CLINICAL TRIAL DIVERSITY COMMITMENT
According to the 2018 U.S. Census report, the year 2030 marks a demographic turning point for the United States. The size of the older population is expected to expand and the population of people who are more than one race is projected to be the fastest growing racial or ethnic group over the next several decades.
As the United States approaches a historic demographic shift, embracing inclusive clinical research is imperative for advancing healthcare that truly serves our increasingly diverse society.
For many years, most clinical trials included white male participants only. This meant that the information collected in those trials was not complete and could not help us learn how treatments affected other groups. This created a blind spot in our understanding of how treatments affect diverse populations.
Multiple cases can be found about how disease prevalence, treatment responses and disease burden can vary significantly based on age, gender identity, race, and other demographic characteristics such as socioeconomic status, disability, pregnancy status, lactation status, and co-morbidity. For instance, in the US:
- In 2014-2018, Black men had 6 percent higher cancer incidence and 19 percent higher cancer mortality than White men, reflecting lower survival rates.
- From 2014-2018, Black/African American women were just as likely to have been diagnosed with breast cancer; however, they were almost 40 percent more likely to die from breast cancer, as compared to non-Hispanic white women.
- In 2017-2021, Hispanic women were 42 percent more likely to be diagnosed with cervical cancer, and 14 percent more likely to die from cervical cancer, as compared to non-Hispanic white women.
- Asian Americans generally have lower cancer rates than the non-Hispanic white population. However, in 2018-2022, Asian/ Pacific Islanders were almost twice as likely to die from stomach cancer as compared to non-Hispanic white men, and Asian/Pacific Islander women were 2.4 times as likely to die from the same disease, as compared to non-Hispanic white women.
- In 2017-2021, American Indian/Alaska Native women were 68 percent more likely to have kidney/renal pelvis cancer than non-Hispanic white women.
- In 2001-2021, Black children were almost 8 times as likely to die from asthma as compared to White children.
- In 2020, non-Hispanic blacks were almost three times more likely to die from asthma related causes than the non-Hispanic white population.
- Melanoma is growing faster in women over age 50 than men over age 50.
The Food and Drug Administration (FDA) recognizes that these populations are frequently underrepresented in clinical research, despite bearing disproportionate disease burden for certain diseases and has issued guidance requiring sponsors to submit Diversity Plans which outline specific actions that will be implemented to enroll representative number of participants from populations that have been frequently underrepresented in research.
Incyte supports this effort, and is fully committed to:
- Investing in resources that expand our organizational knowledge and capabilities to ensure continued readiness to address this long-held challenge facing our industry.
- Incorporating a deep understanding of disease epidemiology as a foundational element in diversity planning.
- Engaging with patients, communities, and external experts to develop solutions to address participation barriers.
- Educating patients about the importance of clinical research and including community outreach as part of our clinical trial planning activities
- Identifying clinical trial sites that can recruit minority study participants.
- Removing participation barriers by increasing support services.
By prioritizing diversity in clinical trials, we aim to advance medical knowledge, improve treatment efficacy across all populations, and contribute to a healthier future for everyone.