Diversity is everyone’s responsibility: Researchers outline a path to representation in cancer clinical trials

Lifestyle

A new study published today in Blood Advances outlines practical strategies for promoting diversity, equity, inclusion, and access in cancer clinical research. The study highlights significant racial disparities in cancer research, citing that between 2008 and 2018, only 7.8% of clinical trials documented the four major races (including white, Asian, Black, and Hispanic populations) in the United States.

Racial disparities persist in cancer care due to systemic inequities and structural racism in housing, education, employment, and the criminal justice system. And the gaps are not just present in health care but also in scientific research, which can yield misleading or ungeneralizable results when studies fail to include diverse patient populations. Further, since many people with cancer diagnoses receive treatments from clinical trials, the lack of racial representation in clinical trials affects patient outcomes as well.

“There are things we can do today that can change the trajectory of minority patient inclusion in clinical trials that do not require legislation. They are actions that are within our immediate reach,” said study author Ruemu Birhiray, MD, a clinical oncologist at the Hematology Oncology of Indiana Division of the American Oncology Network.

Frustrated by the lack of inclusion of minorities in cancer research, Dr. Birhiray and his daughter, Maya Birhiray, BS, Purdue University, developed a novel strategy to increase inclusion in clinical trials through their nonprofit organization, Indy Hematology Education, Inc. They communicate this five-step approach using the acronym DRIVE:

D: Diversity officer for clinical research studies
R: Ranking of clinical studies for diversity
I: Individual diversity, equity, inclusion, and access plan
V: Verification of study diversity
E: Elevate and enhance training of minority investigators and research team members
Each element of DRIVE was informed by previous research; for example, the recommendation to include a diversity officer in trials is modeled on existing recommendations for safety and monitoring boards to oversee all major studies. Additionally, DRIVE strategies were pulled from existing guidelines, including the American Association for Cancer Research recommendations for myeloma clinical research, and real-world examples from other fields, such as an economic rating index used by the World Bank to influence global regulatory policy.

Dr. Birhiray emphasized the “R” in DRIVE, which he explained is the idea of ranking clinical trials based on how diverse their patient populations are.

“We believe that ranking can change the way researchers behave,” said Dr. Birhiray. “We live in a country where everybody wants to win, and keeping score motivates people. No one wants their study to have a low ranking. Beyond study ranking, we also know the value of scientific presentations in the research field. If you have a limited number of podium presentations, and we require you to prioritize the presentation of studies that represent everyone, I think it will force our research community to innovate.”

The authors describe that the action items outlined in the initiative value creating long-term permanent shifts in behavior, and enacting DRIVE will have a ripple effect on medical research, education, and treatment. Informed, care providers will practice with a greater intention to provide their patients with superior, more individualized treatment.

Going forward the Birhirays intend to focus their outreach strategies on advocacy. In the next few months, they plan to host a summit surrounding the Indy Hematology Education, Inc. 19th Annual Meeting. They have also begun writing a piece they refer to as a Black Paper: a white paper focused on creating representation of marginalized identities in cancer research. Through the article, they hope to bring together medical societies in cancer care and establish a set of policies that can make DRIVE a reality and an industry standard.

“It’s important to communicate that tangible things are being done to make medicine more applicable to everyone,” said Ms. Birhiray “We want people to know that medicine is a field open to everyone and that our community values them.”

While DRIVE is currently a vision for the future of clinical cancer research, authors voiced that with publicity and outreach, it can begin to have real-world effects.

“Diversity is everyone’s responsibility,” emphasized Ms. Birhiray. “And as we touched on in our paper, diversity isn’t just racial and ethnic diversity. We must also consider factors like socio-economic groups, sex, gender, age, and career stage. In order to conduct research that applies to everyone, we must make concerted efforts to include all minority populations from the inception of a clinical trial.”