With more than three decades of experience in clinical research, Javara CEO Jennifer Byrne has a unique and broad perspective of the industry. At this week’s 6th annual virtual Clinical Research as a Care Option (CRAACO) Conference—an event she and several colleagues helped bring to reality—she is bringing that insight to professionals focused on strengthening the connection between care providers and clinical researchers, for the good of the industry and patients themselves.
“[CRAACO organizer] The Conference Forum has a number of different conferences; their premier conference is DPHARM; when I had an opportunity to speak at DPHARM, a healthcare partner of mine at a pharma company, and a patient survey company, and I had an opportunity to come together,” she said. “Before then, there really hadn't been any work that had been done or data that had been collected or evaluated in expanding the value proposition of research.”
Researchers frequently invite patients to participate in their studies to answer scientific questions, she said, and to gain regulatory approval for therapies. Byrne and her colleagues, however, knew research could mean much more to the patients participating and wanted to share it with the rest of the industry.
“We had had an opportunity to present some data, and it was the first time data had been presented in any type of forum where we were able to demonstrate thinking about how clinical research as an option for patients can take us to the most patient-centric orientation,” she commented.
In the presentation, Byrne and the others showed clinical research as a care option led to a number of benefits, such as reduced cost of care, elevated patient outcomes, and patients that came out of the study participation experience with increased satisfaction at their level of care.
Out of that successful presentation, the CRAACO Conference emerged.
“The idea was to create a forum to, in a really intentional way, bring together life sciences, pharma, CROs, all the channel partners, and healthcare,” she said. "We wanted to connect all these different industries and focuses, and level set the table for the patient.”
Now in its sixth year, the CRAACO Conference has grown from a close-knit advisory group of leaders to a comprehensive event that draws experts from large pharmaceutical companies, national hospital system executives, top academic institutions, industry associations, and more. Together, Byrne said, they are asking serious questions on how to integrate care and research.
Many of those serious questions were addressed during a “fireside chat” at CRAACO that Byrne moderated. The session brought together three emerging investigator physicians to share their experience and newly gained perspective: Ron Blair, MD, president of Forest Lane Pediatrics; Charlotte Grayson, MD, partner and internist with First Georgia Physician Group; and Tina Kennelly, MD, director of research at Tryon Medical Partners.
“These are three physicians that this time last year were not involved in research as qualified investigators, and they have all worked very hard to quickly jump in to complete training and integrate clinical trial operations into their practice,” Byrne told OSP. “These are physicians who really believe in the responsibility they have to bring forth clinical trial participation.”
Unlike the seasoned clinical trial professionals taking part in other sessions, the three panelists are looking at the challenges of uniting care and clinical research with new eyes.
“Their entry point into research is a desire to bring clinical research as a care option to their patients,” Byrne said. “They're not pivoting from a different orientation; it’s really their starting point.”
The ins and outs of the clinical trial industry that the three investigators of the fireside chat are just starting to learn, Byrne is more familiar with; with a career going back to the mid-1980s, she has witnessed a great deal of growth and change in technology, regulations, and the way research institutions are structured and sized, as well as how patients are impacted.
“The evolution of clinical trials actually continues to bring more and more complexity; that is a common thread,” she said. “Trials aren't getting easier for patients to connect into, and they’re also not getting easier for physicians, who want to be part of the clinical trial landscape.”
For example, Byrne said, back then the number of compounds in the drug development pipeline numbed in the very low thousands; now that figure is closer to 18,000. Also, only a handful of pharma and life-science companies occupied the landscape, whereas now there are thousands, with numerous large and small contract research organizations (CROs) serving to manage the trial execution.
“Everything is bigger and there's just more of it—that is a testament to the evolution of new drugs, new devices, and our ability (from an advancement standpoint) to become far more targeted,” she explained. “We have diseases and conditions today that we didn't even know about five years ago; that complexity is important, and it is necessary, but it does make operating in this landscape so much more complex.”
Pharmaceutical companies sponsoring research have more complex waters to navigate, too. For example, they have the option of partnering with a wide array of organizations like CROs, integrated research organizations (IROs), and site management organizations (SMO); each entity offers different capabilities and benefits that appeal for different reasons.
“I never want to come out and say, ‘This is the right one’—we need all of these,” Byrne said. “CROs are still built-for-purpose for life sciences. SMOs are built-for-purpose to respond to the needs of pharma and biopharma; SMOs also are built for providing services to CROs, because most of the work out there is outsourced to a CRO, so you have to be positioned and able to work with the middleman. SMOs historically were built to allow local physicians to participate in research, and to connect that to industry and CROs.”
“In the case of IROs, with Javara, we launched the company three years ago, but the whole concept around the integrated research organization you can liken to what the CROs were created for in the 1980s,” Byrne continued. “Could pharma companies do their own research? Yes. Were there limitations and scale issues with them completely insourcing that? Yes. Can health systems do research on their own? Absolutely. Do they do it on their own? Absolutely. Do they do it well? In some cases, from a quality standpoint, yes; in some cases, they have difficulty in scaling.”
Healthcare systems often do tackle research efforts within their own organizational framework, but they frequently struggle and lose money on the effort.
“Their primary mission is healthcare delivery, and clinical research is a very, very specific component that takes a different structure,” Byrne explained. “In the IRO model, we still work with pharma companies and with CROs, just like SMOs do, but we are really partnering--we're not standing up our own research center disconnected from the health system. Our teams are integrated into the sites to partner with the physicians and ensure they and the patients have the support they need throughout the trial journey.”
Byrne suggests that a key solution to contend with the complexity, disconnection and other challenges faced by everyone in the research pipeline could come through forging stronger connections between patient participants, their care providers, and clinical researchers. Building stronger relationships among these stakeholders is something she’s spent a great deal of time considering.
“I have spent my entire career enabling doctors and patients to participate in research at the ground level,” she pointed out. “My career has been very centered on boots on the ground, in the clinic, building business models, building partnerships, building teams, around helping doctors bring research to the forefront of their practice.”
In part two of this series, Byrne will address suggestions to strengthen the connection between clinical research and patient care, and the contributions key players can make to bring about needed change.