The products and services we use should represent the society we live in. As a result, we’ve recently seen the focus shift to inclusivity, diversity, and equity in numerous industries. Unfortunately, the health industry and pharmaceutical companies are not as reflective of this development.
Despite the proven importance of diversity, inclusion, and accessibility in clinical trials, misrepresentation has been one of the key problems in these research studies. The COVID-19 crisis has only highlighted this issue further, contributing to the major setback that a lack of diversity has created in healthcare advancement.
To that end, this article will explore the importance of proper patient representation in clinical research trials, why this problem exists, and how we can solve it. Keep reading to learn more.
Why Is Diversity in Clinical Trials Important?
Successful clinical trials are one of the pillars that support health care. They examine and evaluate various products before they’re deemed safe and beneficial. However, many conditions must be met for clinical research to be successful, and one factor that’s been in the limelight recently is diversity.
Clinical trials need proper test groups to determine whether the products they’re testing are truly effective and safe. As a result, they need to include the groups that reflect the differences in race, ethnicity, gender, and age in the product’s intended patient population. This is necessary because individuals with different backgrounds respond to the treatment and adverse effects differently. If clinical trials don’t include diverse patient participants, there’s no way of telling whether the product is genuinely beneficial and safe for everyone.
Nevertheless, historical clinical research data shows certain patient groups have been continuously neglected. For instance, the 2020 clinical trials that led to the Food and Drug Administration’s (FDA) approval of original therapeutic biologics NS new molecular entities included only 6% Asian, 8% African-American, and 11% Hispanic or Latino participants.
This lack of diversity makes clinical trials inconclusive and prevents clinicians from drawing accurate conclusions.
Barriers to Diverse Participation in Clinical Trials
Diversity issues are not a new occurrence in the clinical research trial field. Trial investigators and sponsors have been dealing with them for a long time. As a result, they’ve devised multiple strategies to solve this problem. However, their implementation has produced mixed results due to various limiting factors. Let’s look at some of the barriers that hinder the progress of solving issues surrounding diversity in clinical trials.
Clinicians’ Engagement Impediments
One of the top strategies that could help improve diversity and inclusion in clinical trials’ test groups involves community clinicians. Extensive research has proven that patients are much more likely to consider participating in trials recommended by clinicians. However, several obstacles stand in the way of their engagement in this kind of research:
Lack of awareness and knowledge of clinical trials — Clinicians not affiliated with research institutions or larger medical centers are usually unaware of the research being conducted. In addition, they have no training, support, or resources necessary to facilitate sustained patient research participation.
Lack of time, compensation, and recognition — Identifying suitable matches and forwarding those patients to clinical trials requires time and commitment. So, clinicians deserve an incentive and recognition for these efforts. Physicians don’t have the resources or motivation to dedicate time to this without them.
Concerns about patient/clinician relationships — Clinician/patient relationships are built on trust and loyalty. Many medical professionals worry that clinical trial recommendations might interfere with those relationships and make patients doubt their true intentions.
Lack of trust in clinical trials — Numerous clinicians, like much of the healthcare industry, don’t see clinical trials as part of the care continuum. As a result, they avoid recommending participation in this type of research to their patients.
Lack of Access to Trials
Another contributor to the absence of diversity in clinical trials is the lack of access to these research practices. Studies have shown that only 8% of cancer patients participate in clinical trials, even though more than 50% of them would like to if given the opportunity.
Numerous factors have contributed to this problem. Some of them include lack of access to healthcare due to structural inequalities, financial issues, geographical distance, lack of time due to work schedules, etc.
Of all these aspects, current site-selection practices might be one of the biggest problems. Namely, industry sponsors use the same investigators and large sites, like major medical centers, for patient recruitment and enrollment. These sites and investigators are not involved in providing care to underprivileged populations, so members of these communities don’t have access to trials.
Benefits of Clinicians’ Engagement in Clinical Trials
Involving community clinicians that work with diverse populations in clinical research can be beneficial in many ways. Because these clinicians work in areas with underserved populations, they can be a constant source of access to trials for these groups. They already have established relationships of trust with their patients, so they can easily pass on information about trials. Patients can learn the trials’ objectives, how they are conducted, and what benefits and risks they involve.
Community clinicians can also help extend the trials’ reach and recruitment practices. They can engage in planning by checking whether the trials’ logistics are proper. Moreover, they can ensure that enrollment criteria are achievable and that the trial population matches the tested product’s potential users. These changes would make translating clinical research results to actual clinical care much more seamless.
Implementing the Necessary Changes
The need to broaden the research base has existed in the clinical research community for a while. Nevertheless, the recent health crisis has exacerbated it by making patient recruitment even slower and more competitive. To solve this problem, we need to bring awareness of the interdependence of clinical research and clinical care to the entire research community.
From the biomedical industry to patient advocates, there should be support for establishing a framework that connects these two fields. As a result, the research centers will have enough funding and endorsement to recruit community clinicians as investigators and provide them with the training and financial resources they need. They’ll also have access to the technology that enables data collection and monitoring and facilitates the enrollment and participation of demographically and geographically diverse groups.
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