The importance of diversity in clinical studies
Importance of diversity in clinical studies.. Why Inclusion Matters?
Understanding the burden of cancer
Individuals identifying as Black or African American represent 13.4% of the U.S. population,* yet only 5% participated in oncology studies in 2020.** Additionally, there is a 9% greater incidence rate for all cancers among non-Hispanic (NH) Black versus NH white males and a 22% higher death rate for all cancers among NH Black versus NH white males.***
Minority populations in the U.S. are greatly underrepresented in clinical studies yet tend to have higher cancer rates when compared to the general U.S. population. There are many different barriers to diversity in cancer clinical studies, including healthcare access, cost of care, vigorous eligibility criteria (factors more prevalent in U.S. minority populations) and patient mistrust. Diversifying clinical study participation improves the overall conduct of clinical studies and helps reduce disparities in cancer care. Ultimately, diversity among study participants is important to understanding factors that may affect response to cancer treatments.
Research brings new possibilities
People of all backgrounds, who are either healthy or have preexisting conditions, participate in clinical study research all over the world. You can too. Clinical studies bring the hope of new medicines and medical devices to reality for many of today’s challenging conditions. Explore whether a clinical study might be right for you.
The impact of diversity in studies
Because people of different backgrounds may react differently to certain medical products (medicines and medical devices), diversity in clinical study participation is key to advancing health equity. Diversity provides a more completed picture of a product’s efficacy and potential side effects. Thus, when participants of varying demographics join a clinical study, such engagement drives deeper clinical insights that more accurately represent the full spectrum of patients who will use the medical product.
Common Myths:
1. Clinical studies are experiments and people are treated as guinea pigs
We are committed to the safety of each and every participant who enters a clinical study. Participants are watched very closely by their healthcare team to ensure best patient outcomes.
2. Clinical studies are not safe because they use medicine never used before.
Before any investigational drug can be given to humans, it goes through complete rigorous testing, screening and regulatory review to ensure maximum possible safety.
3. Participants are not informed during the clinical study.
Before every clinical study, our participants review a detailed protocol that discloses the known risks and benefits associated with the study. Each participant is treated with respect and dignity throughout the entire process and can withdraw consent from participation in the study at any time, for whatever reason.
Get in touch to learn more about diversity in clinical studies.
If you think a clinical study may be right for you, talk to your healthcare provider.
You can also search for clinical studies in your area at clinicaltrials.gov
To watch videos and view a list of questions to ask researchers, visit www.hhs.gov/about-research-participation
For more information on health equity, visit www.fda.gov/healthequity
*U.S. Census Bureau. QuickFacts. July 2021. https://www.census.gov/quickfacts/fact/table/US/PST045221
**U.S. Food and Drug Administration. 2020 drug trials snapshots summary report. https://www.fda.gov/media/145718/download
***American Cancer Society. Cancer facts & figures for African Americans 2019-2021.
Incidence rate data was collected between 2011 and 2015. Death rate data was collected between 2012 and 2016. https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/cancer-facts-and-figures-for-african-americans/cancer-facts-and-figures-for-african-americans-2019-2021.pdf
