Last week, at a Marcus Evans webinar, site and sponsor leaders held a virtual discussion considering innovative approaches to establishing a more inclusive future of clinical trials. Restrained by age-old industry norms, modern clinical trials still have a ways to go in terms of representation and accessibility. Nonetheless, leaders in clinical research are eager to shift towards a future where diverse clinical trials are the industry standard.
During the discussion, Christopher Zomerfeld and Alan Zanich, delivered their honest insights into the limitations within the clinical trial industry. Zomerfeld, owner of the Great Lakes Research Institute, suggested new approaches from the perspective of community sites while Zanich, Operational Design Lead at EMD Serono, shared how sponsors are working to increase involvement with community sites.
Inato’s Head of Account Management and webinar moderator, Chris Kreitel, kicked off the discussion directing the conversation towards challenges around site selection and the strategies that sites and sponsors are utilizing to resolve these challenges. Zomerfeld explained that first and foremost, his site ensures that the sponsor has confidence in their capabilities. Given the historical standard of sponsors working with large, academic centers, there is a level of trust that must be established in order for the sponsor to move forward with community sites. Recognizing that it is a more hands-on approach for sponsors to choose smaller, community sites over academic ones, Zomerfeld’s team provides the sponsor with evidence to prove they are capable of executing the trial.
Zanich corroborated that, “community sites can open doors to our target populations and to access diverse patient populations that the academic centers don’t traditionally serve for sponsors,” so if they can provide evidence of access to an underrepresented community, it’s reassuring to the sponsor. However, proximity to a diverse community doesn’t necessarily equate to ease of recruiting these populations. Sponsors are understanding that the benefit of working with community sites is their established presence in the community.
The Great Lakes Research Institute is a step ahead of this notion, proving how successful a community site is when woven in as a working part of the surrounding area. Zomerfeld highlighted the importance of having a staff reflective of the patient population, saying “when you have people directly connected to the community, the community really responds to that.” If a research site with primarily white staff, for example, attempts to recruit patients in communities made up of people of color, there’s a barrier of trust due to the historical trend of mistreatment and exclusion in the medical field. It’s a different story if a research site hires from within the community. “The patient has to feel comfortable with the staff and know that we aren’t just talking, that we truly do care about the patient population and giving back to it,” explained Zomerfeld.
That being said, it’s vital that the sponsor assist sites in working with their community. In Zomerfeld’s community some patients lack proper transportation, the flexibility to leave work, or the ability to purchase meals around the research site. Sponsors that take these situations into consideration and provide stipends and travel assistance can contribute to increased patient retention and, ultimately, better results in their studies.
When discussing the importance of communicating needs, Zanich said, “being transparent early is really, really helpful.” Understanding which protocol requests are unreasonable and what is realistic for community research centers is necessary as sponsors shift from working with large academic sites to smaller sites. There are any number of concerns patients may have that wouldn’t cross the minds of sponsors designing the trial. Though working this closely with community sites can potentially add extra work in designing a study protocol, Zanich reiterated that including these sites is crucial in clinical research, saying “it takes a lot more discussion up front but it’s worth it.” Diverse staff and involvement with the community means smaller sites have access to patients that the sponsors otherwise wouldn’t, and they have the mechanisms to recruit these patients.
Zomerfeld described how his site recruited underrepresented patients based on their established line of trust between the site and the community. His site has access to local organizations that work with the community, for example the personal connection one PI had with a local Sickle Cell Anemia organization allowed them to easily hit enrollment numbers on a Sickle Cell trial. Another trial required high numbers of Native Americans. The Great Lakes Research Site’s existing involvement with the community meant they already knew local tribal leaders and had the ability to recruit the otherwise highly underrepresented demographic for the trial.
A major element of this community involvement is having an engaged PI. Zomerfeld said his site’s PI loves to connect with the patients; his interest in clinical research stems from how much he cares about the well being of the community. He has the ability to get his patients excited about their involvement with the trial. “When you have a talkative, engaged PI the patient is going to think, ‘This is something I want to be involved in,’” Zomerfeld said. The relationship between the Great Lakes Research Institute’s PI and patients proves once again the incomparable ability for community sites to change the game in clinical research.
With the involvement of community sites in major clinical research developing as a pressing necessity, the exclusion of small research centers is no longer an option. As more sponsors begin to understand the unique needs of community sites, and as small research centers develop a comfort in communicating their needs with sponsors, a shift will emerge in the future of research. It takes changes on both ends to move towards the direction of diverse, inclusive clinical trials but, as Alan Zanich and Christopher Zomerfeld showed during the webinar, the desire to change is there.
Inato is committed to improving clinical trial access for all patients. By working closely with both large, global sponsors and qualified, community sites, we’re bridging the gap in clinical research and making trials more accessible and inclusive.