Substantial evidence indicates that the efficacy of drugs or medical devices, the likelihood they treat the disease and the associated side effects and the severity of those effects, can vary greatly between people of different ethnicities/ancestries . Although funders and researchers have repeatedly expressed the need for multi-ethnic participants in clinical trials, recent figures indicate that nearly 86% of clinical study participants were white . Recently, as the digital age has made scientific communication much easier, accordingly, there has been a global expansion of clinical trial locations to design studies that represent more of the world’s population. Fortunately, the virtual space provides the necessary capabilities to run effective, and more diverse clinical studies.
Why is diversity and inclusion important in clinical research?
If a diverse population is not present in a clinical trial, it can lead to skewed results. It is important to adequately include participants from the population most affected by the disease for which a trial agent is being investigated in order to attain an accurate representation of the population. Moreover, each study needs to consider the correct diversity parameters that need to be met for yielding valid data.
One example discussed during the Diversity and Inclusion in Clinical Research Panel (part of a virtual industry event held by the National Institute for Health Research [NIHR] in 2020), is the lack of representation of the South Asian population in clinical trials for type 2 diabetes. It was stated that type 2 diabetes is “a lot more prevalent in the South Asian population, with around 11% of the type 2 diabetics in the UK being from this community, but actually their involvement in clinical trials is only approximately 5.5%” (3). This indicates that a community strongly impacted by this disease is grossly underrepresented in clinical trials designed to treat this disease.
In another example, it has been well documented that cases of COVID-19 are higher in the “BAME” (Black, Asian, and minority ethnicities) community. However, they have been disproportionally involved in clinical trials for COVID-19 therapies and vaccines. In fact, of the 400,000 people in the United Kingdom who registered to learn more about COVID-19 clinical trials, only 5% were from the BAME community, and a similar small percentage was seen in the elderly population (3). As there are numerous reports of adverse effects with recently approved vaccines, it is vital that these new anti-COVID-19 medications are evaluated in patients with multiple ethnic backgrounds.
How can virtual clinical trials address disproportionate representation?
Virtual clinical trials can address a major barrier challenging traditional clinical trial recruitment – accessibility. Virtual clinical trials are often conducted within a participant’s residence and on their own time, thereby eliminating the need for travel time and costs, time off for work, and childcare. When trials are decentralized, it also allows for more diverse recruitment to underserved areas that do not always have access to information about clinical trial opportunities. This platform of recruitment also allows potential trial participants to raise their concerns or discuss barriers that keep them from entering the trial protocol, thereby allowing researchers to tailor their protocol to increase accessibility.
Another important barrier with traditional clinical trials that virtual clinical trials is addressing is poor communication. For example, it is easier to ensure that all of the clinical trial documentation is available for translation in several different languages. Furthermore, as clinical teams are recognizing the strength of having more robust data from a diverse population from virtual clinical trials, there is a stronger push for ensuring that participants are provided with the technology to access the virtual platform.
It is important to start addressing the inequalities faced by underrepresented communities in clinical research. Not only will this strengthen the data collected during clinical trials, it will begin to help the communities disproportionally impacted by the diseases and conditions clinical trials are designed to treat. Virtual trials provide the platform to make clinical trials more accessible and provide clearer communication to underserved populations.
About the author:
Lindsay Gurska is a Cell Biology PhD trainee at Albert Einstein College of Medicine. She is interested in pursuing a career in science communication. Her current interest is in writing and creating promotional content for the therapeutic landscape.
- Ramamoorthy A, Pacanowski MA. Clin. Pharmacol. Ther. 2015, 97, 263-273
- Knepper TC and McLeod HL. Nature. 2018, 557, 157-159
- “Diversity and inclusion in clinical research”, NIHR Clinical Research Network Virtual Event for the Life Sciences Industry, 2021