Difficult patient recruitment in the U.S. is hardly a new topic. But the 2008 Drug Information Association meeting had a few strong sessions on the topic, as we discovered when Kendle International’s senior director of strategic patient access, Janet Jones, took the podium.
In a brisk, engaging presentation of perhaps 25 minutes, Jones covered ... well, the globe. She reviewed the relative merits of every major nation or region around the globe and discussed some of her firm’s latest insights into the challenges in each one.
Although sheer quantities of patients in China make it an attractive market, Jones said the ongoing delays in starting trials there are a mitigating factor. “It might take China a year to start up, and that might cut back on your willingness to go there,” Jones said. The Chinese are discussing ways to expedite the process, she noted.
Eastern and central Europe, naturally, remain go-to areas for trials, with well-trained investigators and large numbers of treatment-naïve patients. “The challenge in East Europe is distrust of advertising,” says Jones. “They describe advertising as ‘glossy.’ You need to be careful with the message that you present.”
She didn’t go into details, but Jones suggested that the central and eastern European regions may have taken on as much work as they can handle for the moment. “There is a capacity issue,” she said.
In Latin America, Jones said there is a notably different demographic mix than in North America, with a large population of pediatric patients. That’s a sharp contrast to the U.S., she said, where geriatric patients are in great supply.
In India, Jones said, differences in communication styles can make it delicate to discuss a shortfall in recruitment with an investigator. And word of mouth is probably more important than elsewhere, which can translate into much faster recruitment for trials that are well-perceived by local leaders or respected individuals in a village.
“It is important that everyone who attends the site is treated well, even if they don’t participate,” Jones said of India. Even people who elect not to participate in a trial may speak highly of it to others, persuading them to sign up. “It’s a relationship-oriented culture. If they are not treated well, you are going to have a big impact on a lot of people.”
We were surprised by Jones’s willingness to consider Africa. She does understand the political and economic instability of some parts of the region, which make selecting countries tricky. “There is a very strong doctor-patient relationship,” she said. The logistics of African trials may include finding patients in nontraditional settings—and some effort to find them again if they return to a remote village.
For all the talk of international trials, Jones said, knowledge of how the people in a particular country perceive themselves can be crucial. Said Jones: “We have to understand what it means to the patient. You can’t just put a local recruitment campaign into a global environment.” One size does not fit all.
There was also a fascinating presentation by Kate Spencer of a British advertising and marketing firm called Langland. Spencer didn’t articulate it as such. But she basically flipped Jones’s argument on its side, and suggested that understanding universal human emotions is another valuable way to find and retain patients.
“I’ve got no metrics, no numbers,” Spencer began, disarming the audience. But she did have pictures aplenty, and some of them moved.
Her thesis is that understanding the emotional environment of a particular patient group is essential to designing a recruitment campaign that resonates. We were about to dismiss that as psychobabble until she flashed a series of images or TV spots that were developed after one-on-one interviews with real patients.
In an osteoporosis trial, her team discovered that what drove women to participate was not concern about fractures or pain, but anxiety about one’s role as the center of a family or its guiding matriarchal presence. The ad campaign that resulted showed mothers and daughters together.
Another case history: low testosterone. We’re unaware of how prevalent the condition is, to be honest. But Spencer’s interviewing process illuminated male worries less centered on the bedroom, and more about a larger sense of physical vitality.
“It was actually much more holistic and not being able to participate in the activities that one used to enjoy,” Spencer said. “It was a lifestyle approach.”
In discussing the sorts of conversations that yield the insights for such campaigns, Spencer said they were clearly lengthy, intimate and probing in ways that might not happen in every corporate setting.
We can’t exactly pinpoint why, but we were most impressed by a campaign featuring women dealing with obesity. Spencer didn’t express a specific insight about that campaign, but she clearly thinks that drawing people to participate in science can be driven by more than just facts and numbers. “There is a different set of criteria that we need to consider that is not written down in the protocol,” she said. “That is the emotional criteria.”
All of the rational, logical ammunition that a sponsor may marshal to support study participation is all well and good, but Spencer feels that decisions to do anything are driven, in the end, by emotion. “It’s down to us to uncover them,” she said.
Patrick Clay, director of the Dybedal Clinical Research Center at the Kansas City University of Medicine and Biosciences, rounded out the DIA session. Dybedal’s investigators are faculty on the campus.
Many of the Dybedal patients are African-American or Hispanic, and Clay was interested in learning why people choose to participate in (or avoid) clinical trials. He did a survey. There was a bit of ambivalence about participating in science or being a “guinea pig.”
But one big obstacle is more mundane: lack of transportation. When the budget allows it, reimbursing patients for transportation is a big help. Clay advised sites to negotiate a pass-through budget item with sponsors to offer patients money for mileage to and from the clinical site.
The recent surge in gasoline prices has only worsened the situation for low-income patients. “We have individuals who are driving 200 miles one way to come into our studies,” Clay noted. “It is an amazing thing to say we will be able pay for your gas.”
Taxis are expensive, of course. But Clay was resolute in asserting that because the arrival of an incoming patient is confirmed with some precision (the taxi dispatcher calls the clinic) the site staff can be far more productive when cabs are used.
Bus vs. Barbecue
“We know that an individual is en route,” says Clay. “It has given us greater efficiency in our center. We feel we are getting more productivity out of our staff now that we know that the person is coming.”
Even in the U.S., of course, there are cultural nuances to consider. The rationale and nature of studies using a placebo, Clay believes, needs to be mentioned in study advertisements.
Clay (who is white) routinely engages with the African-American churches in the area, attending church functions and private dinners in a low-key effort to build trust in the community. But he still feels that for HIV and hepatitis studies, bus ads in Kansas City achieve greater results than notices on a church bulletin board. “We have to have a stronger alliance with [religious leaders] before our message is not just posted but talked about through someone they trust,” he noted.