Dan Keller (00:08)
Welcome to this episode of Substantial Matters: Life and Science of Parkinson's. I'm your host, Dan Keller at the Parkinson's Foundation. We want all people with Parkinson's and their families to get the care and support they need. Better care starts with better research and leads to better lives. In this podcast series, we highlight the fruits of that research, the treatments and techniques that can help you live a better life now, as well as research that can bring a better tomorrow. Clinical research studies are central to developing new treatments that will ultimately improve people's lives, and in the case of Parkinson's, that may even slow down or halt progression of the disease. At the heart of clinical trials is the willingness of people with Parkinson's to volunteer to participate. Christine Hunter, the coordinator of the Parkinson's Foundation Center of Excellence at Baylor College of Medicine in Houston, is in close contact with study volunteers. She talks about what is needed to improve and speed up clinical trials, and why it's important to get involved.
Dan Keller (01:21)
Who does it benefit—the patient, the scientists, the community?
Christine Hunter (01:25)
Everybody. The more patients that we can involve in clinical trials, we can bring therapies to them much quicker. Part of the problem with clinical trials is the slow rate of recruitment into studies. So if we don't have people that are enrolled, it takes that much longer. So we want to bring new therapies, and some of them are very promising. Some may not be. Some we have to try to see if they're going to work, and we have to have the data to do that. But it helps everyone—patients, the scientists, the centers, the community—because as more people are aware and more involved, it's better for your health.
Dan Keller (02:05)
What kind of feedback do you get from participants?
Christine Hunter (02:08)
They love it. At least at our center, I have repeat participants, so they finish one study and then they go into the next one, depending on whether they're allowed or not. The Parkinson's Foundation has a registry also that they can participate in. So that's an ongoing thing that doesn't require intervention, but they're helping with data and the future knowledge of how the disease progresses, how we serve our people with Parkinson's.
Dan Keller (02:34)
You're at Baylor—that would bring up an idea of what kind of diversity do you get in studies, or is that lacking?
Christine Hunter (02:40)
I think it's lacking. It's lacking everywhere. In San Francisco, they have trouble with diversity in studies. Even though our cities are very diverse, we have one of the most ethnically diverse communities in Houston, but it's typically the same Caucasian participants. So we really do need minorities to step up. Things may be different for them, but we don't know that. And so until we have the opportunity to study with them and have them participate with us in studies, we don't know if there are ethnic differences, reactions to medications, all of those kinds of things that still have yet to be studied.
Dan Keller (03:15)
Do you think there are barriers or just not enough outreach?
Christine Hunter (03:20)
I think there are barriers. I think partly an outsider coming into a community—I think it usually has to come from within the community. Some communities are doing a great job at that. The Phoenix group has done a lot of outreach in the Hispanic community. They have done enormous work. And so I think there are some success stories, and so what we need to do is learn how to replicate those successes in other centers, in other communities.
Dan Keller (03:50)
Do you, I would say, market in a broad sense, participation in studies by telling people what has come out of patients participating in the past?
Christine Hunter (04:01)
Yes, we let them know whether they were on the active treatment or the placebo. After a study is over, we give them copies of the papers. A lot of the studies we do with the Parkinson's Study Group have webinars with the patients and participants to give them the data from the study, to let them know before it's broadly publicized. So there are lots of efforts to keep people involved and aware of what's happening. We go to our support groups. We go to different groups and let them know this study was positive. This is what you can expect. This is a new therapy that's just been approved. We have some other studies that are looking at similar things. As much information as people can have, then they can make an informed decision about what they want to do going forward. And I know sometimes the requirements for clinical trials are so narrow—the inclusion exclusion—people don't understand why we have such narrow inclusion exclusion. But to get a drug on the market, we have to go through so many different phases, and that broadens as they get larger. But the smaller studies, especially early on, they want to be very exclusive about who's put in a trial and making sure they don't have other comorbidities and that kind of thing. We want the success of the drugs. We want to be able to bring new therapies.
Dan Keller (05:16)
Do people get discouraged by the exclusion criteria? They're all hyped up to do it, and then they can't?
Christine Hunter (05:21)
Sometimes, sometimes that's a tough thing. Things as simple as weight. I mean, I have a funny little story. I have a patient who was ready to participate in a trial, and he went through all the screening and was excluded on his body mass index, but because the early studies were only done within a very narrow body mass index, he was excluded. His comment to me was, "I didn't know fatties couldn't be in a study," which—that's not the reason for that—but we did find another study that didn't have the same exclusion that he could participate in. So, you know, sometimes where they close the door, you've got a window that opens, and that's why the Parkinson's Outcomes Project is good, because everyone can participate. And so it's open to everyone, so everyone feels like they're involved in doing something.
Dan Keller (06:07)
Naturalistic, real world.
Christine Hunter (06:09)
Yeah, and do you receive physical therapy, speech therapy? Have you changed your medicines? What's going on? Have you been hospitalized? Do you have falls? Just kind of a global snapshot once a year to see how things are progressing in different categories, but it's been used to look at hospitalizations and to make some changes so people with Parkinson's aren't at higher risk when they're hospitalized. So there is good that comes out of everything. So I think that we're all in this together, and the more that patients can work with their centers, their nurses, their doctors, the more impact we will have on this disease.
Dan Keller (06:45)
Great. I appreciate it. Thanks.
Dan Keller (06:56)
There are lots of factors to consider when you are thinking about participating in a clinical trial. To learn more about what's involved, or if you want to find out which trials are currently enrolling participants, call our toll-free helpline at 1-800-4PD-INFO. To recruit enough volunteers, many trials involve several medical centers and medical practices around the country, so there may be trials starting or going on near you. You can also visit clinicaltrials.gov to look for studies in your area. One ongoing study Christine mentions is the Parkinson's Outcomes Project, started in 2009. It is the largest ever clinical study of Parkinson's disease, with about 10,000 people enrolled. Tracking so many participants over time allows researchers to examine the most effective Parkinson's treatments, benefits of various exercise programs, best candidates for treatment, the disease's impact on caregivers, and more. To learn about this study and other Parkinson's Foundation initiatives, listen to our podcast episode, "The Parkinson's Foundation's Role in Improving Standards of Care." If you have any questions about the topics discussed today, or if you want to leave feedback on this podcast or any other subject, you can do it at parkinson.org/feedback. We'll respond to some questions in future episodes. At the Parkinson's Foundation, our mission is to help every person diagnosed with Parkinson's live the best possible life today. To that end, we'll be bringing you a new episode in this podcast series twice a month. We'll continue our focus on research and how people can volunteer in upcoming episodes. Till then, for more information and resources, visit parkinson.org or call our toll-free helpline at 1-800-4PD-INFO—that's 1-800-473-4636. Thank you for listening.