Source: Pharmacy Times
With the ongoing COVID-19 pandemic, the importance of rigorous clinical trials has been at the center of discussions regarding the development and validity of COVID-19 vaccines.
However, another issue accompanying these discussions has been affecting the health care landscape for many years: the lack of diversity among the volunteers who participate in clinical trials.
Research has found that although 40% of Americans belong to a racial or ethnic minority, the patients who participate in clinical trials for new drugs are still heavily white, and in some cases, peaking in the 80% to 90% range.1 This has caused an ongoing problem with mistrust in many vaccines and medications, since there is still uncertainty surrounding how they affect other races and ethnicities.
According to Sharlene Brown, PhD, director of Business Development at Jeeva Clinical Trials Inc. despite racial and ethnic minorities comprising up to one-third of the population, industry-sponsored clinical trials primarily consist of white participants.
“A majority of the clinical trials are run in the USA and EU at major metropolitan medical centers to attract participants living closer to these densely populated regions. Most of the people living in these areas tend to be Caucasian males from an affluent background,” Brown said in an interview with Pharmacy Times®.
Brown added that although new technologies and other recruitment strategies have been implemented to counterbalance racial inequities in clinical research, these resources are limited without regulatory guidelines and incentives in place to continue encouraging sponsors to increase patient diversity in clinical trials.
Other than minorities, research has shown that women, children, people living in rural or remote geographic areas, people with LGBTQ+ identities, and indigenous populations are the most underrepresented in trials.1
Brown noted that because regulators have not implemented corrective measures yet, this lack of representation does not impede the pathway to regulatory approval and commercialization.
“Introducing demographic variability during the clinical trial phases will create more data points for each group before the therapy goes to market,” Brown said in an interview with Pharmacy Times®.
“This would be a great benefit to patients with health challenges as their prescribing doctors will have that much more confidence in creating treatment plans when they can rely on representative rather than homogenous clinical data.”
Safety and efficacy are of high importance when evaluating the quality of a new therapy in clinical trials. The ongoing misrepresentation of the real-world patient population restricts the actual safety and efficacy of the therapy to only the patient group studied, questioning the accuracy of the treatment, according to Brown.
Brown added that physicians can interpret clinical trial data well, however, it is rare that they consider data points that are missing because of disparities in socio-economic determinants of health.
“The quality of a new therapy may be high in the studied population but variable or even toxic in another, and neither the prescriber, patient, sponsor, or regulators will be aware of this discrepancy. This is the current model that we must work to improve,” Brown said in an interview with Pharmacy Times®. “For example, a vaccine tested on a diverse population during clinical trials will ensure its safety and effectiveness is suitable for the general population that it’s meant for.”
With more inclusive trials in the future, there can be greater trust between researchers, patients, and health care professionals. Seeing representation in clinical trials among those affected by these conditions will lead to more patients gaining the fullest medical benefit, Brown noted.
Further, a more diverse trial population could lead to higher completion rates and better-quality data. Brown echoed these benefits and the positives of increasing clinical trial inclusion.
“When studies are more inclusive and patient enrollment is up, studies stay on track and rarely terminate due to patient participation. In a way, increasing clinical trial inclusion has advantageous side effects for the patients and clinical trial sponsors,” Brown told Pharmacy Times®. “We can achieve this universally by making genuine and deliberate efforts to recruit study participants that reflect the patients meant to receive the therapy.”
With these improvements, there is a huge opportunity for technology to help solve the issue of low patient recruitment and diversity.
Brown mentioned that removing logistical burdens and maximizing electronic patient data are already assisting in the acceleration of clinical research and can continue to be the “backbone” of these trials.
“Our hope is to see the rapid adoption of human-centric technologies to help improve diversity, equity, and inclusion in clinical trials,” Brown told Pharmacy Times®. “Modernizing clinical trials to support online, remote, and patient-centric protocols is the way forward.”
REFERENCE
Clinical trials have far too little racial and ethnic diversity. Scientific American. September 1, 2018. Accessed August 17, 2021. https://www.scientificamerican.com/article/clinical-trials-have-far-too-little-racial-and-ethnic-diversity/
