By Deborah Borfitz

February 5, 2025 | The growing convergence between clinical research and clinical care—and ways the second Trump administration will be encouraging and supporting movement in that direction—was the topic of the opening keynote presentation made at this week’s Summit for Clinical Ops Executives (SCOPE) in Orlando. It was presented as an informal but informative dialogue between Janice Chang, CEO of TransCelerate Biopharma, and Mark McClellan, director of the Duke-Margolis Institute for Health Policy.  

TransCelerate has been “galvanizing the ecosystem” around many of the activities enabling convergence for more than a decade now, but only recently made it the centerpiece of the nonprofit’s strategy, says Chang. Over the past year, she and McClelland have established project teams to work on their shared goals. 

McClelland was formerly commissioner for the U.S. Food and Drug Administration (FDA) and administrator for the Centers for Medicare & Medicaid Services (CMS). At the Duke-Margolis Center, he says, work is focused on opportunities to innovate and develop better evidence as well as facilitating improvements on the care delivery side. “We have some unprecedented opportunities for making progress,” he says. 

A tremendous amount of progress has already been made, adds McClelland, citing the digitization of the healthcare system, analytical tools and support, artificial intelligence (AI), and the development of medications that are more advanced than ever before. The election of “Trump 2.0,” like any new administration, will have major consequences for how things will next play out. 

Sweeping Changes

As with the first Trump administration, the policy emphasis will be on the economy, bringing prices down, and strengthening U.S. companies and jobs with tariffs and deregulation while looking for ways to cut government spending to pay for all that, McClellan says. Among the new features of Trump’s second term are big efforts to reform the way the healthcare sector works and reduce regulatory burdens and wasteful spending, most notably through the Department of Government Efficiency with “connections to every single agency.” 

Trump stirred up considerable commotion when he empowered the Office of Personnel Management to pursue massive federal workforce cuts. He also held to his pre-election pledge to pick Robert F. Kennedy Jr., an anti-vaccine activist, to be the next secretary of the Department of Health and Human Services (HHS) and lead the Make America Healthy Again Movement, McClelland continues. 

What happens next on that front remains to be seen. The last time Trump won, his only day-one executive order was intended to repeal the Affordable Care Act and “that didn’t work out,” he notes. 

This time around could be different since Trump is tapping into “the very real frustration that Americans have with the accessibility, cost, and complexity of their healthcare system,” says McClelland. And he is “moving in some very good directions” in terms of the emphasis on prevention and strengthening primary and longitudinal care. 

One of the concerning trends is that Kennedy, his HHS pick, will not stand by the safety of vaccines for children in the face of an abundance of available evidence, he says. But overall, the new administration brings “a lot more energy and directions that in many ways align with the priorities that agencies throughout the federal government started implementing in the last administration.” 

The FDA now has a program that spans across the Center for Drug Evaluation and Research (CDER) and supports innovative approaches to conducting clinical trials and the use of real-world evidence in product development. As CDER Acting Director Jaqueline Corrigan-Curay, M.D., has said, “it’s time for culture change in industry, too, [and] we’re here to meet you.” 

The National Institutes of Health (NIH) is “supporting more pragmatic, embedded clinical trial platforms, especially around primary care,” he adds. Both agencies will be getting new leadership, and the incoming nominees hold views that will “disrupt the traditional way things have been done.” 

The Biomedical Advanced Research and Development Authority, meanwhile, is now adding infrastructure to do more rapid studies with existing drugs and design drugs like monoclonal antibodies and mRNA treatments that can enable rapid responses to emerging infectious disease threats, says McClelland. “This is an area where RFK promised to keep funding and support in place.” 

Offices such as the Secretary for Technology Policy that oversees digital standards and the Advanced Research Projects Agency for Health have additionally put significant effort into supporting the use of digital tools in clinical trials and facilitating better evidence development in real-world practice, McClellan says. Celebrity TV personality Dr. (Mehmet) Oz, Trump’s pick to run CMS, also has a lot of experience with digital health and innovative approaches to care delivery and the capture of information from electronic health records. 

The view across federal agencies is that their intended activities will increase access to clinical research, which is precisely the goal of TransCelerate. “There are going to be some disruptions,” he points out. “But beneath all of this is a strong, some would say even stronger, push towards privately led efforts to transform the way that evidence is developed and the way that we support more accessible, high-quality clinical practice.” 

