Though the life sciences industry has committed to improving diversity in clinical trials, there’s still work to be done. Childhood asthma is a case in point.
Clinical Leader noted the widely prescribed asthma drug albuterol, approved by the U.S. Food and Drug Administration (FDA) more than 20 years ago, still performs poorly in children of African and Puerto Rican ancestry. Asthma is prevalent in these populations, but researchers haven’t conducted many trials in communities of color. As a result, the reasons for the drug’s ineffectiveness aren’t clear, and alternatives haven’t yet been identified.
Fortunately, advances in clinical research software are helping researchers analyze digital engagement efforts. Bryan Saxon, Head of Product and Technology for Acclinate, explains that these types of tools offer sponsors two important benefits. One is identifying those who might be most willing to participate in a trial based on how they engage with content online. The other is determining which content drives the most engagement, which is an important step in building affective trust with communities underrepresented in clinical trials.
Clinical researchers are taking multiple steps to make trials more diverse, including the FDA Draft Guidance, backed by mandatory FDORA requirements. Other health equity solutions, as detailed by PharmaVoice, include internal diversity scorecards and community-based partnerships.
Targeted outreach to communities of color is another important step. This can happen in-person or across multiple channels, like engaging with a social media post, watching a video, reading an email or text message, joining a disease-specific online community (like Acclinate’s NOWINCLUDED), and so on. For researchers, the goal is to get individuals who engage with content to complete a prescreening questionnaire and see if they meet inclusion criteria for a clinical trial.
Saxon’s work focuses on e-DICT, Acclinate's analytics platform, providing real-time reporting on community access and engagement activities and insights into potential clinical trial participants. He describes the tool as “a window into the work” sponsors do to communicate about clinical trial opportunities. The clinical research analytics tool has three important functions.
Aggregate data from in-person and omnichannel community engagement activity. Otherwise, data about interactions such as videos, social media posts, and emails must be collected and formatted manually from disparate platforms. That takes time and slows down the engagement process.
Display the results of engagement efforts. Along with drilling down to an individual level, e-DICT lets sponsors see which content worked well and which fell flat. Pulling in qualitative insights from sponsor sites, such as barriers to achieving enrollment goals, provides additional context and further helps researchers more effectively connect with communities.
Assign an individual a participation probability index (PPI) using a proprietary algorithm. Saxon explains that this is a crucial benefit of Acclinate’s e-DICT clinical research software. It helps Acclinate inform sponsors of those who are willing to participate, those who are unsure, and those who are not yet ready – to inform researchers of the next steps and help them to achieve a more strategic, data-driven approach. “We create more of a [funnel] so that researchers more readily know who's willing to participate, and then it's less about trying to get 1,000,000 people to get one participant,” Saxon says. In other words, e-DICT's proprietary PPI score is an efficiency enabler.
Recently, pharmaphorum outlined several ways technology can increase access to and diversity in clinical trials, including faster patient assessments and additional accommodation for remote participants. This is certainly helpful – but it skips the important step of identifying, engaging, and mobilizing trial participants from communities of color in the first place.
The insights available from clinical trial software such as e-DICT empower organizations to not just execute but also plan more diverse trials. Sponsors can see which population subsets in which geographic areas may be willing to participate in a trial, along with which content is most likely to resonate with individuals in that population. The impact of a more diverse clinical trial population is far-reaching. For starters, it specifically addresses the FDA’s diversity action plan requirements, without which the FDA may conduct additional reviews or request further studies, delaying a drug’s approval or perhaps even jeopardizing it. Research has shown additional trials, coupled with additional clinic visits, contribute to significant increases in drug development costs, not to mention further delays in bringing treatments to market.
In addition, diverse trial populations let researchers gain direct evidence of how treatments affect traditionally underrepresented populations. For communities of color who face higher disease prevalence for asthma and Type 2 diabetes, obesity, and certain cancers, this is vital to improving clinical outcomes and addressing longstanding barriers to health equity.
NOWINCLUDED, the community engagement arm of Acclinate, engages people of color both digitally and in-person to build relationships with supportive communities while also learning about the clinical trials and health resources available to them. NOWINCLUDED is built on the foundation of Acclinate’s Affective Trust Framework, a set of principles for leveraging technology and other health equity solutions to build trusting relationships with people of color – based on authenticity and inclusivity.
The clinical trial software features available through e-DICT align with this framework. By analyzing the probability that individuals will be willing to participate in the trial with a PPI score and identifying the types of activities that resonate with individuals likely to participate, researchers are equipped to be more strategic outreach and meet their goals for clinical trial diversity faster and with more efficiency.
Boost inclusivity in trials faster and for the long term by zeroing in on the populations you lack. Acclinate gives you access to communities of color, facilitates engagement around your trials, then analyzes the data generated to predict and plan where and when your next effort should happen to create the ongoing representation you need. To learn more, schedule a 1:1 Meeting.