then, contrasted with what he advocates for today, and that’s more community-based participatory research. “The more a community sees visible input, the more they will believe science.”  Rather than waiting till an immediate need, building trust over time is crucial.

Today, discussions around health access and community engagement have been publicly playing out regarding clinical research and the release of vaccines to combat the COVID-19 pandemic. Public perception and distrust take time to rebuild, and there are steps we can take to show that we have the public’s interest at heart.

Five Clinical Trial Diversity Action Steps You Can Take Today

If there was one word that would sum up the DIA meeting, it would be “intentional” (Thanks @Kristine Baffo!).

But how – how can we be intentional about diversity?

We know that patients are waiting for drugs and new treatments on the other side of drug development, so the goal isn’t to delay the lifecycle. It’s about understanding what’s needed to engage diverse patients and include them at each stage of the overall study design from the outset.

Many pharma and CROs, as well as sites, have formalized both roles and strategies centered exclusively on increasing diversity of their trial patient representation.

I’ve pulled out several of the insights and actionable ideas they shared that you may want to explore further with your teams:

1 – Establish Non-traditional Partnerships

Robert Fullilove addressed the importance of community engagement, yet for community engagement to truly be effective, it’s essential that varying organizations (industry, nonprofits, government, service providers and more) come together for the purpose of awareness and education.

Latha Palaniappan, MD, SMs – Professor from the Stanford School of Medicine confirmed this approach, saying, “moving forward, non-traditional partnerships are needed to bring forth different organizational perspectives and power to address issues in a more united front.”

Presenter Richardae Araojo, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity for the FDA, is a key stakeholder in public-private partnerships. Her office creates communication tools for patients (such as this COVID-19 vaccine video) and collaborates with various stakeholders to identify and reduce health disparities. The office has numerous materials available here that may be helpful resources for you.

2 – Educate, Beyond Study-specific Information

The number one reason that individuals don’t participate in clinical trials is that they simply don’t know what they are or understand the importance of them. Of those who do participate, the majority enrollees are Caucasian. An example of proactive community education shared by Cassandra Smith of Janssen demonstrated the role of sponsors in community education. Check out this multimedia microsite detailing the clinical trial process and helpful resources: https://www.researchincludesme.com/.

She warned that people can see opportunistic behavior a mile away and “sew the seeds of research way before you actually start recruiting.”

Smith and others also suggested that you partner with trusted voices in the community. Maimah Karmo of the Tigerlily Foundation is a great example of turning adversity into purpose; diagnosed with breast cancer in her early 30’s, she now operates a national network of Angels that work with various community members for education and support.

Depending on the therapeutic area, there may be different networks that you can tap into to support community education and patient recruitment.

3 –Encourage Relatability Through Representation

Sites are on the front lines of recruiting diverse participants in clinical trials. Karri Venn, President of LMC Manna Research, a site network in Canada, shared many excellent examples of how she and her colleagues engage the communities that they serve. Canada, similar to the United States, is a melting pot of cultures. As such, to attract and retain similar participants, LMC Manna Research ensures that their materials and teammates are sensitive to the needs of their audience. First, her employees come from a wide array of backgrounds and speak 26 different languages (!). They also offer ICF in the language that the person is most comfortable with (in Karri’s words, it’s costly, but an important consideration). They listen to the community and offer pre-study education.

Diverse hiring and material creation was a common theme amongst the panels as a whole, from sponsors and CROs to sites and service providers.

4 – Identify New, Diverse Sites

Historically, sponsors and CROs turn to the same sites because they are able to enroll the needed numbers of enrollment. However, looking through the lens of representation, it’s important to identify new clinics that may offer a broader spectrum of potential participants.

Cassandra Smith suggests that we ask where patients are getting care, and place studies there. Give those clinics the tools to execute on research; remove the administrative burden so they can focus on diverse enrolment and patient care.

LaShell Robinson, Clinical Operations Lead Diversity and Inclusion, Janssen, is charged with finding ways to ensure that study populations are reflective of the world around them, often through a data science perspective. This new way of working spans communication with CROs, setting expectations for the study protocol and working with sites.

Setting expectations was a sentiment also shared by Lorena Kuri, MS, Head, Diversity Strategy for Brisol Myers Squibb. She frequently asks “Who is running the trials? Are the sites inclusive?” Diverse investigators are more likely to be trusted by patients and their communities.

Diana Foster, PhD, MBA, Vice President of Strategy and Special Projects for the Society of Clinical Research Sites, referenced the importance of sponsors to communicate diversity to sites as well as the new Diversity Site Assessment Tool available.


  1. Remove Challenges Faced by Sites

Dr. Fabian Sandoval, MD, Chief Executive Officer and Research Director for the Emerson Clinical Research Institute shared many concrete examples of successful patient engagement during the Clinical Trial Diversity and Inclusion session.

Known for his multimedia outreach, Dr. Sandoval works with the community and has vaccinated hundreds of individuals of Latin American decent; he has also increased his TV and radio show efforts designed to create awareness of healthcare opportunities. Check out his website here: www.tusaludtufamilia.com.

To ensure that populations participate in studies, it’s essential to remove challenges faced by sites. When he reviewed what the top challenges were faced by sites, number one on the list was participant transportation. He said ask every single sponsor to cover patient transportation, it’s needed for compliance, to ensure that patients have zero reasons to miss visits.

He also wants you to know, yes! You need materials in Spanish. Not just the materials, but preferably the technology too.

He also noted that yes, you need materials and technologies available in Spanish. Don’t wait to be asked, just have them ready. (We here at Greenphire agree – our ClinCard platform is available in 17 languages!)

Greenphire Resources for You:

You already know about our ClinCard and ConneX services which are used to remove patient burdens in clinical trials. We want to help you beyond offering these solutions to help you communicate and build patient engagement programs.

Here are resources available to you:

  • Video: We’ve created this video you can use to communicate about the importance of diversity planning and resource to help. Just copy and paste this link to share with colleagues, send to sites, etc.: https://www.youtube.com/watch?=zPEqc–2yns&t=1s
  • New brochure created in conjunction with CISCRP: Patient Costs & Reimbursements in Clinical Trials: This IRB-approved brochure can be provided to participants considering participating i na clinical trial to discuss potential expenses and reimbursements.  (Order printed copies for your office here on the CISCRP website; to be made available in Spanish as well!)
  • Connection: Given that we work with the industry’s leading sites, sponsors and CROs worldwide, we can help you connect with others like you who are actively working on diversity initiatives within their organizations. We can work to put together small group discussions amongst organizations to build your community and brainstorm. Email me at sitnick@greenphire.com to discuss opportunities further.
  • Education: Greenphire commits to providing ongoing tools with regards to diversity. We encourage you to join us for our upcoming session with Latinos in Clinical Research. Register now here!

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