Partnering with Research Participants for More Inclusive Alzheimer’s Research with Sarah Walter
Welcome to the Alzheimer's Research Podcast, a show reshaping and leading the conversation around Alzheimer's prevention, brought to you by the Alzheimer's Therapeutic Research Institute at Keck School of Medicine of USC. Whether you're a clinician, a researcher, or someone who wants to change their mind, these conversations explore the possibilities within reach to prevent and effectively treat Alzheimer's disease. I'm your host, Shelley Moore.
Mickenzie Vought:And I'm your cohost, Mickenzie Vought. Well, Shelley, I am so excited about today's episode, we got to sit down with Sarah Walter, and she is just absolutely fascinating. What I took away the most from this conversation was the importance of involving participants in the research process. And so I'm so grateful for the ways that she has really advocated for the participants at atri and for the consortium. And so, as we rounded out this interview, she talked a lot about the research partnership alliance that she has been able to do over the last few years.
Mickenzie Vought:And I was fascinated by it, and the direct impact that it has had on the way research is done, where the field is going and her hopes.
Shelley Moore:Yeah. Sarah is a wonderful, person, and and her work is just so inspiring. And I'm just so glad we we got to talk with her. You'll just really enjoy this episode. Alright.
Shelley Moore:Let's dig in. Welcome, everybody, to today's episode. We are really excited to welcome Sarah Walter, who is the program administrator for the Alzheimer's Clinical Trials Consortium for the Alzheimer's Therapeutic Research Institute at the University of Southern California. Her role is to ensure efficient operation of the consortium and foster collaboration both within the community and with external partners. Sarah leads the initiative to include research participants in scientific forums, chairs the ACTC Research Participant Alliance or the consortium alliance.
Shelley Moore:Sarah, you lead a lot of things, and you also led site and study metrics, establishing the neuropathology infrastructure as well as site process improvement, networking, and support. I could go on and on with all the things you do. I just don't even know how you juggle all of it. It's amazing. And you have such a long and deep history in this field and an interesting path in how you got here.
Shelley Moore:So I'm really excited to welcome you today and get into this. It's gonna be a great episode.
Sarah Walter:Thank you, Shelley. Thanks for including me.
Shelley Moore:So can you tell us a little bit about your role or how you got to this position with ATRI?
Sarah Walter:Well, thanks, Shelley, for the question. I love talking about how I got to where I am. I know that most of us come into clinical trials from different places. There isn't any kind of defined career path for clinical trials. And I like to tell my story especially to girls that are in high school or even junior high because as a student in school, I did not enjoy my science classes.
Sarah Walter:I never thought that I would end up working in clinical trials. I was very interested in psychology and sociology, that's what I ended up studying. So my brother, who's a physics major, called it soft science. He was into hard science and I was into soft science. But I had a very curious mind.
Sarah Walter:I asked a lot of questions. And so after getting my master's degree in gerontology, I got my first job in Alzheimer's research. And that's where I really fell in love with the people. I was so inspired by people living with the disease, their tenacity, their ability to overcome so much that was happening with their brains and to see caregivers too with their creativity, their flexibility, and their commitment to that individual that unfortunately had dementia was so inspiring to me. And then at the same time, I was working with scientists that really inspired me as well.
Sarah Walter:They persevered through all kinds of failures. Every study I worked on for many, many years was what we call a negative study, which means that the intervention didn't work. But I learned from those scientists that there's no such thing as a truly failed study because you are learning with every study that you do. So I did a lot of different jobs. Again, because I came from people science, from social science, I ended up doing work in operations.
Sarah Walter:I was a project manager. I got to work on the very first version of the Alzheimer's Disease Neuroimaging Initiative when that was established in 2004. I was the project manager and wrote the first protocol. That study has had an incredible impact on the field, so I just personally find it so rewarding to be able to witness firsthand the impact that that study has had and have been a part of it in my small way. And then I started working in data management, which wasn't really a great fit for me in terms of my personal interests, but I always saw our mission and our purpose underlying it all.
Sarah Walter:And that always pushed me to develop the best databases and make sure that data was perfectly clean and help inspire my team. So then this opportunity of being a program administrator for ACTC opened up, and I really jumped at the chance. My job now is to network with our full research site. Many of those sites I've been able to get to know over twenty years of working with this consortium. ACTC itself was funded in 2018, but many of the sites have been working together for thirty years even, since the very first clinical trial in Alzheimer's disease.
