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 · By Sanofi Admin

Diversity in Clinical Trials – And Why It Matters

This post was authored by Melva Covington, Director, Global Evidence and Value Development.

Clinical trials and the patients who partner with us in them are important to Sanofi every day.  That is why we were delighted to join other science-based companies in recognizing May 20 as International Clinical Trials Day.  We reflected on how partnerships between patients and healthcare practitioners are vital to producing high-quality, relevant research and understanding health outcomes   Sanofi US also focused on a related industry-wide challenge, namely, relatively few patients from diverse populations participate in clinical trials.

While African Americans represent about 12 percent of the U.S. population, it is quite troubling that, according to the U.S. Food and Drug Administration, they account for only 5 percent of clinical trial participants. The numbers are even more concerning when one considers Hispanic Americans, who make up 16 percent of the American population, but only 1 percent of clinical trial participants. These populations increasingly reflect the faces of people who use and benefit from innovative therapies like the ones that we produce.

To further put these numbers in perspective, we know that some medical conditions affect certain groups more than others. Take diabetes, for example. Compared to Caucasians, African Americans are on average twice as likely and Hispanic Americans are 1.7 times more likely to develop type II diabetes. Yet, they are often underrepresented in studies of promising new treatments. Research has also demonstrated race and ethnicity can affect the efficacy of certain drugs on clinical outcomes, such as beta blockers in the treatment of hypertension in African Americans.

Quite simply, while our clinical trial methodologies have evolved to address the need to include more individuals of diverse demographic and ethnic backgrounds in studies, oftentimes the enrolled patient percentage is not representative of U.S. demographics or the population most impacted by specific diseases.

The reasons for the disproportionate numbers of people of diverse racial and ethnic backgrounds in clinical trials are complex. However, we can get closer to narrowing the gap through education, a concentrated strategy to include these patients in our research and more effective engagement with patients to partner with us to achieve solutions.  We at Sanofi US are engaged in such dialogue and activities,  and are committed to making a difference.

Here’s one example. Sanofi has two new partners in raising awareness about the benefits of clinical trials: PatientsLikeMe and the Center for Information and Study on Clinical Research Participation. The partnership will focus on spotlighting “Medical Heroes” (those who “give the gift of their participation in clinical trials” to advance medical knowledge); increasing patient awareness about clinical trial opportunities; and advancing PatientsLikeMe’s mission to accelerate research by analyzing patients’ real-world disease experiences.

Through the partnership with these two highly patient-centric organizations, Sanofi will be able to engage patients, strengthen the overall public awareness of the realities associated with clinical research and hopefully accelerate the approval of medicines that clearly show a medical benefit for patients.

Increasing the involvement of diverse populations in clinical studies is also of tremendous importance to the members of ADVANCE, the Alliance for DiVersificAtion, iNClusion and Enrichment, a diversity employee resource group at Sanofi.  ADVANCE seeks to strengthen internal awareness and educate our employees on the issues related to diversity in clinical trials.  We are absolutely excited about it!

There is a wealth of information available about clinical trials and diversity in target populations as we engage more in this process.  The U.S. National Institutes of Health has an excellent web-based resource that provides easy-to-understand details about the types of studies available, what is involved for patient volunteers and much more; click here if you are interested. If you’re already knowledgeable about clinical trials and simply would like to find one, ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted in the U.S. and around the world.

In the pharmaceutical industry, it is critical to understand unmet medical needs as we bring new treatments, medicines, vaccines or devices to patients and communities. We seek to offer healthcare solutions in the most devastating conditions, such as cancer, diabetes, neurological and other diseases.  Being able to serve patients from diverse, targeted populations as partners of choice in our clinical trials is one goal on which we are clearly focused and we are doing this together.

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