Clinical Trial Diversity: What We Learn and What We Do
At Xentria, we recognize that diversity in clinical trials encompasses a broad spectrum of considerations beyond ethnicity and race. These insights shape Xentria’s developmental framework early on in drug development, well in advance of clinical trial design. Driven by a strong desire to listen, learn and adapt, we continuously refine our development process through feedback and collaborative insights from subject matter experts across various indications. This patient-centric approach sets intentions to align our research and development efforts with patient needs.
Our commitment to diversity is integral to our mission to develop accessible treatments that reflect the real-world diversity of the patient populations we aim to serve.
In our ongoing Phase II clinical trial in sarcoidosis, we are developing our lead investigational candidate, XTMAB-16, with a focus on demographic inclusivity and equitable access. A webinar by the Foundation for Sarcoidosis Research noted, “When looking at clinical trials for rare disease specifically, Black Americans only represent 9% of clinical trial participants.” [1] With our chosen clinical trial outcome measures, we aim to address the complexities of rare disease treatment paradigms by incorporating evidence-based assessments that account for disparities related to condition severity, prescribing trends and diverse clinical manifestations.
Comprehensive Diversity Plan
Regardless of indication, we strive to create a multifaceted diversity plan, addressing the nuances of trial inclusion that span from protocol design to patient and site engagement. Before initiating a phase 1 trial, we set out to create transparent dialogue with key opinion leaders, patients and advocacy groups to listen and broaden our understanding of the currently available prevention, screening or diagnostic strategies and treatments through diverse insights.
We place a strong emphasis on collecting data that will support the product’s potential safety and effectiveness. In rare diseases specifically, this affords an opportunity to engage in translational research where exposure-response analyses and modeling can aim to measure the impact that sex, race and ethnicity may have in how the product interacts in the intended patient population. We also never underestimate the need to incorporate patient-reported outcomes that aim to capture the day-to-day impact of an intervention on participants’ lives.
At the time of trial design, we conduct a protocol impact analysis and apply our learnings when critically assessing if certain study requirements might, for example, disproportionately exclude individuals with other conditions unrelated to the primary objectives of the study. This approach ensures that our trials are as open and accessible as possible.
Engagement and Retention Initiatives
Key to our strategy is the integration of clinical trial measures aimed at both engaging and retaining diverse patient populations. This includes reimbursement for travel and lodging, ensuring financial barriers do not hinder participation. The study designs incorporate patient-reported outcomes, aiming to capture the day-to-day impact of an intervention on participants’ lives. Additionally, we create study guides that provide concise information on upcoming visits, reminders and contact details, which we distribute to the clinical trial sites.
We also nurture meaningful connections with patient advocacy groups and outreach to community centers, thereby broadening our engagement beyond traditional research facilities and into the community. Expanding recruitment beyond these traditional facilities can significantly improve the diversity of clinical trial populations. By strategically selecting a mix of channels and collaborators, we are able to formulate a strategy that is both appropriate for the condition and the corresponding patient population. [2]
Advocacy and Community Engagement
Maintaining strong connections with advocacy groups of all sizes and incorporating patient feedback are strategically central to our approach. These relationships help garner thoughtful and helpful feedback that deepens Xentria’s understanding and directly influences how we speak about a disease on our website, in presentations and in daily conversations. We attend conferences and events hosted by advocacy groups to foster direct connections with patients, advocates and physicians who are essential for understanding and addressing the specific conditions we target.
Through site staff training we encourage principal investigators and coordinators to advocate for patients during the consenting process. With these advocacy efforts, we aim to empower patients to make informed decisions about clinical trial participation, recognizing the importance of support networks in this decision-making process. And it is encouraged to include family and friends in these conversations as a key step in a patient’s health journey. This approach facilitates informed discussions, educates about clinical trials and increases patients’ comfort and confidence in participating. [1]
Building Trust Through Transparency and Education
To combat research mistrust and provide clear, understandable study information, we provide our trial sites with talking points that facilitate transparent discussions with potential participants and allow individuals to feel informed about their involvement in the trial.
We develop our study materials with input from key opinion leaders (KOLs), advocacy groups and direct patient engagement, ensuring that our protocols and recruitment materials are shaped by patient listening sessions and centered on their input. We approach these interactions with a genuine curiosity, constantly striving to better understand the role a disease plays in the daily life of a patient, including their perspectives on the most significant symptoms and outcomes they value most.
These collaborative efforts reflect our passion to deliver for patients and utilize key insights to adapt our approach and meet their evolving needs.
Driving Forward with a Representative Focus
Our commitment is to design and execute trials that are not just inclusive but truly representative of the diverse patient populations affected by difficult-to-treat conditions. By tackling the multifaceted barriers to drug development and clinical trial participation, Xentria hopes comprehensive planning and thoughtful implementation contributes towards more accessible, equitable, and impactful clinical research.
[1] Cohen K. Using your voice with clinicians and research. Foundation for Sarcoidosis Research webinar. April 26, 2024. Accessed May 2, 2024. https://www.youtube.com/watch?v=uC81vrZeF84
[2] "Addressing Demographic Disparities in Clinical Trials." Harvard Business Review. https://hbr.org/2021/06/addressing-demographic-disparities-in-clinical-trials Published June 11, 2021. Accessed May 2, 2024.