Why We Need to Harness Real-Time Data to Truly Drive Diversity in Clinical Trials
A look at the lessons learned from one platform approach to study enrollment tracking—and the wider quest for accountability in achieving diversity and inclusion goals.
The lack of diversity in clinical trials has been a persistent challenge for medical research. Black patients, for example, make up only 4% of cancer trial participants, much lower than their 14% share of the general US population.1,2 And similarly, Hispanic/Latino patients are approximately 8% of cancer trial participants but represent 19% of the country’s demography.1,2
The inequitable representation across racial and ethnic groups can be profoundly problematic, especially when you factor in the ramifications of only studying one patient group and how certain minorities may experience the same disease differently. For instance, Black patients have the highest cancer death rate and shortest survival of any racial or ethnic group in the US.3 Beyond cancer, Blacks tend to fare worse with chronic diseases, exhibiting greater mortality and lower survival rates.4 We need to fix this problem.
In 2022, FDA released new guidance5 to improve racial and ethnic diversity in clinical trials, which was a much-needed and long-overdue directive. Today, it is the responsibility of the industry to demonstrate that we are putting these guidelines into practice and holding ourselves accountable.
At Sanofi, we have done just that, taking this responsibility extremely seriously and dedicating resources to create a real-time data dashboard that is helping us improve diversity in our clinical trials, both in the present and future.
The challenge: How to build a platform to improve diversity
Clinical trials teams at most, if not all, pharmaceutical companies face the challenge of collating reports from several systems when developing executive summaries for their studies. This process takes time and makes it difficult to monitor data closely. If we want to leverage data to help improve diversity in clinical trials, we need tools that can address multiple data layers of trial recruitment, which are functions of the multitude of platforms that we leverage across our broad network of research facilities.
We need to measure, record, analyze, and communicate our trial enrollment data in real-time. This would allow us to adjust the protocols and alert our investigators throughout the process to improve the enrollment of underserved populations. Unfortunately, there are few options that could integrate all the different data systems and streams within a traditional clinical trials data infrastructure.
So, we built our own solution in-house at Sanofi. After over a year of development by a global team of data scientists and clinical trial specialists, we launched our real-time clinical trial enrollment tracking software application, called our Diversity and Inclusion Metrics Overview (DIMO) platform, internally in April 2022. This platform also helps to further hold us accountable for achieving our diversity and inclusion goals.
Lessons learned on improving diversity
Our efforts to improve diversity in clinical trials have led to three key lessons that we believe are essential for the broader pharmaceutical industry to understand.
1. We need to monitor demographics throughout trial enrollment.
We’ve already seen the impact that this process can make by helping us track the progress of patient recruitment against the data-driven goals set for each study. If we’re studying a more specific population, we look at the ethnic makeup of patients for this indication.
For instance, prurigo nodularis, a chronic skin disorder, has a greater impact on the Black population; although they make up only 14% of the US population, Blacks represent up to 44% of this patient population.6 Therefore, we need to recruit a large number of Black patients to participate in clinical trials of treatments for this disease. We have other trials where this is also true, such as sickle cell disease.
2. We should use data to develop patient experience narratives.
After we’ve stratified the available prevalence data by race and ethnicity, we prepare recruiters with what we call patient experience narratives to best understand the typical patient.
The narrative is a summary of data gathered from public sources but serves as a guide for where to recruit participants—states with higher numbers of disease, cities or rural areas, risk factors, the rate of increase of disease, and what that looks like five to ten years from now. These narratives help our teams propose diversity goals for trial recruitment, and once they’re endorsed, those goals then get entered into our platform.
3. We must be ready to make adjustments in real-time.
In clinical trials, inclusion and exclusion criteria ensure that the study population is properly represented and that participants are healthy enough to participate, particularly if they have any comorbid conditions beyond the condition being studied.
We do our best to ensure the criteria allow enrollment for a broad range of patients; however, if a specific criterion doesn’t account for hereditary differences between people from various races or ethnicities, it may unintentionally suppress participation of members from those groups.
To address this issue, we use our platform to track every criterion separately for each racial and ethnic group. The platform even has built-in features that alert stakeholders when trials have low enrollment and when certain demographics show high percentages of screen failures. This way, we can investigate and assess barriers.
Case study: Cutaneous squamous cell carcinoma study
In one of our studies on cutaneous squamous cell carcinoma, our initial plan was to focus on sun-exposed skin because it is where most people tend to develop their first lesions. However, we realized that this approach would not work for people with darker skin. For them, the first lesions are more likely to appear on covered skin instead of sun-exposed areas.7 If we had designed our protocol to focus solely on sun-exposed skin, that would have prevented a large percentage of people with dark skin from participating in the clinical trial.
While there was data available to prevent the unintentional creation of a recruitment barrier in the cutaneous squamous cell carcinoma study, that is not always the case. To account for this, we use our DIMO platform to monitor screen failures and alert us to address any criterion that disproportionately prevents the inclusion of individuals belonging to a particular racial or ethnic group. Upon receipt of that alert, we put together a mitigation strategy and proceeded.
Future applications and scaling
Since launching our platform internally, our clinical trials team at Sanofi has made continual improvements to make our trials more inclusive. We also expanded the reach of our DIMO platform to monitor our clinical trials in Brazil and the UK, where we faced different criteria for defining diversity due to varying regional diversity definitions. Our plan is to further develop our DIMO platform, incorporating the use of age and gender for tracking, and to bring the platform to other regions where we are conducting trials and that could benefit from more diverse clinical studies.
While the database is still evolving, our clinical trial teams at Sanofi are constantly giving our developers feedback to expand the platform. Our hope is to see progress in research that will translate to progress in the clinic, eventually improving health outcomes for underrepresented minorities. This is how we are holding ourselves accountable to the FDA’s trial diversity criteria and our society as a whole.
My hope is that sharing some of the important lessons we learned during our journey within Sanofi will inspire others within our industry to harness the power of data and develop innovative solutions that will enhance the inclusivity of clinical trials. In the end, this will enable more people to benefit from the therapies that we work so hard to create.
Monique Adams, PhD, is Executive Director and the Global Head of Diversity & Inclusion in Clinical Trials at Sanofi
References
1. Pittell, H.; Calip, G.S.; Pierre, A.; et al. Racial and Ethnic Inequities in US Oncology Clinical Trial Participation From 2017 to 2022. JAMA Netw Open. 2023. 6 (7), e2322515. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2807488
2. United States Census Bureau. QuickFacts. https://www.census.gov/quickfacts/fact/table/US/PST045222
3. Cancer Facts & Figures for African American/Black People. American Cancer Society. 2024. https://www.cancer.org/research/cancer-facts-statistics/cancer-facts-figures-for-african-americans.html
4. Ellis, K.R.; Hecht, H.K.; Young, T.L.; et al. Chronic Disease Among African American Families: A Systematic Scoping Review. Prev Chronic Dis. 2020. 17, 190431. http://dx.doi.org/10.5888/pcd17.190431
5. FDA, Diversity Plans to Improve Enrollment of Participants from Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability (April 2022). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/diversity-plans-improve-enrollment-participants-underrepresented-racial-and-ethnic-populations
6. Whang, K.A.; Kang, S.; Kwatra, S.G. Inpatient Burden of Prurigo Nodularis in the United States. Medicines. 2019. 6 (3), 88. https://doi.org/10.3390/medicines6030088
7. Munjal, A.; Ferguson, N. Skin Cancer in Skin of Color. Dermatologic Clinics. 2023. 41 (3), 481-489. https://doi.org/10.1016/j.det.2023.02.013
