Louisiana’s largest non-profit, academic health system, Ochsner Health, announced a partnership with Pfizer to design, develop and validate for production, digital tools to help make clinical trials easier for patients, clinicians and researchers. TrialSite News is encouraged to see examples of major pharmaceutical companies forging alliances directly with major health systems to produce user friendly, purpose-built digital health tools. Ochsner is making this possible by utilizing their innovation division—known as innovationOchsner (iO). An innovation lab, it has been set up to solve healthcare’s most pressing challenges that Ochsner, like every other health system, faces daily. iO partnerships include Microsoft, GE Healthcare, Apple, Epic, Sotera Wireless, Doximity and others. Within Ochsner, key leadership has identified that health care professionals need to develop new approaches and methods to engage and motivate patients to proactively participate in their own healthcare—via monitoring, maintaining and enhancing their own health. The healthcare crisis in American absolutely requires this kind of response—multiplied many times over. In parallel forthcoming process and digital innovation must impact providers—simultaneously supporting the improvement of quality through advancements to how patient conditions are effectively and efficiently managed.
The core mission of the Pfizer & Ochsner alliance is to develop digital tools for clinical trials. Although a multiplicity of “eClinical” vendors exist—marketing everything from electronic data capture to patient reported outcomes, not to mention an explosion of various “apps” on the market targeting clinical trials—it is apparent that the vendors are, in many cases, falling short. The industry has been struggling to truly liberate innovation and productivity in the context of clinical trials. Now a good part of this is self-imposed by the commercial sponsors. Bureaucratic, risk-averse and often driven by middle management that don’t have the necessary skills, attributes and wisdom to drive tech-driven innovation—consequently, many big pharma “digital” programs are destined to fail. But the considerable vendor pool, many can argue, has fallen woefully short. Perhaps the same big pharma mind-set has affected the established clinical technology vendors?
Enter the health system: now big pharma, in this case Pfizer, seeks to go outside of even a clinical research organization (CRO) partner—directly to a health provider (Ochsner) to drive change. Inking a multi-year alliance, the alliance centers on a goal of improving “access and connectivity to clinical trials for patients, with the ultimate goal of better experiences and outcomes.” A ubiquitous underlying objective always includes the streamlining or processes, paper-reduction and the true nirvana—highly appealing, easy to use and intuitive interfaces for patients (think how easy it is to shop on Amazon, or to navigate the iPhone and the ease of use goal becomes clearer). Of interest, the entire effort will be driven by Ochsner’s innovation lab, innovation Ochsner and Ochsner Research. To Pfizer’s credit, they had identified their gaps for what they are, we suspect, and are not recreating the conditions that helped digital projects fail in the past (e.g. internally run digital innovation, outsourcing to CROs hoping they provide the innovation, or depending on the existing clinical tech vendor pool or big pharma consortium product development).
In seeking to make clinical trials interaction easier for patients, providers and researchers, Pfizer and Ochsner apparently have already been at work. A pilot was designed to support the transfer of mock data from Ochsner’s electronic health record (EHR) system (EPIC) to Pfizer’s electronic data capture system. Seamlessly tying these two systems together (via open APIs, web-services and standards ((FHIR), HL7)) in the context of a clinical trials, it introduces compelling benefits, including first and foremost actual interoperability between two mission critical systems that works. Additionally, advantages will include: lightning-fast bi-directional data transfer; higher quality; synchronized data management which ultimately supports compliance and patient safety; and overall superior digital collaboration during site activation through study conduct and close-out. This ensures greater adherence to ALCOA principles (attributable, legible, contemporaneous, original, accurate).
Both Pfizer and Ochsner appear significantly upbeat about their progress. Both are on a march down the GcP-validated digital clinical trial product development path. Celebrating the recent EHR to EDC pilot success, Rob Goodwin, VP of Pfizer Operations Center of Excellence and Global Product Development stated:
“We’re pleased that we succeeded in transferring core data types collected in healthcare provider electronic health records to Pfizer’s clinical trial data capture system using FHIR standards.” To the best of our knowledge, this is a first for our industry.”
Before proceeding a note on the importance of health data standards and interoperability, TrialSite News’ principals have been deeply involved with development and implementation of cloud-based, standards-ready, community care coordination for Medicaid waiver care coordination programs across the United States. We implemented a FHIR-enabled data interoperability solution for a Medicaid-focused accountable care organization in a western state. We can attest to the critical importance of commercial sponsors embracing FHIR for creative new ways to collaborate to benefit patients, providers and researchers. Providers have embraced FHIR for some time to meet Meaningful Use mandates among other objectives. Connecting EHRs, EDCs is not a new topic. Feasibility conditions improve with market demands, modern software APIs and web services—not to mention an openness to collaborate in new ways. There are many obstacles, starting with the need for executive vision and buy-in throughout all participating organizations; middle-management execution; quality assurance and IT/IS division alignment; identifying and mobilizing the necessary talent; and funding and implementation commitment—all of which are no small matter.
The Ochsner article highlights that this deal is part of an ongoing collaborative trend between sponsor and provider systems. For example, Pfizer recently announced a collaborative partnership with Jianke.com, China’s online healthcare platform. In that deal, Pfizer seeks not only greater penetration into China’s healthcare consumer market (via retail, hospital and internet), but also greater brand awareness for its health products via “co-creation of an omnichannel retail system,” combining online and offline channel elements.
Moreover, Ochsner reports that it was one of the first health systems to participate in the Apple Health Records launch in January 2018. Its innovation group has been sourcing, qualifying and negotiating multiple technology partnerships in pursuit of an apparent digital health product mandate.
TrialSite News will monitor and report on the Pfizer and Ochsner digital tool collaborative closely. We will also keep an eye and ear out for other interesting and noteworthy clinical trial technology partnerships. We find it interesting that there is an explosion of disruptive applications hitting the market for clinical trials—from telehealth platforms to big data machine-learning-driven insight decision support, to a multiplicity of GcP-ready apps for patient data capture, to several cloud-based modernizations for application classes, such as EDC or trial and site master file. This is not in question. Hundreds of millions of dollars, to billions of venture capital, private equity and public money via IPO is channeled into the clinical trial technology market alone. Yet, the existing vendor pool is not effectively driving commercial sponsors forward at the required velocity. Undoubtedly, commercial sponsors’ organizational structure, culture, risk aversion, etc. impact the existing clinical technology vendors, who have some culpability in slowing progress down in some cases. The Pfizer and Ochsner represents a very interesting data point in a growing trend. Will it materially impact the patients, providers and investigators at the two organizations?