You can look at patient recruitment as an operational problem. Or as a mathematical challenge. Rob Laurens, director of creative services at BBK Worldwide, would certainly understand those perspectives. But there is also the marketing savvy that helps patients understand whether a trial is right for them.
Laurens spoke about rescue trials at this month’s Clinical Trials Congress, held in Philadelphia. He stressed the importance of looking ahead. “Incomplete planning is usually the cause of these recruitment delays,” Laurens says. Given how basic and well-understood preparation is, and how frequently patient recruitment goes awry, it’s interesting that planning still needs to be mentioned at all.
Constructing The Message
In the case of BBK Worldwide, its technique involves equal measures of anthropology and poetry. To find patients, BBK has learned, one must understand them. Deeply. And once the targeted population is understood, simple phrases must be honed to appeal to those patients. Preconceptions about the theoretical appeal of a particular medication may not be in alignment with the beliefs of patients in the real world. Even for the same drug, the recruitment challenge in Guatemala may be different than India.
Laurens had some stark words for an industry that is generally more comfortable with euphemisms and indirect, oblique statements. “Very few patients participate out of altruism,” he noted. “Generally, for the more run-of-the-mill studies that run into problems, you really want to figure out what the motive is for participating.”
His firm recommends, if possible, site-by-site and country-by-country assessments of the recruitment details. That research is not undertaken as a dissertation in its own right. Rather, the goal is to be able to understand a subset of eligible patients well enough to be confident that a recruitment message will be well-received. “Messages are so important to get exactly right,” he noted.
At the Clinical Trials Congress, Laurens recounted a project that BBK had undertaken in multiple sclerosis (MS). The trial had run into trouble finding patients. BBK started talking to focus groups. Said Laurens: “I like to go to focus groups and listen to patients talk about their relationship to their condition from a standpoint of the words they actually use and how they actually talk about it. It’s interesting to see how statements are echoed or contradicted.”
The focus group work suggested that one issue for MS patients is the number of drugs they take daily—and the complications that accompany some of those medications. When the sponsor changed the recruitment message on the trial to refer to intolerable side effects from other medications, recruitment angled nicely upward. “With that messaging in hand, it turned around the conversation between the physician and the patient,” Laurens said.
Of course, he immediately noted focus groups are not essential in every case. Online surveys can inexpensively test several viable concepts at once. In other situations, such as pediatric trials with adult caregivers, one-on-one interviews may work best. That’s what BBK did in a trial for Pompe disease. Talk about a hard trial to fill: the condition affects a mere 25 infants annually. But messaging around ruling out the disease was effective in helping persuade parents to enroll.
Generally, it seems, patients facing serious illness can be less intimidated about participating in research than physicians or sponsors may expect. A breast cancer trial provides an example. The project had one apparently daunting element: women would have to sign up virtually on the same day as receiving their diagnoses. Some oncologists, Laurens said, were reluctant to use the same encounter to both deliver the bad news about a patient’s diagnosis and make the argument for her participation in a clinical trial.
BBK discovered that some women wanted to be aggressive and informed about their options. The imagery for the campaign turned out to be vaguely pugilistic, with a boxing metaphor of “come out fighting.” The focus groups had discovered that some patients really wanted comprehensive knowledge of their treatment options. And the result? “We enrolled about two months ahead of schedule,” said Laurens.
Editor’s note: Two of Laurens’ colleagues, Jaime Cohen and Linda Wolf, wrote this article for ClinPage last year.d9A2t49mkex