Tips For Improving Patient Engagement and Clinical Trial Experiences

By Deborah Borfitz 

February 28, 2020 | As part of its ongoing efforts to build a patient-centric culture, Takeda is taking patient engagement in drug development to a whole new level, according to Jessica Scott, M.D., JD, head of R&D patient engagement. “Patients want to be part of the process and share the experience with us,” she said from the stage at the 11th Annual Summit for Clinical Ops Executives (SCOPE) last week in Orlando. 

Engaging patients in a two-way dialogue is much more illuminating of their needs and concerns than talking to their healthcare providers or reading the literature, Scott says. “Patients are struggling. They feel faceless, like a ‘subject.’ We want to be better partners… [and] move the needle.” 

Last year, the partnering initiative challenged the entire global program team at Takeda to engage in three patient-oriented activities, which could include attending live events and reading patient stories, says Scott. Identifying and tracking one or more patient engagement activity was among their annual goals.  

Thirty percent of global teams developed a patient engagement plan in 2019 and, in 2020, all teams are expected to do so, she says. Planned activities are designed to foster interpersonal communication. 

Scott says several overarching themes sum up what’s most important to patients: 

  • Clear expectations. “They don’t want to be surprised; they want to plan.” How long are site visits? How many visits are required? Will they have to pay out of pocket? What’s the rationale for the different tests? Will data be shared when the study ends? 

  • Plain-language summaries of clinical study findings, including individual-level results. As reported elsewhere, this rarely happens today—even in the aggregate. 

  • Reduced burden of trial participation. “We’re not doing a great job,” says Scott. Plan from the patient perspective, she suggests, looking at what can be bundled into a site visit and if excessive numbers of lab samples are being required as a backup plan or to accommodate too many endpoints. “Get the input of patients as you develop the protocol.” To offset some of the burden of participation, offer a concierge transportation service rather than require patients to tally and submit receipts for payments months later, she adds. Alternatively, do more home visits or work with nearby labs and imaging centers. Or hire a navigator so families—especially single-parent homes or those with more than one sick child—aren’t making all the decisions alone. 

Endpoints may need to change, says Scott. Patients with Friedreich’s ataxia, for example, may be more interested in their fine than their gross motor skills if they’re already in a wheelchair. 

Keep expectations realistic, she says. “Representativeness” in trials will take time to achieve. 

Most drugs will not make it through the development process but be honest with patients about the failures rather than avoiding the conversation altogether, Scott continues. “Results may be disappointing, but patients will be thankful that you shared them.”  

The idea, concludes Scott, is to rebuild trust through patient engagement, “to learn what we don’t even know we don’t know.” Takeda has seen “tremendous value” in each patient engagement exercise but is not formally tracked ROI, she adds. 

Patient Stories 

Three patients shared their stories and perspectives on the clinical trial experience during a follow-up panel session moderated by Amy Froment, head of global trial optimization for Regeneron and Andree Beckerling, CEO at Clariness. 

Lenny, a 44-year-old man who was diagnosed with hepatitis C in the 1990s, went through two rounds of chemotherapy and a pair of clinical trials before he found a cure for the highly stigmatizing disease. “I’m not an IV drug user and I’m not homeless,” he immediately shares. 

His gastroenterologist referred him to the first trial at Shands—a two-hour drive north from his home in Orlando—which involved daily injections of a powerful antibiotic for 10 months and didn’t work, he says. “I felt terrible, like I let people down.” 

But Lenny was undeterred. In 2017, he tried another study at Shands that added two potent antiviral agents to the original cocktail and by week six he knew it had worked, he says.   

Stephanie, a middle-aged woman with a multitude of ailments that include autoimmune autonomic ganglionopathy (AAG, a rare disorder), lupus and celiac disease, had been actively searching for a trial because the marketed drug that was “working wonders” wasn’t covered by her drug plan. After her AAG diagnosis last year, she became bedridden and was suffering frequent dizzy spells brought on by abnormally low blood pressure. She was forced to hire a full-time caretaker and housekeeper.  

She had no luck finding a suitable trial on, she says, but a friend alerted her to a trial opportunity in Orlando that even her regular doctor did not know about. The study drug offered relief, and Stephanie was able to continue taking it when the trial ended and start enjoying life again. 

“Use Facebook” was her recommendation. “I’d answer questions if they’d pop up on my newsfeed.”  

David, the third patient panelist, was diagnosed with psoriatic arthritis 14 years ago and hails from the UK. His first clinical trial ended in “disaster” after a couple weeks, but his second trial six years ago was “lifechanging,” he says. Skin rashes were impacting his daily life, he had run out of treatment options, and was contemplating suicide.  

That was when David spotted a poster on the hospital wall about a new trial opportunity. He was on the phone with the research center before he left the building. A lot of communication thereafter happened via email, including 28 pages of details about the study. “It was so boring… and I was not well,” he recalls. 

David says he was surprised he even make it through the screening process, given his multitude of symptoms that included a high body mass index. His friends and family were actively discouraging him from participating. “The UK media is very anti-clinical trial,” he notes. 

Weekly injections into his stomach, which he eventually (and reluctantly) self-administered, eliminated his skin scaling after 10 weeks. Shortly thereafter, a moisturizer completely erased his reddened skin, David says. 

“The process was pretty good” but communications were limited to the telephone and email, “quite old school,” he says. “How about an app?” 

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