Sponsors often are wary of involving patient insights in trial designs, despite evidence of success from the field and encouragement from regulators.

Sara Ray, senior director of research at online health social network Inspire, frequently encounters this concern. “One point of hesitancy,” she says, “is concern they’ll learn something that runs counter to what they want to do with the trial. And that risks throwing everything off.”

They’re right to worry, Ray says. “Every little change is going to be a risk.” The solution isn’t to ignore the patient voice, but to incorporate it earlier, before the protocol is finalized, she says. “Incorporating the patient voice early in the protocol design process gets it right from the start.”

Inspire supports more than 3,600 disease conditions reported by more than 1.6 million members, providing a wealth of patient insights.

Gathering such specific information — not from generic patients, but from precisely the type of patient the sponsor intends to enroll — informs protocol design. By listening to patients and caregivers, sponsors gain insights they’d find no other way.

So why aren’t more sponsors reaching out to patients? One reason is the misperception that it takes too long, Ray says. In response, she explains she can start a survey on Friday and have a finished report in a sponsor’s hands by the following Friday.

“They look at me like I’ve grown three heads,” Ray says. “I’m not saying I’m going to get a 100-page report in a week. But we can ask targeted questions.”

Those reports provide a simple way to get started. “A step up from a short, targeted report would be putting the entire protocol in front of patients — exactly like the ones you’re trying to enroll — and see what they think,” says Ray. Her favorite approach is to combine a survey with the qualitative insights so sponsors can see what patients are saying and understand why they’re saying it.

Another approach to gathering the patient voice is social listening. This can be done early in protocol design and takes about a month. “Gathering organic language from online communities, such as Inspire, can help those who are designing the protocol discover what patients and caregivers are naturally saying and concerned about,” Ray says.

Inspire has an algorithm that identifies key words and phrases that can answer important questions.

For example:

• What are patients and caregivers saying about other clinical trials?
• What are patients and caregivers saying about their current treatments? What makes their current treatments particularly burdensome?
• What are patients and caregivers saying about their measures of efficacy or success for treatment?
• What do patients and caregivers value in the treatments? Is it length of life? Quality of life? Something else?

Beyond that, Ray notes, sponsors need to understand, “What is [patients’] lexicon? This is something really important that is overlooked.”

• How do patients and caregivers describe treatments?
• How do patients and caregivers describe experiences?
• What words do patients and caregivers use and prefer? What terms do they dislike or shy away from?

“By learning their lexicon, you can find out what words resonate with patients and caregivers. In this way, sponsors show solidarity with the community that they are going to be involved with for months or possibly years.”

Having access to a patient community dramatically improves recruitment and enrollment. Knowing what those patients want is the key to site feasibility and retention.

But sponsors first need to understand who their patients are, says Jill Johnston, WCG president of study planning and site optimization. Johnston’s goal is to develop an investigational site profile for each sponsor.

“Along with inclusion/exclusion questions from the protocol, I need to get a sense of what kind of patient will be enrolled,” she says. Does the patient have a mild or severe version of the disease? What type of physicians would typically see that particular patient? A family physician? A specialist? What sort of specialist? Do they see other providers in addition to a primary one?

Without this information, “I might find out I was fishing in the totally wrong pond, if you will, because I made the wrong assumption about where the patient receives care.” And that’s an assumption that can devastate enrollment.

“Having that insight and combining that data to help me develop a “golden site profile” can make a world of difference between whether I have picked the right type of site or the wrong type for a clinical trial.”

Sponsors and CROs typically can’t do something like this on their own. Or at least, not in short order. For one thing, we often see they lack a way to access patient insights quickly, Johnston explains. “If you had to do this on your own as a pharma company, you might be able to just reach out to a couple patients you know, but that’s just two individual voices.”

That’s why having access to a community of patients who have that particular condition is so important, Johnston adds. “You aren’t dealing with one or two voices. You might be dealing with 10 or 20 or 30.”

There’s no shortage of experts who’ll try to tell you what patients want, Ray says. “Research panels may advertise that they provide ‘health literacy’ services, but as a linguist I have seen some recommendations from these panels that are not grounded in research.” In one example, a panel told her she needed to change “oncologist” to “cancer doctor” because “oncologist” was too difficult a word for stage 4 cancer patients. “A patient with stage 4 cancer knows what an oncologist is. That is not a weird word to them.”

Incorporating actual patient insights makes patients part of the research, not merely subjects. And patients very much want to be part of the research, Ray says.