As the coronavirus pandemic continues, we are witnessing some of the fastest and most widespread efforts in the history of clinical trials. Top researchers from across the globe are fast-tracking vaccination development, with some pharmaceutical companies already entering Phase 3 of their clinical research.
Beyond the progress of individual COVID-19 trials, the industry has seen an evolution in attitudes and increased awareness from the general population. Simply put, awareness among the general population that clinical research not only exists, but is vital to the health and safety of the world, has never been higher.
But while awareness is high, thanks in part to the conversations about potential vaccines and treatments, the pandemic is also having an operational impact on other studies. At SubjectWell, we’ve conducted several surveys with patients over the past few months to understand how their attitudes and feelings toward clinical trials have been altered in the wake of the pandemic. To date, our research has shown the percentage of patients who are considering clinical research continues to grow, and more patients are willing to participate immediately despite the pandemic.
Yet as we take a closer look at this data, we’ve discovered particular groups—specifically women and racial minorities—are more hesitant. These patients are concerned about potential virus exposure during in-office visits and other traditional trial events.
As trial sponsors and sites move forward, it’s critical to uncover how patients across all genders and racial groups are feeling, who is ready and willing to participate, and why.
Considering How Race and Gender Impact Clinical Trial Participation
According to a recent survey conducted by SubjectWell in partnership with the Center for Information and Study on Clinical Research Participation (CISCRP), men are less hesitant to participate in non-COVID-19 clinical trials than women, and women expressed a greater need for safety precautions if they were to participate. Additionally:
- Men were more likely to not be concerned at all about exposure to COVID-19 if they were to enroll in a clinical trial for a condition other than COVID-19 (23% of men, as compared to 13% of women).
- Women place a higher value on precautions like being able to communicate with a study doctor remotely, having study medicine delivered to their home, and knowing their health and safety would be protected when visiting the study clinic.
- Men do not feel that having a nurse come to their home for study visits is important.
The survey also found African American patients report more hesitations when considering participation in non-COVID-19 clinical trials and a greater desire for safety precautions if they were to participate compared to Caucasian patients. The survey found:
- 26% percent of African Americans responded that they are not at all likely to consider participation in a clinical trial for a medical condition other than COVID-19, as compared to 13% of Caucasians.
- African Americans are more concerned than Caucasians about being exposed to COVID-19 if they were to enroll in a clinical trial (56% of African Americans, as compared to 31% of Caucasians).
- African American patients are more concerned with precautionary measures like limiting the number of site visits and having the ability to send lab samples from home compared to Caucasian patients.
These altitudinal difference between racial groups are driven by a vastly disparate impact from COVID-19. According to the Center for Disease Control (CDC), infection rates among African Americans is approximately five times that of Caucasians.
Addressing the Lack of Diversity in Clinical Trials Through Patient Centricity
Existing social and health inequities are being brought into sharp relief as a result of COVID-19, and it’s happening at a time when the industry is collectively addressing the persistent issue of lack of diversity in clinical trials.
The National Institutes of Health (NIH) Revitalization Act of 1993 mandated the appropriate inclusion of women and minorities in clinical research; however, there has been a consistent lack of representation in clinical trials, with minorities making up less than 10% of trial participants. Additionally, according to a study published by the Allen Institute for Artificial Intelligence that looked at women’s participation in medical research from 1993 to 2018, researchers found that women were underrepresented, with major discrepancies in cardiovascular disease, hepatitis, HIV, chronic kidney disease, and digestive disease.
For sponsors and sites, structuring trials around patients and patient needs will be incredibly important as they recruit and enroll amid the pandemic. They should be aware that the ability to offer support services to address population-specific issues will affect not just overall participation rates, but the demographic composition of their trials. While concerns about COVID-19 exposure if enrolled in a trial continue to exist, the industry can put precautions in place to ease patient hesitation, especially within minority communities.
Collectively, the industry has the opportunity to use this once-in-a-lifetime event to address diversity in clinical trials through patient-centric improvements, ultimately building trust across genders and racial minorities in clinical research and healthcare in general.