Why improving diversity, equity, and inclusion in clinical trials should be a research priority

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Disparities related to diversity, equity, and inclusion (DEI) are common and well-known in clinical trials. It is well-documented that racial minorities, underprivileged, and non-white ethnic groups are much less represented in clinical trials. Historically, the numbers of clinical trial participants from diverse populations have not reflected real-world populations. Minorities often underrepresented in clinical trials include women, members of the LGBTQ+ community, indigenous populations, older adults, native Americans, pediatric patients, and people living in hard-to-reach geographies. 

In the United States, socio-economic and geographic divides persistently limit patient diversity in clinical trials. As a result, we have only partial understanding of how safe and effective therapies are when they launch. Without diverse communities, researchers run the risk of making assumptions about drug safety and effectiveness that may not be accurate. There is a need to increase participation and retention among diverse patients who may otherwise not be invited to participate in clinical trials for new drug development. Not only would these measures provide pivotal data for a variety of backgrounds, but it would also provide these study participants with first access to new precision therapies at no cost, a privilege of the few. 

Why are inclusive clinical trials important? 

Addressing the challenges of diversity, equity and inclusion in clinical trials is important because there are many occurrences when drugs behaved differently from one population to another. Failing to understand these differences at the clinical trial stage, in which patients are monitored most closely, could result in suboptimal drug efficacy and potentially avoidable safety issues due to overexposure and underexposure to the drugs in many future patients. Having representative patient populations in clinical trials helps ensure the safety and effectiveness of therapies for everyone. 

How to increase diversity, equity and inclusion in clinical trials 

Do not select a site merely because of familiarity or convenience, especially if these sites have no demonstrable reach in that community beyond their location. Clinical trial sites should include locations with a higher concentration of racial and ethnic minority patients. Factor in relevant disease prevalence data in those areas when designing protocols or planning recruitment initiatives. 

Do not treat Black and Brown communities as monolithic groups that have the same life experiences. Do not set people of color into shallow narratives and stereotypes, such as Black people can only be reached through the church. Similarly, defaulting to do business with majority-owned (read: White) firms simply because they are familiar, and you feel comfortable to communicate and connect with them is not the right practice. 

It is important to carefully examine exclusion and inclusion criteria to ensure they are necessary to achieve study objectives and that they do not pose an unnecessary barrier for would-be enrollees. When possible, reducing the frequency of study visits, collaborative strategies, expanded access, flexibility in visit windows, and electronic communication tools should be employed to make trials more inclusive. Clinical trial participation should be made less burdensome for the volunteers and caregivers. 

Legal frameworks and recent initiatives to improve diversity and inclusion in clinical trials 

Improvements in DEI initiatives have of late come from recognition by drug developers, lawmakers, sponsors, patient advocates and regulatory authorities of the importance of DEI in clinical trials, and how sociocultural variables reverberate in clinical research. In reality, the void in diversity, equity and inclusion in clinical trials and research is an old problem as it only represents a disproportional disease burden. What is unprecedented is the widespread attention that diversity, equity and inclusion has gotten in clinical trials recently. The fierce urgency to develop effective coronavirus solutions means that these inequities in clinical trials are finally getting the attention long needed. 

Indeed, there is a need to address the issues of diversity, equity, and inclusion in clinical trials if innovators are to fulfill their promise of precision medicines for each individual. Information flow, data sharing, and reducing the logistical burden to participate are high-priority areas to improve access for underrepresented populations. This is also true in research laboratories where the greater the diversity of the participating patient population, the higher the chances that certain breakthroughs from clinical trials may be achieved

Overcoming barriers and achieving DEI in clinical trials with technology

Systematic change in how we approach the issue of diversity, equity and inclusion in clinical trials is needed for the real clinical trial diversity to transpire. The Jeeva eClinical Cloud (Jeeva) is a modular Software as a Service (SaaS) subscription model that is designed to help a clinical study’s annual budget on a simple per participant basis, while ensuring that the study participants are truly represented to include diversity, equity, and inclusion. The platform has many features such as eConsent, pre-screening, automated enrollment workflow, adverse event reporting and more to maximize diversity, equity, and inclusion for the participants, such as women and minorities that are less likely to participate in clinical trials due to logistical burdens and special needs such as childcare, transportation and loss of pay. 

Walking the talk of patient-centricity 

Jeeva considers patients as critical partners, not merely subjects of study, and walks the talk of patient-centricity. The cloud platform incorporates patient voices early during clinical trial protocol development and logistical planning. Jeeva believes that humanizing the workflows leaves room for humanizing the patient experience, and creates an atmosphere of trust, especially among the communities of color and ethnic minorities that have traditionally been underrepresented in studies. Jeeva is developed by researchers with empathy who listen to help clinical researchers, hospitals, academia, CROs and biopharmaceutical sponsors to address the issues of diversity, equity and inclusion in clinical trials, and accelerate patient recruitment by three times faster. 

Minimizing regulatory risk and maximizing compliance 

Jeeva’s bring your own device (BYOD) platform makes it easy for study investigators to onboard, retain and engage participants with an appropriate focus on diversity, equity, and inclusion. Jeeva’s experienced coordinators are trained to manage trial operations to minimize burden, reduce dropouts, and improve compliance meeting regulatory requirements at various levels, such as Good Clinical Practice (GCP) guideline by the international code of harmonization (ICH), human subjects protection guidelines, data protection guidelines such as GDPR, and institutional review boards (IRBs) that help in accelerating the development of therapies. 

The platform is designed to enhance geographic and demographic diversity and reduces 70% burden on study teams and participants to collect data that are representative of the population. Jeeva supports multi-site studies with centralized monitoring dashboard, and centralized study management & monitoring. 

As researchers seek to accelerate regulatory approvals, Jeeva eClinical SaaS can help achieve this goal while also increasing diversity, equity, and inclusion in clinical trials by enabling wider access to participants irrespective of their zipcode.

Posted in Blog, Patient Diversity.

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