‘Stay the Course’

Chang implores clinical trial stakeholders to “stay the course” with activities TransCelerate already has underway to simplify study protocols and design studies better aligned to the realities of real-world patients so the outcomes are more relevant and impactful. “We still need to modernize all the antiquated processes and systems and, frankly, human interactions in how we conduct clinical research.” When it comes to advancing change, often “we are getting in our own way.” 

It's not that industry hasn’t been making some headway, she quickly adds. “We have to continue to focus on the data”—how it is collected as well as what gets collected, how it gets used and reused, and how it gets shared—“and how we ensure the data is interoperable” among clinical research systems and across the healthcare system. 

Convergence of clinical research and care will require activating other parts of the ecosystem, says Chang. This means continuing to raise awareness and trust in research among patients and caregivers and increase the education of physicians and their participation in conducting studies. Health policies and payment systems also need to incentivize participation. 

What convergence success could look like in 2035 boils down to improved outcomes, expanded access, and a lower cost of drug development, Chang says. “What we can continue to do is simplify our protocols ... focus on the data, and ... make sure that we improve the experience from the patient’s perspective.”   

Mutual Frustrations

There are ample opportunities for building convergence between clinical research and clinical care delivery systems, says McClelland, because people in both worlds are feeling overwhelmed by the difficulty, effort, and cost of getting their job done. One of the top priorities of Dr. Oz and team at CMS, the country’s big public payer, is to find “visible ways they can make healthcare more accessible, convenient, and less complicated, and a big way of making that happen is through building on the foundations for data interoperability, giving people control over their own data, and making the kinds of payment reforms ... [the new] administration would strongly support.” 

It's about “getting away from traditional fee for service and helping people be part of coordinated advanced primary care and have coordinated access to longitudinal specialty care where they need it,” he says. The enablers are a combination of data, team-based approaches to care, elimination of regulatory barriers, and progress on the technology and AI fronts. 

When looking for a label expansion on a drug, McClelland suggests, sponsors might think about the realities of users on the healthcare delivery end who are likely already feeling stretched and struggling to keep up with their tight appointments schedule and all their patient referrals. CMS and many healthcare organizations are supporting “rapid learning continuous quality improvement” initiatives that engage patients earlier and follow them up over time so the ones who most benefit from treatment get access. 

“Those programs benefit from the same kind of reliable, longitudinal data that tracks what patients care about as well as cost and resource use, so I think there are opportunities for convergence,” says McClelland. This can effectively be accomplished by leveraging the mutual frustrations of clinicians and trial sponsors.  

Patients-First Mentality 

It has been “quite the journey” to get to the point of talking seriously about convergence, says Chang. The work of TransCelerate started with common data standards and then moved sequentially to development of its Common Protocol Template, tech-enabled protocol template, and finally its digital data flow work that includes digital visualization tools thanks to collaboration with industry, the Clinical Data Interchange Standards Consortium, and the tech community. 

To truly realize the potential of AI, she adds, “we as an industry must even further commit to adoption of data standards and the common data model.” It would be “for the benefit of the patients; that’s the important part.”  

A focus on patient perspectives aligns well with the intentions of CMS and new support for real-world evidence from the FDA and NIH via digital means that requires standards and understanding what the data says, McClelland says. CMS has been a prominent user of Bulk FHIR, a method of transferring large volumes of healthcare data using the Fast Healthcare Interoperability Resources standard, and United States Core Data for Interoperability (USCDI), used to ensure consistent data exchange across systems. This is how the agency provides access to Medicare claims data to healthcare providers and organizations interested in analyzing trends and improving care delivery. 

What trial sponsors can do now is focus a bit more on health economic considerations in their trials, he says. “Let’s say you get the label indication; what is a health system going to do with that? How can you help them build the capacity [to improve clinical care]?” 

This brings up the Inflation Reduction Act (IRA), one of whose provisions allows Medicare to negotiate directly with drug manufacturers to lower prescription drug costs. It appears that the Trump administration is going forward with it but “in a more transparent and more effective, collaborative way,” says McCelland. 

One of the chief complaints of life science companies about the IRA is that it reduces the exclusivity on small molecule drugs and biologics to nine and 13 years, respectively. It can take seven or eight years for the price of a new drug to start coming down, McClelland says, and reducing that wait presents “a mutual opportunity to increase access.”