Breaking down the buzzwords: What does it really mean to run inclusive clinical trials?

Diversity, Equity, and Inclusion (DEI) sits at the heart of everything we do at Langland and is integral when we build human clinical trial experiences, but what is “true” inclusion when it comes to clinical trials??

I asked Sasha Sakay, Manager, Strategy at Langland: how can we think beyond preexisting notions around representation and challenge the status quo in order to build truly inclusive clinical trial communications?

We’ve seen the industry strides taken in recent years to create and support more diverse clinical trials. From the Food and Drug Administration (FDA) diversity guidance to implementation of the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act, we have made progress in collecting and reporting on diversity metrics, as well as in recruiting diverse populations?within clinical trials. However, there is still a long way to go in ensuring trials are fully inclusive and representative of all affected communities.

We hear industry leaders refer to "underrepresented" groups, but what does that really mean? An underrepresented group is a subgroup of a population whose representation is disproportionately low, relative to their numbers in the general population. This means that communities considered "underrepresented groups" in clinical trials can vary by health condition, country, and patient community.

Our diversity efforts must therefore go beyond baseline demographic measures like race and ethnicity and should actively consider the unique intersecting identities that make up a human being. Recognizing the overlap of characteristics like age, sex, gender, ability, and socioeconomic factors that create an individual’s unique needs and motivators, moving from a?patient-centric to a?people-centric focus.

While marginalization is rooted in historic and ongoing systemic discrimination, as an industry we typically do not pay enough attention to different and distinct subsets within a larger patient population. If we continue to treat demographically-defined groups as a monolith, we won’t ever be able to see the full picture. It’s imperative we move away from equating “majority” with “most important” or even “most profitable.” This majority-first mindset disregards those that still need and deserve support.

We’ve seen the consequences of exclusion across many conditions, but a recent example is breast cancer public awareness and advocacy campaigns. “Pink” campaigns and charities have had an undeniable impact in empowering women living with breast cancer, but this focus has unintentionally contributed to a pervasive stigma regarding breast cancer in men and in those with other gender identities.

In 2023, approximately 2800 men (about one in every hundred US cases) were diagnosed with breast cancer. While this diagnosis is less common, the impact is just as significant. Since breast cancer is commonly perceived as a “woman’s disease,” men tend to ignore symptoms (or are not taught to recognize the symptoms) resulting in late diagnosis and poorer outcomes. It’s important to recognize the power that public communications have in the health space. It goes beyond advertising, as messaging can affect both disease perception and seeking care.

Typically, clinical trials and recruitment strategies are built on the shared?clinical?experiences of the?majority. In moving towards more inclusive practices, we should consider all affected subgroups and craft trial experiences around shared drivers and barriers in relation to?lived?experience.

At Langland, we look to find the common thread that is undefined by a specific identity (gender, race, age, ability, etc.), while also becoming aware of what specific disparities and barriers exist for each group so concerns can be addressed or supported as needed—equity. We then ensure that the shared trial experience and engagements that we create do not exclude or ignore anyone—inclusivity.

For example, we know there are significant disparities in care and outcomes for Black patients as compared to white patients across both females and males in the US. Black people with breast cancer have the highest death rate and shortest survival of any racial/ethnic group within the US. Approximately 15% of patients with cancer in the US are Black, while only 4% to 6% of cancer clinical trial participants are Black.

We should offer more targeted considerations to increase Black representation in clinical trials, but that does not mean treating the Black community as a singular homogenous audience. We should also understand the differences between two people with the same racial identity living with cancer and how their income, geography and personality all play into their care motivators and health journey.?

By recognizing all the dimensions that make up the diversity of a person, we can see people for who they are as a whole—not just a target racial or clinical identity—and create meaningful, targeted communications that celebrate our differences.

1.?????Breast Cancer in Men. Centers for Disease Control and Prevention. Reviewed September 26, 2022. Accessed July 26, 2023. https://www.cdc.gov/cancer/breast/men/index.htm

2.?????What to Know About Male Breast Cancer. Breast Cancer Research Fund. Created June 5, 2023. Accessed July 26, 2023. https://www.bcrf.org/blog/male-breast-cancer-statistics-research/

3.?????Neighmond, P. When Men Get Breast Cancer, They Enter a World of Pink. NPR. Created February 8, 2016. Accessed July 26, 2023. https://www.npr.org/sections/health-shots/2016/02/08/465578231/when-men-get-breast-cancer-they-enter-a-world-of-pink

4.?????American Cancer Society. Cancer Facts & Figures for African American/Black People 2022-2024. Atlanta: American Cancer Society, 2022.

5.?????American Society of Clinical Oncology. Nearly Half of Black Patients with Metastatic Breast Cancer Are Not Informed About Medical Trials [Press Release]. Retrieved from https://old-prod.asco.org/about-asco/press-center/news-releases/nearly-half-black-patients-metastatic-breast-cancer-are-not#:~:text=Approximately%2015%25%20of%20patients%20with,the%20U.S.%20in%202020i.

6.?????Editorial Board. Breast Cancer, Male: Statistics. Cancer.Net. Approved February, 2023. Accessed August 4, 2023. https://www.cancer.net/cancer-types/breast-cancer-male/statistics