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Challenges and strategies for improving representation.
Oncology is a complex field that requires the participation of a diverse patient population to validate the efficacy and safety of new treatments. However, oncology has been lagging in diversity inclusion in clinical trials. This article will discuss the importance of diversity in oncology clinical trials, the challenges faced, and ways to overcome these challenges to increase diversity inclusion.
Diversity inclusion has been an important topic in the biopharmaceutical industry this year. Clinical trials have made strides in including diverse patient populations, with white patients in trials dropping from 83% to 72%, and Latinx patient populations increasing from 3% to 18%, which is closer to real-world diversity figures.
Additionally, Pharmacies, such as CVS and Walgreens, have also aimed at increasing diversity in clinical trials. CVS, for example, has launched a clinical trial initiative aimed at increasing diversity in clinical trials by partnering with organizations that serve diverse communities. Moreover, Walgreens has launched similar initiatives as CVS on clinical trial diversity inclusion. But is this enough for oncology clinical trials?
According to a study published in the JAMA, only 5% of clinical trial participants are Black, despite making up 13% of the US population. Similarly, Hispanic patients only make up 1.3% of clinical trial participants, despite making up 18% of the US population. On the other hand, white patients make up roughly 70% of cancer clinical trial participants, although they only make up 60% of the US population. The data reveals a clear disparity in the representation of different ethnicities in oncology clinical trials, highlighting the need for diversity in clinical trial participation.
The challenge involves limited access to clinical trials for minority populations. Many minority populations face barriers such as lack of transportation, lack of insurance coverage, and limited access to clinical trials due to a lack of knowledge about the trials. Additionally, protocols may not necessarily be optimized to include diverse patients. These barriers can prevent minority populations from participating in clinical trials, limiting the participant population's diversity.
Oncology is a field that is constantly evolving, with new treatments and therapeutics being developed to treat various forms of cancer. However, clinical trials that lack diversity in their participant population may not accurately represent the general population and thus may not represent the treatments’ true impact.
One of the main reasons for the importance of diversity in oncology clinical trials is the prevalence of cancer in different racial and ethnic populations. Cancer incidence and mortality rates vary among different racial and ethnic populations, and this disparity highlights the need for a diverse patient population in clinical trials. For example, the incidence of lung cancer is higher in African American men than in white men, while breast cancer incidence is higher in white women than African American women (SEER Cancer Statistics Review, 1975-2017).
However, an important factor to consider is the genetic diversity among different populations, which can create limitations to diversity inclusion. To elaborate, cancer is a complex disease with a strong genetic component, and the genetic variations among different populations may impact diversity inclusion figures. For example, African Americans have a higher frequency of inherited BRCA2 mutations, which are associated with a higher risk of developing breast and ovarian cancer. Hence, a targeted therapeutic may focus solely on that particular ethnic population, and exclude whites. But, for many cancers, the knowledge obtained from genetic biomarkers and using treatments while maximizing ethnic diversity is crucial for developing effective treatments.
It would be prudent to conduct real-world evidence analyses to evaluate cancer rates amongst existing patient populations and devise trial participation to match ethnic groups in real-world settings.
Several strategies can be implemented to increase diversity in oncology clinical trials. One of the most important strategies is to increase awareness and education about clinical trials among minority populations. A common and well-known approach to engaging minorities can be made through community outreach programs like health fairs and benefit from the momentum that other sponsors and pharmacies have made with certain ethnic groups.
Another strategy is to increase the accessibility of clinical trials for minority populations. This can be done by partnering with community organizations and health clinics that serve minority populations. These organizations can facilitate the sponsor’s transportation offerings, non-standard of care coverage for study-related procedures, and other support services (i.e., insurance coverage) to help minority populations qualify and participate in clinical trials. Additionally, another consideration involves offering coverage for standard-of-care procedures to compensate for lacking coverage amongst ethnic groups.
Furthermore, clinical trial protocols should consider factors such as race, ethnicity, gender, age, and medical history to ensure that the trial results represent the broader population. Optimizing clinical trial protocols to include diversity can also help identify potential disparities in treatment response and ensure that new treatments are accessible to all patient populations. This can be achieved by proactively recruiting diverse participants, addressing potential barriers to participation, and carefully considering demographic data when designing and analyzing the trial results.
One less-known but effective approach is building clinical trial websites, and recruitment campaigns run online through social media or Google ads while combining AI-based technologies, such as engaging videos containing avatars representing ethnic communities who speak and engage minorities.
In conclusion, diversity inclusion in oncology clinical trials is crucial for developing effective treatments and improving understanding of diseases and their treatments. Despite some advances in clinical trial diversity inclusion, oncology is lagging in this aspect, with limited access to clinical trials for minority populations and a lack of diversity in participant populations. To increase diversity in oncology clinical trials, strategies such as increasing awareness and education, increasing accessibility, optimizing clinical trial protocols to include diversity, and using online recruitment campaigns and AI-based technologies can be implemented. Addressing the disparity in the representation of different ethnicities in clinical trials is important for ensuring that new treatments are accessible to all patient populations and accurately represent the impact of treatments on the general population.
Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.