Behind the term is NC-based Javara, which made its official debut in June 2018. The company’s CEO Jennifer Byrne told us the name ‘integrated research organization,’ or IRO, emerged as the descriptor for the new clinical research model following discussions with Wake Forest Baptist Health.
The goal of the partnership, which continues today, is to do a better job of connecting clinical trial options to more patients – integrating research with care.
“As we were exploring ways in which we could design a more relevant and sustainable business and partnership model together with health care organizations, interconnectivity through the integration of research within the continuum of care would be absolutely essential in building a more effective approach,” Byrne said.
While health systems often have many of the necessary ‘pieces and parts’ to conduct research, siloed departments have made it difficult to work effectively and efficiently. Conversely, Byrne’s vision is for participating health care organizations to make enterprise-wide commitments to the offering of research, no longer limiting trial access to within ‘the bricks and mortar’ of any specific department, but instead, across the whole health care organization.
“Our health care partners are making a business commitment, but also a philosophical commitment, that we are going to leverage our collective resources and assets to extend clinal research as a care option to all patients across the enterprise,” said Byrne. “That’s a monumental shift.”
So, it’s ‘not just a branding term,’ she said, as the process of achieving this requires integration and connectivity between different partners, technology, and other disparate assets across this continuum.
“Too often, when we ‘disrupt’ clinical trials, we actually end up disrupting the patient”
“Our model allows health care physicians an opportunity to bring clinical research directly to their patients while maintaining the integrity of the trusted patient and physician relationship,” said John Potthoff, PhD, CEO of Elligo Health Research.
“We believe that all patients should have the best access to clinical research as a care option. Too often, when we ‘disrupt’ clinical trials, we actually end up disrupting the patient,” Potthoff told us, explaining that by connecting physicians and patients to research “we’re able to provide them research as a care option while maintaining their trusted relationship and allowing for less disruption of their daily lives.”
Irfan Khan, MD, CEO of Circuit Clinical, said the primary opportunity for the IRO model is its ability to addresses the challenges of ‘participant scarcity’ and an aging investigator pool. “We need a new generation of physicians to take up the mantle of clinical research. Equally, we need new people willing to consider participating in clinical trials,” he told us.
The IROs ‘specialty’ is solving these two problems at once. Said Khan, “It’s great that we have established site networks and dedicated research sites, but the patients are in the health systems – only a fraction of which have organized their research programs.”
Getting industry leaders to rethink the experienced investigator
For Javara, the greatest challenge looking over the past 14 months was not unanticipated – though the magnitude perhaps underestimated. The challenge, echoed by both Khan and Potthoff, was, and is, the lack of experienced investigators.
“We are moving into areas of organizations whereby there are a lot of physicians who have not had research experience,” said Byrne. “The inclusion of only experienced investigators in trials is something we must challenge industry leaders to rethink if we can truly be successful in widening the reach to more trial volunteers and physicians.”
The IRO model is the ‘natural response’ to this challenge, Khan said. Specifically, it is an answer to the reality that “too much research is done in too few centers and that fact causes a major chokepoint in the approval of new medicines.”
“Traditionally sponsors have chosen to rely on these trusted sites – academic centers as well as professional dedicated research companies and networks – because they had both infrastructure and motivated, experienced principal investigators,” added Khan, noting that there are not enough of these sites, which is ‘at the heart’ of the industry’s patient recruitment problem.
Still, over the last four years the biggest challenge for Circuit Clinical has been getting sponsors and CROs comfortable with the new model. Explained Khan, “The data models of feasibility strongly bias towards prior research experience – which reinforces the advantages of existing sites over potentially effective new sites.”
The IRO’s time in the sun
Another challenge, according to Potthoff, is ensuring the protocols are designed to match real-world health care practice to facilitate enrollment and align with US Food and Drug Administration (FDA) objectives. He also echoed the workforce challenges, citing the need to ensure physicians have the tools “to manage the complex infrastructure for clinical trials – which is not their core competency.”
Despite all of this, though, Khan said IROs are ‘having their time in the sun,’ as sponsors and CROs over the last two years have looked for new ways to create research sites. The “natural ally of high functioning CROs,” Khan noted that the role of an IRO isn’t to disintermediate a CRO.
“In those cases where sponsors have chosen to handle the CRO functions in-house, they then benefit directly from the distinct value the IRO brings, namely new sites, new patients and new, younger investigators,” he explained.
Similarly to what a CRO does for a pharmaceutical company, is what an IRO can do for a health care organization, echoed Bryne.
“Could the health organization conduct research on their own? Absolutely. Do they do it well on their own? In many cases, from a quantity and business results standpoint, no, not at all.”
“One specific goal with our health care partners conducting industry-sponsored clinical trials is for a scaled offering to result in positive cash flow associated with research activities,” Byrne added, explaining that the company helps minimizes the risk associated with clinical trials programs by building a ‘turnkey’ infrastructure and providing a dedicated research workforce.
As part of this, the company employs clinical trial navigators, as opposed to clinical research coordinators (CRCs). The term ‘navigator’ is a contemporary term within the value-based health care system, and by its definition, involves removing barriers for patients.
“[Clinical trial navigators] do all the things that the traditional CRC does and also are responsible for ensuring the continuity of care for every patient volunteer,” said Byrne. This involves making sure all data and insights are in the EHR, that other physicians within a patient’s care circle are informed, among other tasks – before, during, and after a clinical trial.
Growing up in the digital era
The role of technology varies from IRO to IRO, said Khan. While some focus on providing an end-to-end data collection solution, others, including Circuit Clinical take the “as-digital-as-possible” approach, but outsource with partners for those services, he said.
“In turn we think the most interesting data space yet to be fully realized is patient experience data – and in particular how creating a patient-facing platform is the best way to change the way patients think about their clinical research options,” Khan explained.
“By maximizing novel clinical research technology, we can leverage electronic health records to identify health care physicians and their patients who are able to participate in clinical research that otherwise would not have access,” added Potthoff.
At Javara, the company is white labeling some technology, Byrne said, creating a highly customized stack to augment its health care partners’ electronic health record and other data assets.
Javara’s model is focused on a partnership/services model and not “in any way shape or form strategizing to monetize the data resources for which we access directly or indirectly from our health care partners,” she explained.
Overall, IROs have more open to technology than traditional dedicated clinical research facilities, said Kahn, adding, “This is likely due to the fact IROs grew up in the digital era and don’t have the legacy of paper to deal with.”
Moving forward in this new era, Byrne said the fact that Elligo and Circuit Clinical have pivoted to adopting the IRO descriptor is a “real sign of promise for the validity of the IRO model.” Many of the most successful CROs have learned from each other and had opportunities to collaborate, she said, and so, hopefully, will IROs collaborate and share insights as this new sector grows.