By: Leah Smith, MSc., Head of Diabetes Trials, Medialogix
Achieving Participant Diversity in Diabetes Clinical Trials: Challenges and Considerations
By: Leah Smith, MSc., Head of Diabetes Trials, Medialogix
Achieving Participant Diversity in Diabetes Clinical Trials: Challenges and Considerations
Diabetes clinical trials need to have a diversity plan because there can be a difference in disease burden when comparing people of different races and ethnicities.
Diversity is a crucial factor in clinical trials, especially in the field of diabetes research. The need for inclusion and diversity has been emphasized by the US Food and Drug Administration (FDA), which has implemented guidelines to increase diversity in clinical trials since 1993. The FDA has also recently released draft guidance for industry to improve enrollment of participants from underrepresented racial and ethnic populations in clinical trials.
The racial and ethnic makeup of the US is changing, with a predicted increase in diversity by 2045. Thus, it is important to promote enrollment of diverse patient populations in clinical research and clinical trials. Age distribution and geographic location are also factors that need to be considered when designing a clinical trial around patient diversity.
“You are completely ignoring the 40 percent of the US population who identify as racial or ethnic minorities if you fail to design your trial with a plan on how you will engage with these participants. Enrollment will be slower, and you'll be starting on the wrong foot,” says Dr. Manjeet Singh, MD, Medical Director from the global clinical research organization (CRO) Medialogix.
The Diversity of the US Population
The racial and ethnic makeup of the US is changing. For instance, the proportion of White (non-Hispanic) people in 2010 was 63.8 percent and in 2020 it was less than 60 percent. In 2020, the largest racial and ethnic groups after the White (non-Hispanic) population was Hispanic/Latino (19.6 percent), Black (12.6 percent) and Asian (5.9 percent).
It is important to consider how the US racial and ethnic populations may change in the future because on average, an investigational product can take five to seven years to undergo Phase I to Phase III development, and this is ideally followed by at least 10 to 15 years of commercial value.
It is predicted that by 2045, more than 50 percent of the US population will be other than White (non-Hispanic). Therefore, the US population will change and become more diverse. As a result, there must be a plan to promote enrollment of diverse patient populations to ensure appropriate representation in clinical research and clinical trial efficiency.
One key aspect of promoting equity in clinical research is ensuring that study protocols are inclusive and appropriate for the target population.
Diversity in clinical research is crucial for equity and inclusion. There can be a difference in disease burden when comparing people of different races and ethnicity, as shown in cardiology and oncology examples. Clinical trials need to have a diversity plan to ensure that the right drug or device is given to the right patient at the right time.
Study design considerations need to take into account diversity, with methodologies that allow for more flexibility regarding eligibility criteria, broadening the inclusion criteria and evaluating exclusions that may preclude the enrollment of underrepresented groups. Trials with technology alternatives or decentralized trials can also improve accessibility.
Patient diversity in clinical trials is achievable with a well-thought-out diversity plan and close collaboration between the CRO, sponsor and sites. It is essential to strive for diversity in clinical trials to ensure equitable healthcare for all patients, regardless of race or ethnicity.
“By engaging with local patient advocacy organizations, you can build a trusting relationship with the diabetes patients you'd like to participate in your trial,” explains Dr. Singh.
Why Should We Care About Diversity and Equity in Clinical Research?
Equity in clinical research refers to ensuring that all individuals have equal opportunities to participate in clinical trials, regardless of their race, ethnicity, gender, age, or socioeconomic status. Historically, certain populations have been underrepresented in clinical research, leading to disparities in health outcomes.
One key aspect of promoting equity in clinical research is ensuring that study protocols are inclusive and appropriate for the target population. This requires considering factors such as language barriers, cultural beliefs, and health literacy levels when designing study materials and informed consent forms. Additionally, researchers must actively engage with potential participants to build trust and establish relationships that promote ongoing participation in the study.
Equity in clinical research also involves addressing any disparities that may exist in the distribution of research resources and funding. Historically, certain institutions and geographic regions have received more funding for clinical research, resulting in a lack of access to clinical trials for many individuals. To promote equity, funding agencies and research organizations must prioritize funding for studies that address health disparities and prioritize recruiting diverse populations. Additionally, efforts must be made to provide adequate resources for underrepresented communities, including transportation and childcare services, to facilitate participation in clinical trials.
"Diversity and inclusion aren't just buzzwords - they can make a real difference in the lives of patients," says Olivia Garcia, Clinical Research Manager, Medialogix. "That's why organizations need to take a top-down approach to diversity in trials to ensure that all employees buy into the importance of this mission."
“Trial coordinators need to find a way to reduce participant burden and bring the study to patients in order to deliver on promises of diversity.”
– Dr. Manjeet Singh, Medical Director, Medialogix
"Patient interactions with the research team are crucial; when trial participants feel heard, we see much higher retention rates."
– Olivia Garcia, Clinical Research Manager, Medialogix
Considerations for Study Design with a Focus on Diabetes
In planning a clinical trial, it is essential to consider approaches for achieving diversity, equity, and inclusion (DEI), especially for diseases like diabetes that disproportionately affect certain populations. Trial methodologies should be flexible and considerate of potential barriers such as location, transportation, frequency of visits, and financial constraints.
According to Dr. Singh, an endocrinologist with expertise in diabetes, “There are innovative methodologies that can be explored to improve diversity, such as broadening inclusion criteria or evaluating exclusions that may be preventing the enrollment of underrepresented groups. For example, in diabetes trials, fasting glucose levels are often used as an inclusion criterion, but this may exclude certain ethnic groups who are more likely to experience postprandial hyperglycemia.”
To enhance accessibility and promote patient diversity, study designs with technology alternatives such as remote patient sensing through wearables or decentralized trials should be considered. Additionally, geographic diversity is frequently considered when selecting sites for clinical research, but it is equally important to pay attention to the diversity of the research team at the site. Engaging participants in multiple languages by having a diverse team of PIs, recruiters, and other research staff can also contribute to achieving greater patient diversity.
Achieving patient diversity in clinical trials requires a well-designed diversity plan and close collaboration between the sponsor, CRO, and sites. With a DEI focus in study design, clinical trials can help address the disparities in diabetes care and outcomes among diverse populations.
Author
Leah Smith, MSc.
Leah is the head of diabetes trials at Medialogix. She has 10 years' experience managing all aspects of trial delivery, from study start-up to data delivery.
Sponsor
About Us:
Medialogix is a global, full-service contract research organization (CRO) providing clinical development services to companies developing drugs and devices for diabetes indications.
