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Regulatory compliance, collaboration, and effective use of technology among ways CROs can overcome challenges.
Historically, clinical trial research has focused on participants from predominant populations. A 2020 FDA analysis of global clinical trial participation found, out of 292,537 participants, 76% were white, 11% Asian and 7% Black.1 In addition, LGBTQ+ and individuals with disabilities are among other underrepresented populations. The decentralized clinical trial (DCT) model, whether virtual or hybrid, can help reach previously neglected groups. By understanding best practices, sponsors, and contract research organizations (CROs) can overcome key challenges.
Be an advocate: Every partner and individual working in the clinical trials space can become a voice for diversity and inclusion. For example, within a given geography, consider the demographic composition of ethnic communities and gender identities within it. If 50% of the population is female in the geography of a trial appropriate for that gender, then ensure equitable representation by working toward 50% female clinical trial participation. The result is a more diverse data set reflective of a population’s represented groups and further supports a study’s validity.
Establish a transparent, patient-centric experience: Underrepresented communities have experienced past abuses during clinical trials and other healthcare settings. While current law and ethics efforts, such as Institutional Review Boards (IRB) and informed consent, help ensure patient safety, these communities may feel mistrust that can linger for decades and impact their interest in volunteering for new studies.
Transparency is the foundation for conducting inclusive clinical trials with diverse populations. Be proactive and acknowledge historical abuse. Encourage clinical trial patients to actively engage with community leadership, ask questions and provide feedback to create valuable dialogue. Leaders able to deliver these messages, show vulnerability themselves and convey humility can create a personal connection that can help overcome apprehension.
An experienced consultant who is a member of the community can help build trust and engage underrepresented patients. Working with or establishing a community engagement board (CEB) comprising local healthcare officials and community leaders, sponsors and CROs can also help bridge potential trust gaps.
Ensure the clinical trial team reflects the population: Help underrepresented patients feel more at ease by leveraging a diverse panel of staff and investigators, as patients are more likely to feel comfortable if they see themselves reflected in the staff—including home care nursing teams that are fundamental to some decentralized clinical trials. This can add another layer of trust in terms of understanding that the clinical trial team doing the work has the patient’s best interest in mind. Partnering with community health organizations with a trusted presence in the community can help facilitate diverse staffing. Equally important: hiring a diverse staff advances diversity in the STEM field overall.
Meet patients where they are: DCTs and the technology used to support them can minimize barriers to participation by eliminating the need for patients to spend time visiting clinical trial sites.
However, not every patient in a diverse population is at the same place in their digital journey. Consider a clinical trial that requires the use of a wearable device in a brand a particular population is not familiar with. One patient may be comfortable using an unfamiliar device, while another may find the technology intimidating since it is not a familiar brand.
With respect to the digital journey, be sure to think about the age of patients in the trial. Some older patients will be uneasy with technology, and some will also prefer face-to-face engagement with a healthcare professional—from the perspective of their generation’s characteristics, or possibly social issues such as loneliness.
The inability to access the internet can present barriers for patients challenged with economic disadvantages, a digital divide that can encompasses those in both urban and rural areas. In addition, persistent connectivity issues in economically disadvantaged areas can interrupt patients’ ability to participate. Provisions, such as securing grant funding, may need to be made to extend reliable internet access to participants.
Ensure the technology enhances the patient experience: Technology is fundamental to decentralized clinical trials but ensure it is as simple and intuitive to use as possible. Consider how best to support technology use, whether it is in-person training with a healthcare professional or a step-by-step video guide. Equally, think if equipment can be set up to work out of the box—e.g., a tablet with charge in the battery and the ePRO (electronic Patient Reported Outcome) software already pre-loaded makes for much simpler participation than placing the burden upon the patient to access and download the correct digital platforms and apps.
Infrastructure and logistics: When working with populations in emerging regions, existing infrastructure can present unique challenges. For example, a specific region might be prone to frequent power outages, which can impact refrigerated drugs or patient samples. Local experts can help properly prepare a clinical trial for situations that might not be typical in a study conducted in regions with historically majority populations. Help mitigate risk and create confidence in patient populations by leveraging external and international quality assurance practices.
Consider regulatory compliance: Navigating regulations in emerging regions with often excluded populations can still be a challenge, despite regulatory advances many countries have made in recent years. For example, the regulatory framework can be lengthier or entail more extensive bureaucracy than countries with historically dominant patient populations. To avoid delays that can potentially impact community trust, start working—during protocol development—with investigators who have expertise in working in areas with underrepresented populations.
Consider accessibility a necessity: Clinical trial participation can present significant barriers for people living with disabilities, yet technologies and processes can support equitable access and inclusion for these populations. Design clinical trial-related content, like patient instructions or reminders, to work with assistive technologies, like screen readers, while options like telehealth or home healthcare professionals can support participants living with mobility challenges.
Collaborate with partners committed to clinical trial diversity: Another step toward building equitable clinical trials is to establish diversity and inclusion benchmarks for clinical trial best practices. Organizations with expertise in the field can provide the support, guidance and resources to clinical trials that are more representative of real-world populations. Look also for industry partners, from CROs to suppliers, who emphasize diversity in their own organizations and reflect that mindset in the work they do.
We often hear of “patient centricity,” in clinical trials being key for patient recruitment and retention; having diversity built into clinical trials works towards these tenets of a successful study.
Additionally, when clinical trials embrace diversity, our critical work better reflects real-world populations, develops a clearer picture of overall health and well-being, and identifies further opportunities for healthcare advancements. Putting diversity into action also helps us understand differences in geography, populations, demographics, etc., as it relates not just to medical research but how that can be applied to advance health equity and move science forward across the globe.
Noël France, vice president, diversity, equity, and inclusion, Claudia Berrón, senior vice president, clinical services, and Mac Winslow, senior director, global customer development, clinical services; all with Avantor