Introduction
The way we conduct clinical research has significantly changed in recent years. A spate of novel therapies has delivered new hope for patients with life-threatening diseases. Recognition of longstanding health inequities has upended the way we think about trial populations and patient engagement. Digital health and technology have introduced a myriad of new ways to conduct trials, monitor disease progression, and capture endpoints more meaningful to patients than traditional measures. But at the same time, our industry is faced with a series of challenges that hinders the progress of drug development and health equity.
Discussion on these topics at recent conferences such as SCRS Global Site Summit and CRAACO has provided a forum for broader perspectives on how to solve these big issues and also signals an expanding role for the investigator site.
What is the best way to attract diverse communities? What are the best solutions for the data and technology systems challenges? How do we collaborate more efficiently across the clinical research network of stakeholders? How can we rapidly train and support newly qualified staff to meet the demands of research volume and complexity? Read our three-part series on the biggest opportunities and challenges in the site-centric future of clinical research for a synthesis of expert perspectives and suggested solutions for improving clinical trial diversity, operational challenges, and talent demands.
Part 1 – Attracting Diverse Communities
If there’s one thing we can all agree on in clinical research – it’s that patient accrual is hard and becoming even more challenging with more restrictive eligibility criteria, the rise of precision medicine, and the regulatory mandates for diverse trial populations that better represent the disease population.
We also know that attracting diverse communities to research participation is not simply casting a wider net at the recruitment stage, and successful efforts take a village. The clinical research village involves sponsors, CROs, sites, service providers, patient advocacy, and representatives from local communities, including physicians, religious organizations, and community or social service groups. Most important, the process of attracting more diverse populations is a long one that requires investment, collaboration, and patience to educate, build trust and engage new patient groups. In this article, I share insights on the essential building blocks of this process that I’ve gleaned from industry colleagues and successful experiences here at Alcanza.
Education
While the COVID pandemic increased awareness of clinical research among the general public, especially among underrepresented communities, clinical trials can still be perceived as a last resort option for disease progression. This is intrinsically linked to low levels of health literacy across all U.S. adults, even those with high levels of education. Building on the success of COVID vaccine clinical trials, targeted educational campaigns are critical to helping broader audiences understand the benefits of clinical research and how they can be an alternative to the standard of care as a treatment option. There is greater recognition that clinical trials are another healthcare tool, but we need to broaden this awareness. As organizations like CVS, Walgreens, and Walmart enter the clinical research space, there’s a real opportunity to create change.
Big pharma is well-resourced, and we’ll continue to look to sponsors for national educational campaign funding, healthcare provider training, and resource support. Sites can provide a critical role of the known trusted partner in helping to communicate and reinforce educational objectives with local patient communities.
Community Engagement
Community-engaged research is a must-have to build authentic relationships and advance health equity, especially for disease areas known to have a disproportionate representation of underserved populations. Disease-specific strategies for specific communities should be informed by pre-engagement exploration with patient advocacy and community groups before asking for research participation.
These strategies rely on sites to execute a micro-personalized approach for reaching and connecting the geographical and demographic, and cultural characteristics of the disease population. At Alcanza, we have a dedicated role for community outreach, whose remit is focused on finding connections with local community leaders, physician practices, social groups, recreational organizations, and other community health partners. We also host educational health events at many sites to introduce research as a care option to different communities.
On a broader level, there are many emerging community-based research models for complex diseases worth watching, including:
Inflammatory bowel diseases are on the rise among minority populations. IBD Plexus is a new model built as a resource for research communities that enables both research and care for the high unmet needs of patients with inflammatory bowel disease. IBD Plexus® provides access to data and biosamples across research initiatives from a single point by using a technology platform to capture, organize, and share large amounts of data on individuals with IBD and to link and mine this data for insights into causes and treatments. Patients consent to share medical records in a central information exchange. By incorporating the voice of patients with claims and EHR data, this model is a best practice for building trust and facilitating clinical research and real-world evidence in everyday practices.
Lupus, which is more common and severe in African Americans, has been the focus of many community education and engagement programs. Lupus Therapeutics, the clinical research arm of Lupus Research Alliance, engages patients through community-driven programs. The recently announced Project CHANGE is a community-based participatory research approach that leverages healthcare systems, community-based, faith-based, grassroots organizations, and community leaders to tailor action plans to fit each community’s specific and unique needs. Common program elements include patient and physician surveys and medical science liaisons to provide patient support resources for sites.
Big pharma organizations such as Pfizer, Janssen, and Merck have demonstrated at recent conferences how they are building effective models through collaborative efforts with a range of organizations from local food banks, non-profits, and health systems to enhance diverse patient access.
Co-creation
Co-creation is a best practice of patient engagement and inclusive clinical research practices for many reasons. At a basic level, the co-creation of patient-facing materials is the easiest way to ensure that educational, trial recruitment, and other reference materials are developed in a way that will resonate with the target audience. It also builds trust through shared decision-making. Simple, impactful changes may include photo choices that depict the target audience’s activities or represent the disease population’s symptoms. Any language crafted without review by patients or community groups is almost always too medical or full of jargon to avoid confusion.
Co-creation of protocol design allows patients to prioritize what’s important to them and moves the industry away from outdated and harmful practices of cut-and-paste protocols that exclude or introduce unnecessary burdens.
Organizations such as Sanofi, Janssen, and BMS have presented extensively on their co-creation efforts through partnerships with groups like the National Association of Black Nurses and the Black Cancer Collaborative.
Improved Access and Convenience
There are many known burdens of clinical trial participation. The FDA’s recent draft guidance on diversity plans includes a section for reducing the participation burden in its recommended framework that includes transportation assistance, disability accommodations, language assistance, and other methods to make trial participation easier.
At Alcanza, we aim to reduce traditional barriers to participation through extended clinic hours and community health events, as well as a focus on bi-lingual staff and community involvement. When the community knows who you are, what you do, and why you do it, that knowledge and familiarity provide another step toward building trust. We also continually look for ways to be more patient-friendly and modify our practices to support the needs of the patients in the communities we serve.
The desire to improve access and convenience breed continual innovation. During COVID, sponsors such as Lilly, Merck, Pfizer, and others created mobile vans to support COVID studies in under-represented communities and nursing homes.
Within certain therapeutic areas, bringing non-research physicians into clinical research supports the development of new investigators in underserved communities. Most importantly, it can provide a trusted bridge for expanded clinical trial participation.
Why Equitable Research is Necessary
As an industry, we are only beginning to solve inequities in research. Important discussions at CRAACO reminded us there’s nothing biological about racial differences. 80% of health outcomes are believed to be socially driven. Understanding the lived experience and changing social factors to reduce health disparities is more important than ever.
Author: Matthew Maxwell, Chief Marketing Officer