Sarah Walter:And it's really like a small family. They all really get to know each other. And so my role is to help continue that network, build that network, bring more voices into that network, listen to the feedback that our clinical trial sites are giving us, and then relay that to our study teams for all the studies that we're running. So that's what I'm doing now. And then as I mentioned to you in the outset, as we were putting together ACTC in 2018 and 2019, I saw that the requirements that the NIA had put out included single patient representative to sit on an external advisory board that met once a year.
Sarah Walter:When I saw that and my job was to make sure that we set up all of the committees and the governance for ACTC. So when I saw that, I asked Paul Aisen, my boss, if we could do more than that, if we could do better, if we could actually build an advisory board where we had ongoing meaningful feedback from people that have lived experience, not just people in our studies, but people that haven't even thought about research. Can we be talking to them on a regular basis? And then integrate that into our work. Because like I said, over the fifteen, eighteen years of research prior to that, we had never had that kind of direct channel of feedback on our studies, the way we set them up, the way we run them, and the way that we share information that we're learning from those studies.
Sarah Walter:So that has been just incredibly rewarding. And I love everything I work on, but that definitely has my heart.
Mickenzie Vought:I love that. Can you tell us a little bit about those early stages and inviting participants into that and how you structured it? I'm just super fascinated on was there a really big interest in becoming a part of this? Or was it something you had to build the momentum and get people excited about?
Sarah Walter:We had a lot of people sign up actually. Yeah, there was a lot of interest. So yeah, we what we did is we first saw input from other groups that had done similar work. The dominant inherent Alzheimer's network studies individuals that have familial forms of Alzheimer's disease. That's people that have a one hundred percent chance of getting the disease within a few years of when their family member got the disease.
Sarah Walter:So those are individuals that are living with very high risk. They know it and they're very motivated to take part in research. But that consortium is run out of Washington University and they've been close collaborators of ours for many years. And I had attended one of their family meetings where they brought people from their families, either people carrying the gene, not carrying the gene, people that actually have now dementia, people that don't, and set up this direct conversation between researchers and families. It was so powerful to see that.
Sarah Walter:And so I knew there were groups that had done something similar, but nobody had done it in clinical trials of Alzheimer's disease that I was aware of. So we were able to get some feedback from them and from the Alzheimer's Association. They have an early stage advisory board where they bring together people that are in early stages of symptomatic disease. So people that are just starting to, you know, they've just been diagnosed and they're starting to have symptoms. They advise Alzheimer's Association and they serve as ambassadors for research and for the Alzheimer's Association.
Sarah Walter:So they offered some guidance in terms of the logistics, how to make sure you set up a group that isn't too big, it's not too small. We needed to make sure that we had good representation. We're running national studies. We're running studies for people that have elevated risk. We're running studies for people that have symptoms.
Sarah Walter:We're running studies for people that are in end stages. So we need to be hearing from the voices of all of that. Plus, think about how different this disease is experienced if you're in a rural area, if you're living in a city, if you have family, if you're living on your own. So we have a really nice balance, I think, in in representation on our group. Impossible to serve all of those voices, but their feedback has been really, really rich.
Shelley Moore:And I've been so grateful to be a part of that alongside you, Sarah, along the journey. And I know some of it is also the the way you coordinate that group. Talk a little bit about the specifics. And I know it took some practice in terms of how you interact with them, but I just love how you went about that process of finding the perfect mix of people and how you come together. So just if you want to share just a little bit about that and what that looks like on a basis.
Sarah Walter:Well, I think the most important thing for any researcher that's trying to put together a group like this is to start from a place of humility. We do not know what it's like to live with the disease. We don't know what it's like to care, although a lot of researchers have experience in providing care. That experience is really different based on your socioeconomic condition and a lot of other things in life. I have a lot of one on one conversations with every member of our group.
Sarah Walter:We have 14 members right now, and that really has developed into very close friendships in many regards. But the most important thing is start from a place of humility and listening and plan on being flexible. Make sure you're supporting people that have cognitive impairment, that you're offering them options for how they can connect and how they can provide their feedback. Give people a lot of time to prepare, a lot of time to review materials. But as Shelley's seen over the years, we've definitely evolved.
Sarah Walter:I mean, we started out where we were almost assigning work to our group, like, here's your assignment, tell us what you think, to now where it's much more of a collaboration. And we're starting from much more open ended questions like, we've got this issue. What do you guys think about this? What should our priorities be? What are we missing?
Sarah Walter:And I think it's only with many years of close relationship building that you can get to a place where you get the really good feedback, and that includes hearing some some stories that are tough to hear. Yeah. Like, it's really tough to hear where researchers are falling short, where a participant has a bad experience. And I am so grateful when our members tell us those stories because I it shows how much they trust us that we're we're gonna listen to it, we're gonna do our best to make sure that doesn't happen again.
