Representation matters: DRIVE guidelines aim to promote diversity in cancer clinical trials
A new study published in Blood Advances details guidelines for promoting diversity, equity, inclusion and access (DEIA) in cancer clinical trials. The study draws attention to glaring racial disparities in cancer care that are symptomatic of structural inequality and racism. It then proposes an actionable plan to combat under-representation in clinical trials in cancer.
Centuries of systematic racism in the US have resulted in racial disparities in healthcare including in cancer treatment and outcomes. Under-representation of Black and minority patients in clinical trials for cancer has resulted in misleading and ungeneralizable results.
The researchers cite that between 2008 and 2018, just 7.8% of trials recorded the four major races in the US (White, Asian, Black, and Hispanic). Additionally, minorities are massively underrepresented as trial participants with the actual trial populations consisting of 76.3% Whites, 18.3% Asians, 3.1% Blacks and 6.1% Hispanics.
Related content:
- “Patient activation” – a novel approach to create equitable interactions between patients and doctors?
- Establishing best-practice guidelines for antiracist patient engagement in AYA oncology research
- A call to action: antiracist patient engagement in adolescent and young adult oncology research and advocacy
This lack of representation is even more pronounced in certain cancer types, including those that have higher prevalence in Black US populations. Pooled data from nine clinical trials in newly diagnosed multiple myeloma, which is twice as common in Black individuals than White, showed that just 18% of participants were non-White. Underrepresentation affects patient outcomes too as many cancer patients receive treatment in clinical trials.
Frustration over the lack of inclusion of minorities in cancer research motivated Ruemu Birhiray and his daughter, Maya Birhiray both of Purdue University (IN, USA) to develop new guidelines for increasing DEIA in clinical trials. Their guidelines are informed by existing research and recommendations including the American Association for Cancer Research recommendations for myeloma clinical research. Their 5-step guidelines follow the acronym DRIVE:
D: Diversity officer for clinical research studies
Most clinical trials have obligatory diversity targets that regularly fail to be met. Appointing a qualified Diversity Officer would help enforce diversity targets.
R: Ranking system of clinical studies for diversity
A system for ranking the diversity of clinical trials would be easily understandable and apply pressure to reform. The establishment of a ranking system would allow comparison in DEIA efforts between pharmaceutical companies.
I: Individual diversity, equity, inclusion and access plan
Each team member should receive an action plan to ensure they are promoting DEIA.
V: Verification of study diversity
Clinical research teams would self-report their DEIA outcomes, however, data auditing should be conducted by review boards, organizations and regulatory agencies.
E: Elevate and Enhanced training of minority investigators and research team members
Diversity within clinical research teams should be encouraged at all levels, including leadership, and be promoted through funding, scholarships and training opportunities.
The researchers highlight that awareness and discussion of diversity issues has produced little meaningful change. In contrast, the actionable steps of DRIVE aims to produce enduring change in behavior across research, healthcare and education. The researchers hope to establish and implement policies based on DRIVE in partnership with medical societies. They explain that whilst DRIVE is a vision for the future, through outreach and publicity, the initiative can already begin to have real-world influence.
Ruemu Birhiray concludes: “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.”
