By Allison Proffitt

May 3, 2022 | Ken Getz and host Deborah Borfitz explore patient engagement for the newest episode of the Scope of Things podcast. Getz, Executive Director & Research Professor at the Tufts Center for the Study of Drug Development (CSDD), shares what his research has revealed about how patient engagement efforts are progressing, where we’re stuck in a rut, and a crucial misalignment in the industry’s view of patient engagement and what clinical research participants actually want.

Patient engagement has become a bit of a catchall term, Getz argues, which means different things to different people. He views the patient engagement movement as an effort to nurture a productive and meaningful partnership between the clinical trial industry and the public and patient communities. The objective, he says, is to amplify public and patient voices to better identify and address collective needs and engage patients as partners in developing and delivering therapies. That’s a broad umbrella, he acknowledges, one that will require trust and respectful exchange.

While Getz has seen patient engagement become an aspirational, guiding principle, he also warns that the clinical trials industry has fallen into a rut. When costs run high, he says patient engagement corners are likely to be cut, and box-checking or tokenism starts. “We have a single patient who might speak with a clinical team or give a keynote at a meeting, and we can check the box and say, ‘We now have patient input into our programs!’” he says.

He applauds regulations and guidances from the FDA and EMA about real-world evidence, decentralized trials, demographic data disclosure, and the EMA’s return requirement of plain language trial summaries, but it’s just not enough, he says. We need even stronger requirements to integrate these initiatives.

Data—even good data—is not meaningful without continuous feedback, he points out. For example, having demographic data on a trial is not useful unless you also have disease prevalence data to assess whether the trial participants reflect the disease population.

Getz doesn’t write off the good intentions of sponsors and sites, but he observes that many good tools and technologies still don’t actually meet patient need. For example, there has been so much experimentation on convenience—conducting trials at more convenient locations, home delivery of medications, telehealth, wearables, logging patient reported outcomes from home, and use of mobile devices—yet, Getz points out, “Convenience is subjective.”

These investments sometimes yield meaningful returns, but they should be viewed as options to offer patients whose preferences will be wildly variable as determined by race, gender, age, burden of disease, and other social determinates. The opportunity and challenge, he says, is to do a better job using these tools and tactics to accommodate and manage the relevant preferences of a diverse participant pool while reinforcing a meaningful experience.

Crucially, convenience is a lesser driver of patient engagement and satisfaction than connection and control, Getz says. “We’ve seen, time and time again in all of our research on the patient experience that the importance of the relationship between the patient and the investigative site staff, their relationship with their healthcare provider during and throughout their clinical trial participation is integral to their feeling engaged and a partner in the process,” he says.  

Part of our goal, he challenged, should be public education. We’re all patients at one time or another, he points out.

The Scope of Things Podcast

The Scope of Things podcast explores clinical research and its possibilities, promise, and pitfalls. Clinical Research News Senior Writer Deborah Borfitz welcomes guests who are visionaries closest to the topics, but who can still see past their piece of the puzzle. Focusing on game-changing trends and out-of-the-box operational approaches in the clinical research field, the Scope of Things podcast is your no-nonsense, insider’s look at clinical research today.

Listen to Borfitz’s full conversation with Getz to hear more on patient advisory boards, the healthcare provider’s role in successful clinical research, and the public’s mistaken conflation of clinical care with clinical research.

Or catch up on our earlier episodes and subscribe for new content.

Episode 1: Craig Lipset Gets Real on our Decentralized Trials Future

The pandemic has certainly been a turning point for decentralized trials, and Craig Lipset, co-chair of the Decentralized Trials and Research Alliance (DTRA) says the reasons are clear: the industry’s risk balance has changed, he tells Deborah Borfitz, Clinical Research News senior writer and host of the new Scope of Things podcast. Now decentralized approaches to trials have become counter measures to the risky pandemic when patients couldn’t travel to sites. “Decentralized” is an umbrella term, Lipset explains, which encompasses both processes and technology—not just a lot of tech. A decentralized approach will impact how and where people participate, prioritizing flexibility, diversity, and expanding accessible geographies.