Shelley Moore:So how how have you seen that shift in terms of how it's received by involving research participants in in our work?
Sarah Walter:Well, I think that stories have a lot of power. And so I really try to, as much as possible, bring the stories directly from the mouths of our participants, whether that's through a recording or through them participating in a panel or bringing them in person to any of our scientific venues. That allows people to really hear firsthand those stories, get to know each other on a personal level. That builds trust and that allows those stories to penetrate in a way that they won't penetrate if I'm just typing up minutes from our discussion and emailing it to everyone and they just see bullet points from Sarah Walter. We, as researchers, need to hear those stories directly and be accountable, personally accountable to our participants to address the issues that they're bringing to us with our research.
Mickenzie Vought:Yeah, it's something that I gathered from a different interview that we had with Elizabeth was the weight that a participant's story and participants experience really does carry when it comes to writing procedures when it comes to changing things when it comes to improving or optimizing the process. There is a respect and an honor and even just so much appreciation I'm hearing from your voice for your participants that if a participant comes, you can say, Hey, this is direct feedback from our research partnership alliance, things change. Like I am really grateful to hear that and how much their experience does really impact the way that you go about your research. So that was something that I really took away from our interview with Elizabeth.
Sarah Walter:Yeah, I'm glad. Elizabeth's been an incredible partner and has been really actively working with our partnership alliance to get feedback on consent forms. Consent forms are such an important part of coming into a clinical trial. It's where you lay out everything and it's like the toughest job, I think, what she's doing. To write a consent form, you really want to make sure you're presenting all of that information.
Sarah Walter:You're being as transparent as possible. But consent forms are a big area where we get a lot of feedback. We just started our first Down Syndrome Advisory Board, and that has been an incredible I've just enjoyed every interaction I've had with our self advocates who are people living with Down syndrome and their care They're all moms that are part of it except one sister. But it's so exciting just to hear directly from all of them. And they've reviewed a few consent forms for some of our new Down syndrome trials.
Sarah Walter:It's a fantastic area to get input. But they've had input on our study logos, our study names. I think the biggest and most consistent area of feedback they've provided is around the sharing of individual research results. And so even from our very first meeting, they said, We want our own data back. We want to receive back our own data.
Sarah Walter:And in clinical trials, that has been a challenge because some of the data we collect, we don't know what it means clinically. So it doesn't feel responsible as a researcher to give someone a score on a cognitive test or a value in a blood panel. If we don't know what this means for your future and we don't want you taking this information and assuming the worst or for it being a problem for you even immediately or maybe even down the road. So those conversations have been really important. As we've partnered with them, the last five years of Alzheimer's research have just been astonishing.
Sarah Walter:The amount of learnings we've had, the amount of new findings. Finally, the advent of blood based biomarkers, which I don't know if I've told Shelley this story, but in my very first job was a biomarker study that I started working on in 02/2001, collecting samples for a biomarker study and for a researcher in London, England. And he told me, We're going to have a blood test in ten years. And I was like, Wow, you guys, we're going have a blood test in ten years. And it took a little bit longer, but he was right.
Sarah Walter:We have a blood test. And it's awesome. It's incredible that now, not only can we improve access to an accurate diagnosis now that we have a blood test, hopefully we can even open up the possibility of being in a clinical trial, even for people that can't reach a medical center where there's PET scans and MRI scans and expert cognitive testers. So I've been involved in our decentralized research, which is really centralized research. It's research that we do through the web using studies like the APT, the Alzheimer's Prevention Trial web study.
Sarah Walter:We have over 60,000 people that have signed up for this web study. Many of them come back for their quarterly assessments. We're rolling out a new cognitive assessment shortly for that called Branch, which we think is really going to be a wonderful way to understand if changes in cognition are happening and allow us to connect people to research studies in a much more relevant way. And I've led the AlzMatch project, which allowed us to test whether it'd be feasible for us to get a blood test at a local Quest lab. And that study was successful.
Sarah Walter:We were feasibly able to get over 2,000 blood samples collected from people from these web studies. So it's just a really exciting time to be involved in research, and it's just been a joy.
Shelley Moore:In terms of this long career path you've had, you've been seeing the ups and downs. From your point of view, what do you think has been the most important milestone in the last ten years since ATRI has been in existence?
Sarah Walter:I think the blood based biomarkers are the most important milestone, I would say. I mean, obviously having a drug that is approved by the FDA that actually does slow the disease down, that has been a huge milestone as well. So I think those are my two key milestones.
