At DPHARM’s sold out 2022 conference, Inato’s team joined industry thought leaders to explore the latest innovations driving the modernization of clinical research. To a crowded room of pharma leaders, Inato’s Liz Beatty and Otsuka’s Candace Saldarini presented their teams’ findings on how collaborating with community-based research sites enabled accelerated, inclusive clinical trials. These results emerged just a year after Inato and Otsuka launched their first trial together in 2021. Since then, they have collaborated on five trials spanning three countries and over 30 research centers, with an additional 16 now pending. In that time two outstanding trials have already displayed the incredible impact community-based sites can have on improving research outcomes.
Otsuka’s Key Challenges
Otsuka was looking to develop a strategy for boosting site and patient engagement and increase the speed and quality of their trials. To ensure this was a reality, accessibility and inclusivity were a top priority. With a current focus on mental health treatments, Otsuka’s team recognized the critical role a patient’s community plays in medical care, making the decision to keep these patients in familiar environments with physicians they were comfortable with. Saldarini explained, “We really needed to go to the safe and trusted community partners that were delivering care for those patients.” They chose to collaborate with Inato to engage those sites and the communities they serve.
Initial Trial Results: Agitation in Alzheimer’s
The first trial Otsuka came to Inato with was for Agitation in Alzheimer’s dementia. This patient demographic brought about specific challenges as explained by Saldarini, “People in this population, elderly people with caregivers, were particularly affected by the COVID19 pandemic and were hesitant to participate in research.” These challenges drove Otsuka to bring the trials to patients in their communities rather than having patients travel to the trial. Despite the original belief that Florida-based research centers were tapped out for patients, Inato was able to identify eight additional sites with unique patient populations, subsequently diversifying the populations with access to the trial. With just two months to enroll, the community sites were able to activate rapidly with Inato’s support, allowing Otsuka to achieve their enrollment timelines.
Initial Trial Results: Major Depressive Disorder
After the successes in the Alzheimer’s trial, Otsuka joined forces with Inato to accelerate the enrollment of a Major Depressive Disorder study. A crucial part of this trial was the incorporation of digital assets, meaning those who participated were required to be interested in and specifically experienced with the use of technology. This limited Otsuka’s pool of qualified sites and, while the digital nature of this program enabled virtual trials, Saldarini explained that, “[Otsuka] wanted to be involved within the communities that were interested in doing this different kind of work.” By connecting closely with interested sites, just as in the Alzheimer’s trial, Inato committed to providing additional support for the community research centers, ensuring that they activate within the tight time frame. Through setting activation targets ahead of time, Beatty revealed that “[Inato was] able to exceed activation goals with the sites in the community with an average of 6.1 weeks to get activated.” One site was able to pre-screen 12 patients, screen five patients, and enroll two right at the end of enrollment, again pushing Otsuka over the finish line towards their goals.
Learnings and a Look Into the Future
The ongoing communication with sites also allowed Inato’s team to understand the nuances within a diverse community. Beatty outlined these learnings, saying, “Just because you might be in an area where there is a very diverse population, doesn’t mean that those are patients that you see and serve in your community.” It is their involved roles in the community that bring in diverse patients, not simply location. The conversations revealed the individualized ways sites are connecting to their community through outreach, representation on their research teams, or inclusive language and translation offerings. Such outstanding elements of these research centers are what truly grant a vast array of patients the opportunity to participate in global trials and receive care in the comfort of their community.
Across these trials, Otsuka found that the collaboration with community sites allowed them to achieve their research objectives while providing medical innovation to the people who need it most. By bringing trials to the patients where they live, both Otsuka and the sites were able to overcome the limited access hindering the efficiency and inclusivity of the trials. Saldarini said, “These sites are the right fit for the piece of the puzzle that we look for.” The results from these studies provide a promising outlook for the future of clinical research where the inclusion of community-based sites permits diverse, accelerated, and efficient trials.