Praxis: ‘No quick fix’ for increasing clinical trial inclusivity

While the clinical research field appears committed to improving the diversity and representation of its trial patient populations, there does not seem to be a clear and easy path to reaching that goal. Karen Renzi, senior director of strategy with Praxis, spoke with Outsourcing-Pharma about how technology, techniques, and a thoughtful approach might offer solutions.

OSP: The industry has long talked about collective interest in increasing the diversity of their trials. Could you please talk about how clinical research professionals have made progress in delivering in recent years?​

KR: Overall, the increase in awareness of the importance of diversity in clinical trials has been encouraging. We’re seeing a shift where DEI is incorporated into multiple aspects of trial planning, rather than considered as an afterthought. For patient recruitment efforts we have long supported, this is demonstrated through mindful representation and inclusivity in campaign creative, a focus on health literacy in content, and layering on targeting and/or outreach to specific underrepresented populations in campaigns, where appropriate.

What has been a noticeable difference is the number of companies that we’re working with who are actively asking for this approach and the number of companies hiring specific people responsible to ensure this is in place.

OSP: In what ways have they fallen short?​

KR: So many of the barriers to health equity in general, beyond just diversity in trial participation, are systemic and challenging to address with short-term approaches. There is more long-term work to be done to address the root causes of these disparities and that can only benefit from a concerted effort on the part of pharmaceutical and biotech companies, as well as other industry partners.

It may not happen overnight but demonstrating a long-term commitment to supporting the work of groups devoted to addressing DEI issues in healthcare, promoting increased diversity among healthcare professionals, and improving access to healthcare for underrepresented populations will ultimately benefit clinical trial diversity – likely more than any short-term fixes.

OSP: Please talk about some of the ways studies can harness technology (data collection, monitoring, wearables, etc.) to help increase inclusivity​

KR: Technology, and more specifically, data, can potentially help studies better understand the differences between different patient populations they are studying. In the aggregate, this can help to adapt future studies to better fit any unique needs that emerge as learnings. A shift to virtual studies could also help make clinical research an option in underserved locations.

However, it’s important to recognize that technology in and of itself is not a silver bullet for increasing inclusivity, reaching people, or solving problems. The power of human connection and relationships will always come into play.

OSP: Can you think of any ways in which technology can get in the way of reaching patients from underrepresented populations?​

KR: Especially when it comes to technology, we must remember that we cannot treat any given population as monolithic. There will be individual preferences and usage habits within all populations.

When it comes to determining the best ways to reach a given population, the use of technology can be considered as one component of a multi-channel approach. Technology also cannot be expected to overcome some of the deep-rooted feelings of mistrust in healthcare and research that may exist in some underrepresented populations.

Some possible ways technology could “get in the way” of reaching patients from underrepresented populations could include:

• As noted, technology could seem overwhelming to an elderly population, though there will be heavy tech users in any age group.
• Access to technology, including internet/Wi-Fi access (if not provided), could be a barrier to those of lower socioeconomic status or in regions where the internet is not as available in general.
• In addition to access, not everyone will have the latest and greatest computers, mobile devices, tablets, or wearables, so implementing technology that is cross-functional and will work across a variety of platforms (even dated ones), is critical.
• For technology such as apps, or even websites, lack of translations into native languages common among the underrepresented populations can also be a barrier.

OSP: When trial teams evaluate their operations or specific studies for opportunities to increase inclusivity, can you think of some examples of what they should look for?​

KR: Trial teams committed to increasing inclusivity should consider:

• Building in adequate time to gather insights from underrepresented groups (where possible and appropriate) at key milestones of both trial design and campaign development.
• Increasing diversity among the frontline PIs/research staff and locating research sites within communities serving the underrepresented populations they are looking to include.
• Ensuring the patient experience, including all study materials, imagery, and messaging, is developed through a lens focused on inclusivity.
• Training all staff on DEI awareness and setting it as a core internal priority, as well as a priority for research sites.
• Continually tracking diversity in enrollment to monitor whether additional emphasis is needed to reach a certain underrepresented demographic.
• Ensuring that ongoing support via retention efforts continues to promote a positive patient experience in the larger context of improving healthcare perceptions among underrepresented populations.

OSP: How can a company like yours help increase inclusivity?​

KR: At Praxis, we continually focus attention on diversity in study imagery and messaging, and even prior to developing communications, our analytics team can gather insights from underrepresented groups (where possible and appropriate) via primary research. It’s important that we, as a company, along with others in this industry, consider the following:

• If live-action videos are included as part of awareness, we recommend sponsors make efforts to include BIPOC PIs and study team members.
• Many digital paid media tactics offer opportunities to target based on cultural affinity or cultural interests. These segments can be layered into the campaign if our sponsors would like to adjust ad messaging, landing pages, or ensure a portion of the budget is effectively reaching specific groups. If applicable, traditional advertising also offers the opportunity to target cable networks or radio formats reaching a higher concentration of certain demographic groups. 
• Likewise, advocacy and media relations tactics can incorporate a focus on organizations and publications reaching a diverse population and/or those focused on serving minority health initiatives, in an effort to build awareness through those channels when appropriate.
• We recommend sponsors collect data related to race/ethnicity or other relevant demographic factors via their study prescreening in order to effectively measure diversity in participation at the initial trial awareness stage and identify any differences or concerns that may emerge, to enable continued optimization in our joint efforts.

OSP: Do you have anything to add?​

KR: To truly impact diversity in clinical research, this requires a fundamental shift in mindset, first in awareness, and then in commitment to embedding inclusivity efforts in every element of trial planning and execution. There is no quick fix or short-term tactic that will solve this. As an industry, sponsors and their vendor partners need to be aligned and committed to this critical objective for the long term.