Diversity in clinical trial participants is vital to understanding the safety and efficacy of novel drugs across heterogeneous population subgroups. However, diversity is a feature that is often missing in clinical trials.
According to a cross-sectional study examining the data from a total of 230 US-based vaccine trials conducted between 2011 and 2020, racial and ethnic minority groups are significantly underrepresented in clinical research. The study found that the enrolment of African Americans (10.6%), American Indians or Alaskan Natives (0.4%), and Hispanic or Latino individuals (11.6%) in vaccine trials was significantly lower as compared to that of white individuals (77.9%).
Lack of clinical trial diversity and its impact
The lack of diversity in clinical trials may have severe consequences for patient safety. For instance, according to a recent study published in Feb. 2021, only 8.2% of participants in pancreatic cancer clinical trials are African American, even though this population subgroup makes up 12.4% of pancreatic cancer cases in the U.S. This significant disparity leads to an inability to fully explore patient outcomes in clinical trials and may impact patient safety by causing rapid disease progression, severe and unwanted adverse events, prolonged hospital stays, and increased financial burden.
Another example of the harmful effects of lack of non-uniformity in clinical research is the anti-HIV medication, Efavirenz. This drug metabolizes at a slower rate among patients of African descent. However, researchers failed to discover this fact initially, as patients belonging to this population subgroup were not enrolled in Efavirenz trials in adequate numbers. This lack of diversity resulted in the development of resistance to Efavirenz in many patients taking this medication.
Underrepresented racial and ethnic minorities are already distrustful of the healthcare system, and the pharmaceutical industry has a poor reputation among the general public. Inadequately powered clinical trials can further undermine patients’ trust in the healthcare system and may aggravate this problem.
Role of regulators in promoting clinical trial diversity
In 2020, the United States Food and Drug Administration (FDA) issued guidance to enhance diversity in clinical trials. It recommended that clinical trial sponsors widen the eligibility requirements to allow a broader range of participants to enroll. It also encouraged the sponsors to pay for study-related expenses and consider using digital health technology tools to reduce the frequency of site visits, while providing real-time data to the investigators.
The All of Us Research Program is a national effort funded by the National Institutes of Health (NIH) to address the need for diversity and inclusion in clinical research. This program focuses on building one of the most diverse national health databases in history. It strives to understand which population subgroups are traditionally underrepresented in biomedical research and emphasizes the importance of enrolling racial and ethnic minorities in clinical trials.
The Diverse and Equitable Participation in Clinical Trials (DEPICT) Act is another endeavor that aims to strengthen diversity and inclusion in clinical trials. Introduced on February 3, 2022, this bipartisan bill requires enhanced data reporting on clinical trial enrolment by demographic subgroup, including age, race, ethnicity, and sex. Additionally, the bill will require the sponsors to provide a Diversity Action Plan that explains the steps sponsors will take to boost diversity in their trial populations. The legislation also focuses on providing resources to underrepresented groups to improve access and participation in clinical research and authorizes funding to the NIH for community engagement and outreach efforts.
How can technology help in boosting diversity?
Utilizing technology in capturing health-related data has taken the clinical trial industry to a new level. Decentralized trials are becoming more and more popular. Many studies using wearable technologies are already underway, and around 70% of clinical trials are expected to use wearable devices by 2025. The COVID-19 pandemic further promoted the idea of remote trial participation. Social media also creates a massive difference by connecting with varied population subgroups about clinical research opportunities.
However, there is still a considerable disconnect between clinical research and diverse populations. Not every individual has the same access to technology, which is especially true for minorities and participants of lower socioeconomic status. Finally, certain technologies may only be available to individuals from specific geographic locations. For example, a particular technology may only be available to trial participants in large metropolitan areas. These disparities result in the omission of potential trial participants who reside in rural areas and hard-to-reach locations, leading to the skewing of trial data. Similarly, patients belonging to lower socioeconomic backgrounds may not be able to afford smartphones, tablets, or even reliable, high-speed internet, which may be required for participation in some studies. In fact, the lack of diversity in clinical trials may parallel the lack of diversity in the technological pool.
Therefore, it is essential to create diverse technologies that can easily be made available to different patient populations. These technologies should focus on increasing the opportunities for racially, ethnically, geographically, and socio-economically diverse patients to participate in clinical trials. Browser-based, bring-your-own-device (BYOD) solutions should be made available to patients all around the globe. The industry should develop screening and recruitment tools to identify commonly underrepresented patient groups. In addition, the study sponsors ought to ensure that access to advanced technology is available to all trial participants.
Clinical.ly supports diversity and inclusion in clinical trials
Diversity and inclusion are critical when it comes to healthcare, clinical research, and new drug development. Clinical.ly is a strong proponent of enrolling diverse patient populations in clinical trials. We offer technological solutions that make it easier for clinical research sites to address regulatory tasks, thereby allowing staff to focus on participant recruitment and patient safety.
Contact us today to schedule a consultation to learn more about our advanced technological solutions!
