Pharma companies have traditionally relied on the same large academic centers to run their clinical trials, with the top 5% of research sites accounting for about 70% of trials.
There are hundreds of community sites around the world that are looking to offer more trials to their patients, according to executives at startup Inato. Six years ago, the Paris-based company set out to build a platform to help expand the pool of patients for clinical trials.
The goal is to enable hospitals and experienced research sites outside of the top 5% to access trial opportunities with global sponsors and self-select the ones that are best for them. Essentially, Inato wanted to reach the 90% of sites that are generally ignored in clinical research, according to Inato co-founder and CEO Kourosh Davarpanah.
The platform also matches pharma companies with a broader range of research sites to access previously untapped patient populations.
The company grew rapidly in 2021, adding more than 1,200 community-based research sites to its network spanning more than 40 countries and covering over 70 disease areas. The company has also formed key commercial partnerships with more than half a dozen of the top 30 global pharmaceutical companies.
Inato grew global community site adoption of its platform by more than 120% year over year, Davarpanah said. And the company boasts nearly 210% year-over-year growth in pharmaceutical sponsor adoption.
"The whole idea of Inato since the beginning was that the way pharma companies are partnering with doctors is broken because they are leaving out the vast majority of patients," he said in an interview. "If you're a patient, the most important component in joining a trial is the trusted relationship that you have with your doctor because it's not simply about, 'What are the trials out there?' It's about understanding what is the right trial for me. You have to have the doctor in the equation to understand this properly."
Two years ago, Inato pivoted its focus to decentralizing clinical research by enabling community-based investigators to bring the right trials to their patients. "What we've created is an experience where instead of as a site waiting for pharma companies to reach out to you with random trials, you could actually join the platform and get access to all the studies of our pharma company partners in one place," Davarpanah said.
Inato's continued strong growth is proof that trial sponsors are willing to think about access in a more patient-centric way by bringing trials into communities, he noted.
"This is a critical shift for research sites across all levels of experience that have been eagerly awaiting new opportunities to engage in research and bring medical innovations to the people they serve,” he said.
Inato’s platform allows sites to review upcoming trial opportunities and apply for the ones that are the best fit for them and their patients.
The company has developed a new tool to streamline trial matching with pharma sponsors and reduce redundancies in the trial enrollment process. Inato's "Check Your Fit" tool allows sites to take a two-minute assessment to see whether they are a good match for a specific trial, Davarpanah said. This helps sites avoid wasted time advancing with a clinical trial opportunity that may not be right for their organization or community of patients.
Clinical Trials Management Services recently signed on to Inato's site network to gain access to more clinical trial opportunities and streamline the site selection process with a clear understanding of study protocol goals and requirements, said Teresa Tocher, director of clinical research at the California-based research site.
"I find that the most challenging part of lining up clinical trials is our lack of awareness of available studies in our area. Oftentimes, when we try connecting directly with sponsor/CRO companies looking for new opportunities, there is little to no response. I have spent countless hours online completing site information forms within sponsor/CRO direct websites and rarely get any information back," she said in an interview.
The organization is experienced in conducting trials in all study phases, both inpatient and outpatient with a particular focus on adult clinical trials in internal medicine, vaccines, women’s health, gastroenterology and infectious disease, according to Tocher.
The lack of diversity in clinical trials is a critical problem facing the pharma industry, and broadening access to community-based research sites can help address it, executives said.
Clinical Trials Management Services has a patient database made up of 50% racially and ethnically diverse populations, Tocher said.
"We are a diverse group from various ethnic backgrounds that are fluent in languages such as English, Spanish, Hindi and Telugu. This is encouraging for underrepresented populations as it ensures their understanding of the studies that they are participating in, as it can clearly be explained to them in their native language," she said.
She added, "In order to expand the outreach of clinical trials, our site takes the time to educate our community. Our outreach efforts include things like therapeutic-specific talks from our doctors and staff at local neighborhood centers, print advertisements and social media content for disease areas in which we are aiming to raise awareness. This method gives us an overall advantage when recruiting and conducting clinical trials."
Tocher noted that Inato's latest platform enhancements enable sites to easily determine whether they are a good fit for a study in less time.
Davarpanah points to recent regulatory guidance and pending legislation—such as the Diverse and Equitable Participation in Clinical Trials (DEPICT) Act—that further reinforces the critical need to improve both access and diversity in clinical trials.
To date, Inato sites have already exceeded expectations in ongoing trials, company executives said. For example, Inato site enrollment rates are more than five times higher than non-Inato sites. Also, Inato sites have diversity enrollment rates that are more than two times higher than non-Inato sites.
Two years ago, Inato raised $14 million in a series A round backed by Obvious Ventures, Cathay Innovation, Serena and Fly Ventures.
Davarpanah said Inato is actively fundraising and expects to close its funding round by the end of the year.
Inato will use the fresh cash to fuel its growth with an eye toward reaching 10,000 research sites and expanding the number of clinical trials.
"From a product perspective, we are leveraging all the data that we are now supporting in the platform to be able to improve the reliability of the site recommendation. To put it simply, the more data, the more sites we have active on the platform, the better we become for pharma companies at recommending the sites that are really good at performing, and the better we become for sites recommending the right trial for them," he said.