By Deborah Borfitz 

March 18, 2021 | In the space of a year, the clinical trials enterprise has made “a decade of progress” in the way it conducts studies, according to Harlan Krumholz, cofounder of Hugo Health, who spoke about participant-partnered research at the recent Summit for Clinical Ops Executives (SCOPE). The pandemic has proven a more decentralized approach “is possible… and I would hold out the notion of trust as a key element.”

The current infrastructure is broken, as reflected in the expense and complexity of trials, and was created for a pre-digital era, Krumholz says. Today’s patients need not be tethered to sites, and working with them directly in new ways makes it possible to “delight them with the experience of research.”

Why trial participation has been less-than-pleasing up until now might seem obvious to patients, he adds. Product developers often must “capture” or “drag” back to studies and will “chastise” them if they do not comply with the protocol. 

“It’s a matter of our framing,” continues Krumholz. Partnerships need to supplant transactional relationships and check-the-box thinking. Cycle times and costs can be reduced by tapping near-real-time data streams and incorporating real-world evidence (RWE) into hybrid trial designs.

Creating “virtuous partnerships” with study participants means tipping the balance of power in their direction, he says. People want to see progress occur quickly, be listened to and respected, and have agency over their data. 

The pandemic has made innovation a matter of urgency, says Krumholz, and not just to create efficiencies but also to ensure an enduring change in mindset—including the adoption of policies and procedures that serve patients best. 

Hugo Health has already done one participant-centered study with the U.S. Food and Drug Administration and the agency is “eager” to see more of the same, Krumholz says. But the technology employed must be exemplary. Good software is needed to turn real-world data (RWD) into real-world evidence (RWE), and more work is needed to make it “regulatory grade.” 

RWD sources used by Hugo Health include electronic health records, pharmacy and payer data, and data from wearables. “Electronic sources introduce a lot of new problems,” he notes. Study participants should be delighted by their experience using the technology, which also must meet the needs of investigators and sponsors. 

“To delight patients takes time and iteration,” says Krumholz. Like an iPhone, the “exemplary nature of technology can’t stop,” he adds. “It needs to improve over time.” 

As with any cultural shift, change can feel threatening to many people, he says. “People hired to do one thing may need to do something else.” At the organizational level, the biggest threat is maintaining the status quo.  

If industry works with universities and federal agencies to talk about the need for the cultural shift, those executing trials will feel safe embracing new approaches, says Krumholz. “The risk is not greater at the end of the day, but the novelty [of the decentralized approach] makes people feel unsure.”

Among other lessons learned shared by Krumholz is that study sponsors “need to be worthy of the trust of participants. Align along areas of mutual interest, listen to their ideas and… tell them what you learn.”

Krumholz further advises building out communities where sponsors and participants can feel connected to each other. “If [a trial] is a failure, we need to tell them and if it is a success, we need to celebrate with them. And we need to move as fast as possible” since many patients are suffering and want answers.