Jennifer Byrne (CEO of Javara) has a clear view of many of the barriers blocking the progress to clinical research as a care option (CRAACO), thanks to her three decades of industry experience. She also has a number of solid suggestions on how to remove the obstacles.
For example, Byrne told Outsourcing-Pharma (OSP), there is a frequent misconception among caregivers that patients aren’t motivated to be study participants in the first place.
“Research America surveyed thousands of people, and a question posed, ‘Do you want to hear about clinical research?’ The vast majority of people said, ‘Yes,” and their preferred way to hear is from their doctor," Byrne explained. “Yet, the widespread perception from many members of the medical community is that patients would never be interested in trial participation—that simply is not the case.”
In addition, Byrne suggested, in order to build better trust for research within the community, we need to build those bridges through proactive education and awareness about the research process and not only at the time when we need a particular person or population to participate. Community education and engagement will boost awareness of research and framing research as a viable care option for the individual may better increase interest in and trust for study participation—and that conversation, she suggested, could be stirred by known and respected clinicians and other influencers (clergy, community leaders, family members).
“There's an opportunity for people to be asking their healthcare professionals, ‘Do you have a clinical trial that might be a fit for me?’" she said. "That starts to plant seeds for more physicians and clinicians to consider getting involved in research."
“If we believe that clinical research should be a care option for all, then in my view we have to be very intentional because there are different strategies in how to address that,” she continued. "To better reach more patients, we must commit, as an entire system, to reaching underrepresented minorities to participate in trials. A key step will require strategies to include more underrepresented minority physicians as investigators and also building a workforce that is more representative of the population as well.”
Javara, Byrne related, is strategic on how it approaches staffing in different regions and develops its workforce appropriately, to better reflect the communities where research takes place.
“We are committed to building our local workforce to be representative of that particular community; it’s not just a one size fits all approach,” she said. “Javara cultivates talent at all levels and we have found that internships are another excellent gateway to entry-level positions and driving more young professionals toward research—it does not happen just because you want it to happen.”
Another challenge lies in the way the healthcare industry itself is evolving. In previous years private-practice physicians had more freedom to participate in clinical research and care, Byrne explained. Now, it is becoming more challenging because practices, hospitals, and healthcare organizations are consolidating and becoming more complex. Physicians, perhaps not long ago, were independent agents with more freedom to participate in trials are now more constrained in time and autonomy.
“The majority of US physicians and clinicians are employees of systems,” she said. “The complexity of consolidation in healthcare has added to some further challenges to being able to match the right trial to the right physician and their patient at just the right time."
Physicians who might be interested in bringing clinical care options to their patients are not always fully empowered or supported by the health system to do so. Because the ‘systemization’ of healthcare, in the US and elsewhere, causes a disconnect. Further complicating the matter, she told OSP, are M&A activities, the increasing link between the healthcare sector, financial pressure with healthcare costs as a growing part of the nation’s GDP, and other forces driving the market are all factors and deterrents to trial access.
However, she suggested that instead of continuing to struggle against the systems, healthcare and research could benefit in a symbiotic way for research to support healthcare and healthcare to support research.
“What if from a regulation standpoint, the responsibility for the conduct of the trial rested with the system—whether it's a hospital, a healthcare organization, the entity that employs the physician, or the entity that owns the electronic health records?" she said. "Rather than the ultimate responsibility for trial conduct to be at the hands of an individual physician, the overarching system would be more incentivized to support physicians participating in research? Today, it's the system that ultimately is the power broker to patient access, but it’s the physician that ultimately has more of the trust of the patient.”
Requiring oversight of research by healthcare organizations, Byrne suggests, also could add more accountability. The physician and clinical staff would be charged with making the clinical decisions and ensuring patient safety to the extent possible, she said, but the healthcare organization in question would ultimately be responsible for delivering on the promises of quality, meeting enrollment targets and regulatory and contract compliance.
“If the healthcare organization is on the line, then the system will ensure a much broader reach across that entire enterprise and ultimately will be better enabled to reach more patients across the system,” she said. “It would completely change the motivation and the construct and the prioritization of research if it was an institutional responsibility.”
