SCOPE 2025: Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There

Image Credit: Don Tracy

This year’s SCOPE conference in Orlando kicked off with a keynote address from Janice Chang, CEO, TransCelerate Biopharma, and Mark McClellan, MD, PhD, director, Duke-Margolis Institute for Health Policy, Former Commissioner, FDA. Titled “Fast Forward to 2035: What Success Could Look Like in Converging Clinical Research and Care—And How to Get There”, the duo discussed how the progress of clinical convergence has been driven by digital advancements, artificial intelligence (AI), and evolving regulatory frameworks.

McClellan noted that other than improvements in technology, a number of fundamental trends are also on the side of converging clinical care and research.

“This includes the digitization of our healthcare system, better analytic tools, and support for AI,” said McClellan. “Medications are also more advanced than ever. They’re able to help intercept and stop, reverse, or even cure diseases. But that means we need a healthcare system where we learn more about how not just to show how these products work in clinical trials, but also how to integrate them into clinical care.”

McClellan also brought up the recent presidential election, and how this will look under the second Trump administration, including efforts to erase regulatory burdens.

“There’s certainly some policies that will be carried over, but there’s some new features too,” he explained. “President Trump has brought in a number of people to try and take on these more systematic steps to accomplish some of these bigger goals around reforming the way the public sector works, reducing regulatory burdens, and reducing spending. This approach intends to tap into the very real frustration that Americans have with the accessibility, cost, and complexity of the healthcare system, with some ideas for solutions that move in a different direction, and more in the direction of deregulation.”

Chang noted that at TransCelerate, her team is focused on staying the course with its ongoing initiatives to simplify and improve clinical trial protocols, aiming to enhance patient experience, accessibility, and meaningful participation.

“We have already started some of those activities,” said Chang. “We need to continue to simplify our protocol design to be much more aligned to real-world experience for patients and make sure that the participation of those protocols is meaningful and actually accessible and from a patient's perspective. Ultimately, this is so the outcomes are much more powerful and impactful. We still need to modernize all the integrated processes and systems and frankly, human interactions in how we conduct clinical research.”

Chang also stressed the importance of continuing to focus on data, including the collection process, what data is included, how it’s used, reused, shared, and making sure the data are interoperable, not just amongst the clinical research systems, but also across the healthcare systems.

“There’s so much we can continue to do, and we have been doing it, but we need to continue to stay the course,” said Chang. “I do believe that everybody in this room has been making progress on that. But to continue achieving that vision and that aspiration of convergence of clinical research and clinical care, we need to continue to activate other parts of the ecosystem.”

Chang explained that there also needs to be progress on continuing to raise broader awareness and trust amongst caregivers and patients around clinical research. Additionally, she noted that education and participation in clinical research amongst physicians also needs improvement.

Closing out the discussion, McClellan summarized the session, highlighting the numerous challenges involved with conducting clinical trials.

“It takes a lot of time and effort to conduct a clinical trial, and it’s very costly,” said McClellan. “The people who are delivering health care today feel exactly the same way. CMS’s biggest priority is to make healthcare more accessible, convenient and less complicated. A big way of making that happen is through building on the foundations of data interoperability, giving people control over their own data, and implementing payment reforms. We’re talking about incentives that I think this administration is going to strongly support. It’s kind of a continuation of getting away from traditional fee for service, and helping people be part of a coordinated advanced primary care and coordinated access to longitudinal specialty care where they need it.”