As the Clinical Trial space shifts to recover from the impact of COVID-19 and adjust to a new, more patient-centric world, community-based sites have become even more important. These sites can act as the voice of the patient, providing vital insights to pharmaceutical sponsors and acting as a critical partner when addressing some of the largest challenges facing the industry today.
During a live webinar on Wednesday, May 5, sponsor leaders shared their experiences working with community sites and how it has helped them increase enrollment speed, navigate the challenges brought on by the pandemic, and identify new approaches to engage with patients.
How to combat increased competition
Universally, the leaders all faced challenges with competition, both internal and external. Amy Froment, Head of Global Trial Optimization at Regeneron, spoke to the increasing competition she and her team have faced and why it’s so important for sponsors to play a role in bringing new researchers into clinical research.
“We need to think about how we can support inexperienced or research-naive sites to be able to participate in research and become our partners as they grow,” Froment said. “That’s something Regeron is beginning to look at this year”
Rosanne Petros, Associate Director of Clinical Trial Operations, at Merck shared that her team is also focusing on how they can help sites. She has also seen a spike in competition, especially with COVID-19. To combat this, she said they’re now seeing a 10-20% rate of new-to-Merck sites in many of their trials.
Coming from a smaller sponsor, Nathalie Riebel, Vice President of Clinical Operations at PDS Biotech, added that her team often felt a kinship to community sites and they were able to form mutually beneficial relationships.
“Especially in oncology, we see that a lot of the studies are conducted at the same sites,” Riebel said. “One investigator could be running 10-15 trials in one tumor area, which is really difficult for smaller sponsors.”
In an effort to become a known entity in a crowded space, Riebel said she has found it really helpful to work with community sites who are also looking to gain recognition.
Is a data-driven approach the best way to identify capable sites?
All three leaders agreed that there are still challenges surrounding identifying sites that are capable of performing well in their studies, especially when sites have limited experience.
“It’s an interesting aspect of some of the work we do with community trials,” said Liz Beatty, Chief Strategy Officer at Inato and moderator of Wednesday’s panel. “ We look to understand what the sites have from a direct study competition perspective and what they need to do to make sure they have the staff available and ready to take on new opportunities for other disease areas that may be represented at their site.”
Petros shared that her team is very data-driven when looking at studies and that they have also used census data for a while now to identify target patient populations. When considering working with new sites, she said enthusiasm goes a long way.
Riebel countered that a strictly data-driven approach can be hard for smaller sponsors with limited resources and lack of access to the large databases. Falling somewhere in between, Froment said Regeneron has been growing and evolving their data strategy to include new sources. This has had an impact on their site targeting and selection as well. She shared that the use of disease-level data is helping to surface community sites much more than previous approaches.
“Rather than focusing on where research has occurred previously, we’re looking at where patients are being treated and then targeting our site identification based on the volumes of the patients,” Froment said. “That then makes it more fair, really, in that we’re looking at our sites in terms of where the patients can access the study.”
Petros said this approach has also helped her team reach their diversity and inclusion goals. “We’ve gotten up to 44% in our US vaccine studies for diverse enrollment,” she said. “That was huge and a lot of it is going to sites and looking at where the patients are.”
Riebel shared that building a strong relationship with sites and speaking with them 1:1 can also help speed up enrollment timelines. At PDS, they have a 15-point touchpoint strategy to work with sites on patient engagement. However, Froment pointed out that there are cases where speeding up enrollment isn’t feasible. In this case, she relies on predictability.
“Speeding up enrollment is not always possible when we’re dealing with rare disease or very complex protocols, but being able to predict that enrollment more accurately and being able to manage expectations around the barriers to engaging and retaining patients will minimize those downstream enrollment delays,” Fromont said.
How close relationships with sites helped sponsors get through the pandemic
Engaging and retaining patients was one of the most urgent issues these sponsors faced during the pandemic. Petros shared that her team shifted to a much more patient-centric approach in order to keep their studies moving forward. “COVID really pushed us into that space because we wanted to retain our patients and continue enrolling,” she said.
At PDS, they made the difficult decision to pause their trials early in the pandemic, a choice made largely based on feedback they received from sites. “We were in constant conversations with the sites trying to understand what they were going through, where their resources were being used and asking for their advice on how they’d be able to open the trial,” Riebel said.
Of course, initially the decision to pause the trials delayed their advancements, but ultimately, Reibel said it paid off and had a clear positive impact on their site engagement.
“The sites felt heard and listened to,” she said. “When we did restart, they helped us to have a fast restart and really pick-up where we left off to give us a new baseline and really commit to this trial.”
Froment saw similar positive results by listening to sites and truly understanding what they need. “What we saw during covid is that feasibility doesn’t need to be slow,” she said. “Sites can be incredibly responsive and fast in terms of engaging for studies.”
All three leaders agreed that these new practices were here to stay. To learn more about engaging with community-based research sites for your next trial, reach out to Inato today.