$100M In Government Funding Helps, But What Can Really Be Done About Trial Diversity?

By Monique Gary, DO, breast surgical oncologist and medical director

Diverse representation in clinical research matters, and it has become increasingly clear from statistics that we have a long way to go to achieve it. While there has been an increased focus on innovative funding and policies to advance diverse participation in research, pervasive disparities in clinical science persist.

The White House Initiative on Women’s Health Research, funded through the Advanced Research Projects Agency for Health (ARPA-H), recently announced a $100 million grant to address challenges in women’s health across all demographics, geographies, and socioeconomic statuses. However positive this step may appear, it is only a partial effort to shore up a tottering healthcare system that has continuously let down communities of color and the underserved, which have historically been excluded from clinical science. The time has come to pivot to a new framework, powered by a multi-stakeholder consensus, to determine how we approach our biggest research challenges as they relate to health parity.

To create this new framework, we need to consider the roles of the various collaborators who drive clinical trial innovation forward, from design to implementation and from pilot to sustainability. We need to ask, “Is the right support in place for our research staff, clinicians, and clinical trial sponsors to advocate for increased representation, both within clinical trial populations and across leadership?”

On the research side, a 2022 study published in the Journal of Translational Science reported a disconnect between researchers’ support of diversity in clinical science as a whole and their belief in it as an important goal in their own specific research. Individual biases do play a role: researchers may unconsciously conduct trials favoring a specific group that they belong to or to which they have an emotional or personal connection. However, there are several barriers to effectively addressing these biases within the existing framework of academic structures, which we know suffer from issues including limited time, a lack of diverse leadership, and financial constraints.

On the clinician side, the tools and resources may not be in place to facilitate meaningful conversations regarding clinical trial participation. It may also be daunting and overwhelming to know how to kick off these conversations with patients within the limited time of a visit.

On the side of the sponsor, often the goal is to seek the broadest indication possible for a particular investigational product. Though well-intentioned, this “broad sweep” approach can have an adverse impact within our communities, as our bodies are not the same. For example, clinical trial research conducted in a specific subset of individuals with a lower socioeconomic status, or belonging to a particular racial or ethnic group, may yield dramatically different results than a study encompassing the broadest cohort, representative of the wider U.S. population.

While checks and balances, such as institutional review boards, are in place to ensure trials follow ethical standards and keep the best interests of participants front and center, often these safeguards do not account for the diversity of trial participants or mandate inclusion of diverse voices at the leadership and operations level.

We cannot continue to let outdated ideas and methods of data gathering inform our frameworks to create a healthier future. So, what steps can we take now?

• Multi-stakeholder collaboration is crucial for accountability. Having physicians, academia, advocacy partners, and patients sitting at the same table as clinical trial sponsors and CROs ensures that every research dollar is working for the communities we’re collaboratively trying to serve – it’s not just lip service, and we can make greater strides to make clinical trial research more accessible and broadly inclusive. For example, having more diverse voices in decision-making seats can help to develop frameworks around trial eligibility criteria, or help to amplify awareness and access to clinical trial sites in underserved or under-resourced communities. Having different perspectives at the table also creates more checks and balances and this transparency can also help to restore trust that has been broken between patient populations of color and others who have been marginalized by the clinical research world.
• In basic science research, we must create a framework for clear guidelines and consistent methodologies – for example, clearly defining patient populations and aligning on how patient characteristics are measured - so that these studies can be replicated for minority and underserved groups, including women, BIPOC, and LGBTQ+ communities. For instance, while women with dense breasts have a higher risk of breast cancer and Black women have up to 21%- 31% greater breast density compared to their white counterparts, the current screening guidelines fail to appropriately inform women about their risks as well as the screening modalities and frequency based on their breast density. Present screening guidelines heavily rely on outdated datasets, resulting in the exclusion of individuals and marginalized communities who may not fit traditional high-risk parameters. We must be guided by the failures of the past so that we can take steps toward fostering a more informed research community. In order to ensure the adoption and scalability of new frameworks, we need support from the FDA and global regulatory authorities to provide clear and directive guidance.
• Sponsors must work closely with the HCP, advocacy, and patient community to develop resources for patients to better understand what clinical trials are and how they may benefit them, as well as how to interpret existing research to inform their treatment and care journeys. We cannot, and should not, assume that patients will only rely on information from their doctors, so it's our collective responsibility to provide the right tools to help patients make informed decisions about their treatment and care options.

Accurate representation across the continuum of clinical trials is the right thing to do to improve the health outcomes of our communities. It is an act of public service. Let’s get excited about the potential and results that collective collaboration can yield in an effort to make clinical trials accessible and to make them work for all of us.

About The Author:

Monique Gary – “Dr. Mo” – is a breast surgeon, educator, entrepreneur, media personality, farmer, and philanthropist. Gary completed her medical degree at the Philadelphia College of Osteopathic Medicine, and her general surgery training at UMass, followed by the Breast Surgical Oncology Fellowship at Georgetown University Hospital. She holds faculty appointments in surgery and serves as the Associate Professor for Race & Health Equity at Dartmouth Geisel School of Medicine and as a medical advisor/contributor for national breast cancer advocacy organizations.

Gary is also building a movement to achieve true health equity and help communities develop holistic and integrative approaches to cancer care and wellness. She is CEO of Still Rise Farm, a 40-acre farm that was founded as a “wellness incubator” for cancer patients and under-resourced, marginalized communities. She can also be found on radioOne stations in Philadelphia giving tips for healthy living and cancer risk reduction, and weekly on Blackdoctor.org as the co-host of “The Doctor Is In.”