The increasingly predominant view of healthcare as an economic force could work to the advantage of the clinical research industry by positioning clinical research (including the patient participant pool) as an invaluable part of the equation, Byrne suggests.
“The business of healthcare is very much driven by volume, and volume relates to market share (i.e patient access),” she said. “There are actually tremendous opportunities if we can expand the value proposition of clinical research and how research might be considered a tool to provide options for unmet patient needs; no alternative treatment/therapeutic available, out of reach due to costs, insufficient options due to therapeutic effectiveness or tolerance, are all a few examples of “unmet needs.”
“If you have a robust offering of clinical trials, then you have the ability to bring something to a patient base that they otherwise could not get from a competitor’s system,” she said. “You have a point of differentiation. From a system standpoint, this represents some really great opportunities.”
As a potential example for the rest of the healthcare industry to follow, Byrne pointed to Texas-based MD Anderson and their network of cancer centers, which include a comprehensive research program.
“Decades ago, MD Anderson saw an opportunity, and today, there are people who travel there from across the world, because the perception and the experience is that people have access to cutting-edge resources,” Byrne explained. “The ‘cutting edge’ isn’t necessarily solely from MD Anderson's innovations. Rather, MDA and other research centers of excellence have intentionally built a robust clinical research offering that patients might not otherwise be able to access within their own community."
Another suggestion Byrne offered is highlighting, rather than downplaying, the involvement of pharma companies in clinical research and care, as a way to help build patient trust.
"Today, patient participants of the COVID vaccine trials are wearing a badge of honor, and they know that they are specifically a trial participant for Pfizer, Moderna, AstraZeneca, Janssen, etc., and that's getting celebrated,” she said. “We're all cheering them on.”
However, that link between research and sponsor, Byrne pointed out, is not typical. What normally happens is that most trial participants (outside of COVID19 trials) do not identify the study for which they are participating as a specific biopharma company, but rather Dr. Smith’s study or a study at Northwell Health, as examples.
“From a community and a trust standpoint, the brand of the pharma company is relatively hidden; trials are very de-identified,” she said. “I really believe that that is a part of distrust; the pharma company is noted in the informed consent and possibly branding on the investigational product, but otherwise is de-emphasized. Typically, it is not highlighted that Dr. Smith, along with ABC Pharma Company, are together offering a trial."
On another front, government agencies like the US Food and Drug Administration (FDA) could contribute to a stronger connection between clinical research and clinical care, Byrne suggests. However, while she commends the FDA for their commitment to fostering improvement, she suggests regulators, much like researchers and healthcare professionals, are facing complexity and complications.
“It's not as if we have had FDA leaders who have been asleep at the wheel and have not recognized this; it’s very complex because the FDA sits within the Department of Health and Human Services and there’s a lot to navigate for that change to happen,” she said. “What I wish is the that public at large, regulators and administrators would actually see clinical research more directly connected to public health."
Overall, Byrne remarked, she believes the FDA is headed in the right direction, in terms of encouraging change in the clinical trial field.
"Current FDA leadership is actively advocating for better connectivity to clinical trials for all patients, especially those who have previously been hard to reach, as in underrepresented minorities,“ she said. “That’s really important, with the work, interest, and accountability that FDA brings forth.”
One idea Byrne suggests is for the agency to advocate broadening the pool of physician providers and clinicians, and to encourage creation of resources that make increased physician participation possible. Closer collaboration with medical schools to educate and encourage clinical trial involvement and advocacy for their students and residents is another example of how regulators can help shape the future.
Byrne said that despite all the challenges, she remains hopeful.
“Often, when I’m interviewing a new person just coming out of college for a clinical research position, and I ask my favorite interview question, “why do you want this job’, the most common response is that people want a career with meaning and to do good; to help make the world a better, healthier place,’” she said. “I think that's a really cool unifier. It's a wonderful universe of people….this clinical research tribe.”
In the next part of this series, acting FDA commissioner Janet Woodcock shares her views on clinical research and clinical care, and the agency’s role in supporting industry professionals.