A new study citing statistics showing 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, has outlined practical strategies that can help increase diversity, equity, inclusion, and access to these leading-edge studies.
The study, published in the journal Blood Advances notes that while cancer care disparities are well-documented, the same gaps present in healthcare are also seen in scientific research which can yield results that aren’t applicable to diverse populations. This lack of racial inclusion in clinical trials also affects patients outcomes.
“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.
Birhiray and his daughter, Maya Birhiray, BS, Purdue University, have developed a novel strategy to increase inclusion in clinical trials through their nonprofit organization, Indy Hematology Education, using the acronym DRIVE, which stands for:
- Diversity officer for clinical research studies;
- Ranking of clinical studies for diversity;
- Individual diversity, equity, inclusion, and access plan;
- Verification of study diversity; and
- Elevate and enhance training of minority investigators and research team members
The elements of DRIVE were informed by previous research. The recommendation to include a diversity officer in trials is based on existing recommendations for safety and monitoring boards to oversee all major studies. The DRIVE strategies were also derived 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.
Ruemu Birhiray puts special emphasis on the “R” in DRIVE, which he noted 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,” he said. “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 said 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.
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,” said Maya 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.”