By Deborah Borfitz 

February 27, 2024 | How to go about integrating research into the care continuum was the topic of the keynote opener at last week’s Summit for Clinical Ops Professionals (SCOPE) in Orlando. The multi-stakeholder panel advocated for a mix of courage, collaboration, and cross-industry learning to turn the vision of bringing trials to patients a reality over the next 15 years. 

Katherine Taylor, head of risk evaluation and adaptive integrative monitoring at Merck, served as moderator of the plenary keynote that doubled as a Super Bowl party for attendees in their Chiefs and 49ers jerseys. The talk was peppered with an African proverb (“If you want to go fast, go alone; if you want to go far, go together”) and quotes by civil rights activist Martin Luther King Jr. (“The time is always right to do what is right”) and Maya Angelou (“I've learned that people will forget what you said, people will forget what you did, but people will never forget how you made them feel.”) 

Achieving the vision of normalizing trial participation through the convergence of clinical research and clinical care will require a SpaceX type model that Elon Musk has adopted to get man to the moon, according to Uli Broedl, M.D., senior vice president and head of global clinical development and operations for Boehringer Ingelheim. As it stands, it takes upwards of eight years just to bring a drug to market and at least that long thereafter for it to become the standard of care where every patient benefits. 

One of the first orders of business is to bring down costs, as SpaceX did by building reusable rockets, he says. Research as a care option will likewise take precision navigation and communication. And, like the management of many orbiting satellites, it will require multiple payer groups and regulatory agencies coming together with a patient-first mindset. 

The long sequential process of clinical research as conducted today needs to be recast as a “continuous loop of real-world evidence generation emphasis and application,” says Broedl. The prerequisites include decentralization, innovative trial design, and creation of a learning healthcare system with end-to-end digital data flow, interoperability, and aligning incentives across stakeholder groups.  

It’s a vision shared by panelist Janice Chang, CEO of TransCelerate Biopharma, Inc., who won applause by championing the idea of managing health rather than managing disease. In the future, as she imagines it, clinical research will be among the first options considered—not one of the last resorts.  

Speed and quality are already clinical trial imperatives, but more of each will be necessary to make research a part of routine healthcare, says Christoph Koenen, head of clinical development and operations in pharma research and development at Bayer. In addition to moving from high-speed train to spacecraft-level momentum, the transition will involve an expanded definition of quality to consider not just data but health-promoting innovations benefitting patients and society. 

‘Decluttering’ Operations

Over the last decade, TransCelerate has been “decluttering” the way clinical research gets done to eliminate operational efficiencies that are largely self-imposed and have been driving sites and patients nuts, reports Chang. The collaborative has embraced the idea of merging clinical research and clinical care but knows it can’t go it alone. 

One of the big self-appointed missions is to “move away from patient-centricity being just a buzzword” and focus on developing implementable tools and processes that truly put patients first, she continues. “How do we co-design trials with patients, how do we have templates and tools and processes in place so that we are actually getting continuous feedback from patients, and how do we make sure that trial results are returned back to patients in a meaningful [interpretable] way?” 

TransCelerate expects to accelerate the journey to this desired end state by partnering with other industry groups and regulators, adds Chang. Every stakeholder group in the clinical trial ecosystem has a role to play.   

The main barrier to the convergence of clinical research and clinical care is the expectation that patients come to investigators, says Koenen. If effort and energy are instead spent creatively integrating the trial as much as possible into the continuum of care, patients will not even notice they’re participating in a trial because it is no longer a burden to do so. 

Importantly, doing so will enable trials to “reach a completely different group of patients because right now we have a patient population that is too male, too white, not old enough for a lot of the interventions that we are testing, and that’s not good enough,” Koenen says. Payers and regulators both recognize the need for research to reach the patients in which medicinal products will be used and accomplishing that will require decentralizing studies as much as possible using currently available tools.  

“We have to choose to do the right thing even when it’s the harder thing,” emphasizes Chang, pointing to the power of the sizable SCOPE community. “We have to think about how to truly leverage technology advancements and... activate and engage with different stakeholder groups, particularly patients in a way that’s truly meaningful to them.” 

Investigators, sites, and healthcare providers could be leveraged in ways that make them feel part of a common journey, Chang says. Sponsors might also think about streamlining the data-collection process by focusing only on the data they really need.   

Chang’s call to action is to “bring it back to the human interaction” and for clinical operations executives to forge meaningful connections with their industry peers. She encourages “being curious, learning from each other, [and] being compassionate” as well as having the courage to respectfully challenge the status quo. 

“The best way to predict the future is to create it; put the two together,” advises Broedl.  

“Don’t be afraid of being creative... [and] of stealing and learning from other industries,” Koenen says. “Take any innovation you think makes sense and integrate it into how we conduct research.”