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Perseverance Leads to Progress – ACRP

Now is the time to keep all stakeholders engaged in DEI in clinical research

A Q&A with Gilead’s Stacey Bledsoe, MSN, conducted by ACRP Executive Director Susan Landis 

This will be a critical year for professionals throughout the clinical research enterprise to build on the momentum gained in 2023 for improving diversity, equity, and inclusion (DEI)—not just among the volunteer participants in clinical trials, but also among all other stakeholders in their design, management, and results. 

In January alone, the U.S. Food and Drug Administration (FDA) released its Draft Guidance on the Collection of Race and Ethnicity Data in Clinical Trials and Clinical Studies for FDA-Regulated Medical Products. In addition, the National Academy of Sciences announced an important upcoming public workshop, titled Toward a Framework to Improve Diversity and Inclusion in Clinical Trials. This workshop builds upon previous meetings hosted by the Clinical Trials Transformation Initiative in June 2023, the Multi-Regional Clinical Trials (MRCT) Center of Brigham and Women’s Hospital and Harvard in September 2023, and the FasterCures Center of the Milken Institute in November 2023. 

Further, on Capitol Hill in late January, U.S. Reps. Mike Kelly (R-Pa.) and Chrissy Houlahan (D-Pa.) introduced the Harley JacobsenClinical Trial Participant Income Exemption Act,legislation that aims to exempt all payments received by participants in clinical trials from being counted toward their gross income. A former member of the Association Board of Trustees for ACRP, Jennifer Byrne, and her team at Javara were among the original signatories to the letter. This is a big step in the right direction. 

So many in our industry are taking the right steps with great hope that our perseverance is leading to progress. With this in mind, I reached out to Stacey Bledsoe, MSN, Head of Global Clinical Trial Diversity & Inclusion at Gilead, whom I had the pleasure of meeting this year and hearing speak at several forums on issues tied to DEI. What better time than at the precipice of a new year to check in on this crucial topic and wonder aloud if our collective perseverance is leading to progress. Please read on for her insightful feedback to the questions I posed. 

Let us start with the good news. What key progress can you report for advancing DEI in clinical research? 

The issue is front and center and we are engaged—everyone. I especially want to highlight site personnel, who play a unique role in advancing diversity in clinical research. In my roles at large pharmaceutical companies, I know first-hand that sponsors cannot do this alone, and that we need site personnel as trusted partners and as the voice for patients in order for industry stakeholders to understand the realities on the ground. Study teams are the link to patient care through clinical research and they always put patient needs first. In this way, their direct experience with patients allows them to serve as a bridge back to sponsors, contract research organizations, and the FDA about the real-world needs and opportunities for improving diversity in clinical research. 

At a recent MRCT meeting, you noted several times that “we are building the plane in the air” when it comes to defining how to improve DEI in clinical research. What parts of the plane do we have built? What remains, in your words, overwhelming? 

Well, let’s first applaud the FDA. We are no longer an industry that can ignore disparities in patient populations. Our challenge is how we’re going to respond to the FDA draft guidance to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials. 

In my role, I see a few significant challenges. First, and foremost, in terms of data. Today, many companies are leveraging real-world evidence (RWE) to support their diversity plans. In fact, RWE has even been touted as a way to increase equity, with the argument that observational datasets may reflect more diverse patient populations than randomized controlled trials (RCTs), thereby offering an opportunity to analyze safety and effectiveness in a representative cohort. At the same time, we contend we must be cautious in our use of RWE for health equity goals, as RWE data provide different information than RCTs, and the sole reliance on RWE, instead of the primary goal of increasing equity in RCT sample populations, risks actually increasing health disparities. 

For example, areas for potential bias in RWE that risk increasing disparities include: 

  • Social determinants of health—Factors such as lack or gaps in health insurance, employment, education, and access to healthcare services may bias these data. 
  • Poor interactions with the healthcare system—General suspension of healthcare may lead to certain populations avoiding interactions. 
  • The digital divide—Also, there is some risk that some populations may be missed due lack of internet record keeping. 

These are a few of the complications which must be kept in mind as the use of RWE increases and becomes further accepted in data collection for drug development. Therefore, we need to work with our researchers on how to properly leverage these data in the future. 

Another challenge is that the draft guidance for improving diversity in clinical research right now is specific to the U.S. FDA. This understandably leads to a lot of confusion about how to capture diversity data on a global trial. Most clinical research professionals who work on large studies lead global trials, so right now teasing through how to separately capture diversity data for U.S.-based participants is a complex effort we are still figuring out. We have to do a better job at clarifying this for study teams. 

The days that feel overwhelming are those when you realize that we have a lot of ground to make up. The good news is that I participate in several industry forums with my peers and colleagues from other pharmaceutical companies, and from industry associations in a precompetitive space where we are committed to sharing what we can for the benefit of lessons learned for everyone. These groups know that our work together is the right thing to do for patients, and we are 100% committed. 

One more thing: The draft FDA guidance provided a strong foundation. We are now looking forward to a final guidance which will help ensure we are meeting the needs of all patients. 

At that same meeting, you strongly recommended that study teams take small steps to improve DEI for clinical research. What would be your advice to our members, study leaders, and those responsible for improving diversity in clinical research? 

This is an easy one and follows what I said earlier—recognize your powerful role at sites in serving as the voice of the patient back to sponsors. We need your input about what you see on the ground that will help us all be successful. I am seeing a shift in our industry that sponsors and others understand that sites play a critical role in the ecosystem of success. I cannot say it enough—stand up and share your insights.