Grassroots advocacy uses family relationships,trust to bolster patient recruitment
Patient recruitment often creates an insurmountable bottleneck for trials. But could that be because many sponsors and CROs are overlooking more grassroots-style ways of carrying it out?
That’s the assertion of LaVonne Goodman, a “mostly retired” internist and patient advocate who recently decided to help a Seattle clinic recruit patients with Huntington’s Disease (HD) and was wildly successful at it. The secret, she said, is having a personal relationship with many, many patients in one particular disease area.
Goodman’s husband died of HD 25 years ago, at age 36. Since then, eager to help future patients, she has kept a close watch on the field to see if any promising drugs have entered the pipeline. But all studies were observational in nature, designed to see how patients with HD were progressing, not to alter the course of their disease or treat its symptoms.
In the meantime, she saw patients with HD and led support groups for them, building relationships with many in the Seattle area and making a name for herself as a friend to families dealing with HD. She also worked on a survey that asked HD patients in the Northwest whether they would participate in clinical trials should any ever come along. The answer was a resounding yes. But nothing experimental entered the pipeline.
That is, until 2010. Earlier this year, Goodman heard that the first compound designed for motor improvement in HD patients was entering phase II trials. When she realized no one in the Seattle area was involved, she pressed the Huntington’s Study Group, an international collection of doctors. They sent her the name of a Colorado physician who primarily worked with Parkinson’s patients but had experience with HD. The physician had just moved to Seattle and joined the Evergreen Neuroscience Institute. Goodman approached her and the two decided to work together on the trial, with Goodman handling recruiting.
“I was known and trusted, and I’m a family member, so I can explain trials in a personal way,” she said. “They were waiting at the door, literally.”
Goodman almost immediately had 17 patients, 14 of whom made it into the trial. “And we still had people who wanted to get in” but didn’t meet eligibility criteria, she said. Evergreen emerged as the third best recruiter for the trial, among very established centers.
Why don’t we hear more stories like this? Goodman said the drug industry and the medical establishment tend not to take patient advocates seriously.
“Family advocates in general are not empowered to do this sort of thing,” she said, adding she was given a chance only because she had medical credentials, and the physician was new to town and had no patient base.
Under normal conditions, though, patient advocates such as Goodman aren’t tapped for recruiting. This, she said, is a wasted resource. Drug companies often will go to academic medical centers looking for patients, she said, and doctors there will try to train staff to recruit. This is backwards, she said.
“This is training from the top down, and you don’t necessarily get your most passionate people that way,” Goodman said. “Instead, why not find out who’s passionate about a disease area, then train them on how to recruit? After all, I don’t think I’m unique.”
The personal angle is key, Goodman added. “Clinical research literacy is low. People don’t know much about clinical trials and are afraid of them. They need someone to explain it in terms they can identify with, someone who is from their community. I think it has to be a conversation with someone they trust—not a lecture from someone they don’t know. After all, this is your body we’re talking about.”
Within the disease-advocacy world, such training is starting to occur, to some extent. The Parkinson’s Disease Foundation trains people with Parkinson’s to educate their communities about the importance of Parkinson’s clinical research. Training takes place during an annual multi-day seminar. Some trained advocates are now working with investigators conducting the Coenzyme Q-10 trial.
As more HD drugs begin to work their way through the pipeline, Goodman is staying active in recruiting. She convinced some Seattle patients to head north to Vancouver to participate in a trial, and she’s working on amassing a cohort to be used for a registry for biomarker studies. “We have about 10 families already signed up,” she said.
“There was nothing for the last generation, but for this generation it could be different,” she said. “It’s my passion to try to speed that along.”