How did Javara get started and what is its mission?
Several of us had the opportunity to work together and understand the potential value of clinical research as part of value-based healthcare organizations, and we deeply believed there was a significant opportunity to help systems realize this value. The initial founders came together to establish a service offering to major healthcare organizations and academic health systems to bring forth a degree of clinical research relevance that addresses the needs of patients while also supporting a paradigm shift to achieve a more reliable drug development pathway.
Our mission is to partner with leading health systems to integrate research into care delivery. We want to bring the right trials to the patients through their care teams, and thereby improve their own outcomes as well as align with the health system's population health interests.
Can you elaborate more on how research furthers the mission of value-based care?
Value-based care is all about measuring and delivering improved outcomes for patients and typically focuses on specific populations that generally are more complex to manage. It relies upon a more collaborative, team-based approach to delivering care.
Research can be a natural fit to this team-based approach. If you think about it, clinical research is a high-touch, highly structured means of engaging with patients. In every trial, you're closely monitoring the patient's primary symptoms, their safety, and their medication adherence. This structure by itself promotes patient compliance with medication and other health regimens. It promotes open communication and understanding of the patient's needs. Even if the patient is on a placebo, participation by itself lifts patient outcomes. And because this is funded through pharmaceutical sponsors, it's delivered in a cost-neutral, even cost-offsetting, manner for the healthcare organization.
When we engage health systems, we focus on their population needs, and bring a matching portfolio of research options to fit those objectives. For instance, we may focus on COPD and diabetes, because those are often large population health challenges where outcomes are highly responsive to lifestyle changes. By improving patient outcomes, we may reduce components such as costly emergency room visits.
That's a compelling value proposition. Besides your positioning, do you operate your research differently?
Yes, our research teams embed themselves into the care teams. The most critical player for Javara is the "Clinical Trial Navigator." A Navigator does the work of the primary coordinator on a trial, but that person is also a member of the care team that collectively cares for a given patient. For example, when our Navigator is screening a patient for potential trial eligibility, he or she may identify that the patient would benefit from participating in a care management program, or some other system initiative, and ensure appropriate communications occur within the care team. In this way, we serve as another touchpoint for the patient to reinforce the holistic, team-based approach to medicine that these systems are adopting.
How have health systems responded to this new approach?
It's been overwhelmingly positive. To date, most systems have viewed research as a necessary loss leader to engage physicians who want to pursue it as a personal endeavor. We shift that framework. We position research as a population health management strategy for the entire organization.
How has pharma responded? Are they open to this approach?
Yes. Many of them view our model and strategy as a very promising avenue to access patient populations and shrink the life-cycle of drug discovery.
What is the biggest challenge with your model?
On the health system side, it's mostly engaging with them when it fits their priorities. For instance, if the system is undertaking a major EMR transition, then they will likely put an initiative like this on hold.
On the pharma side, it's mostly convincing some of the companies and/or decision makers to look past the relative lack of research experience of the investigators. As an industry, we have to change this mindset. We have to understand that most of what drives successful trial operations are the underlying processes, systems and teamwork of the staff, not merely the individual contribution of the Principal Investigator. So when sponsors look at site-based research teams, they should consider the collective experience and capabilities of the team, not just the investigator.
That's historically been a challenge when working with research-naive physicians. Are you finding that this mindset is changing?
Absolutely. There's a contingency within pharma who understand this and are eager to work with us to be part of a new found solution. For others, it will take some time and they will migrate to this model as additional data is available to demonstrate value through case studies.
So your initial case studies will be critical.
Very much so. We are putting in place measurements to demonstrate the success of our initial trials. For the health system, that means we work with them to measure outcomes on their terms ? e.g., patient outcomes, engagement scores, cost of care, etc.
Once we have the initial proof points, we're confident we can get the support of leadership at major health systems and pharmaceutical sponsors, and bring them together. That will make these concerns about research naivete recede greatly.
You've chosen to go with your own research-specific technology platform, including electronic source, as opposed to using your partners' existing Electronic Health Records (EHR) systems. Can you elaborate on that decision?
I certainly understand why a lot of people would view the EHR as a promising technology to capture source data. But most EHR systems aren't designed to capture research data at this time. In clinical trials, data has to be extremely precise and the way in which we collect this data is equally as precise. In research, it matters whether the blood pressure was taken after 5 minutes in the sitting position or 10 minutes in the standing position, and you need structured templates to document these details. EHR systems, on the other hand, have a lot of unstructured data.
At some point, I foresee systems evolving so that eSource and EHR are integrated. But right now, the first step is to eliminate paper and adopt electronic source. It would be difficult to achieve our goals relying on a paper-based model.
What would happen if you succeed in your mission?
There is a tremendous opportunity to drastically change the landscape of research when you consider how many volunteers the clinical trial industry needs each year. There's a vanguard of organizations like us working to fulfill this need. It will take a lot of effort and different strategies to close the gap, and by doing so we can help bring more medicines to market for patients in need.
--Amanda Wright is Vice President of Partnership Development at Javara Inc., an integrated research organization (IRO) which partners with academic centers and health organizations to deliver research as an embedded option within a value-based care delivery system. Prior to joining Javara, Amanda was an executive at PMG Research, a major site network, where she began her career as a clinical research coordinator. Amanda serves on the board of Greater Gift, a non-profit that celebrates clinical research participation and connects participation to global health and well-being, and serves in a variety of industry advisory and leadership positions.