Mickenzie Vought:Two great milestones. Right.
Sarah Walter:But there's so much more research needed on both of those. I mean, they're good starting points, but we are not done.
Shelley Moore:So Yeah. What gets you most excited about for the future then?
Sarah Walter:You know, I think the thing I'm most excited about, Shelley and Mickenzie, is that we are able to now involve participants in our research. It's not only feasible to do it, it's the right thing to do, and it's the best way to do science. And I'm working on a project now where we are interviewing some of our AlzMatch participants to ask them what their experience was like so that we can learn from that experience and we can improve the way that we engage with people remotely because we know that is one way that we're going to be able to really increase how inclusive our research is, to make research more accessible using digital methods. It won't solve all of our problems, but it's definitely an important step towards inclusive research. Inclusive science is the best science.
Sarah Walter:I mean, that's the biggest drawback in what's happened with these new disease modifying therapies. They were approved on groups of individuals that don't represent the people that are most affected by this disease. And we have to make research more inclusive. We have to find ways to make research easily accessible for anyone in any walk of life. And I'm thinking primarily now about The United States, but that goes for global studies as well.
Sarah Walter:I mean, there's huge areas of our globe that are not represented in research.
Mickenzie Vought:Can you say more about how the drugs that have been approved for treatment aren't representative of like a fuller population? Just I'm fascinated by that. Would love to know what you mean by that.
Sarah Walter:Well, the groups of people involved in the studies were primarily white highly educated with high socioeconomic status. And that makes a lot of sense because being involved in these clinical trials is, you know, it's a huge commitment. It's a huge time commitment. You have to go to an academic research center. It typically takes four or five hours every time you go there, even if you live close by.
Sarah Walter:So you have to have time to do that. That means you're not caring for your grandkids, you're not still working. So you've got enough resources to know about the study, you've got enough resources to take that time off, and you've got the resources to feel safe and understand exactly how that study is being done and how your safety is being monitored. And those are all things that we just need to bring to the whole population.
Mickenzie Vought:Thank you. That makes a lot of sense. And with that in mind, I would imagine that there is a little bit of a barrier, even the fact of where a lot of the trials are going into like a collegiate environment, what are some of the things that you wish potential participants who might be intimidated by this or intimidated by another barrier that may be in the way for someone being hesitant to take part in research? What do you wish that they knew?
Sarah Walter:I think there's a real danger in focusing on the people that aren't volunteering for research and asking what is it in their minds that we need to change? So it's a good question, Mickenzie, and there's a lot of researchers that have written papers on that very question. But the problem with the question is it doesn't turn the question back on us. What is it about research that's so hard to access? What is it about medicine that makes people not trust medical research?
Sarah Walter:Medicine and research, like we have to fix us first before we can ask people to trust us and be part of studies. And part of that is, to answer your question, is showing up in communities, asking people what they think, and giving people what they want. Sharing back your results is one way to build trust and to say, Totally, we get it. You want to understand how your cognition is changing. Well, yeah, let's share those scores back.
Sarah Walter:And we'll have a conversation about whether that has any meaning for you clinically. So yeah, I think we can empower people in our communities. So that's our responsibility as researchers and as people in the medical field.
Shelley Moore:I love that. I love that you do that in everything you do, Sarah. It really it really comes through in your work. And you're constantly growing in your career as well. So maybe talk a little bit about where you're going, what you're working on now with your education, and what your hopes are for for your personal future path.
Sarah Walter:Thanks, Shelley. You know, I've had this wonderful opportunity to work with this great team of researchers, and I've had a lot of different jobs within the last twenty one years. So I'm grateful that I've been able to work with the same group basically, but I've been able to do a lot of different things. And as Shelley hinted at, I have just started a part time PhD program through the University of Edinburgh. Yeah, and I'm so grateful that ATRI is supportive of me continuing my education while working full time.
Sarah Walter:It's a lot to balance, but it's wonderful to get that support from your employer and from your team. So what keeps me going is as long as I can see that I'm having some impact, then I'm going to continue. I think all of us are looking for that meaning in our work, whether it's volunteer work, whether we're volunteering as a participant, whether we're working as a researcher. We want to see that we're having an impact. And so Shelley, that's what keeps me going.
Sarah Walter:As long as I'm seeing that impact, I'll keep going.
Sarah Walter:That's terrific. Yeah, wonderful.
Shelley Moore:Well, I really enjoyed this conversation and hearing about the willingness to make changes and all of that. And kind of just have gone back in my head to that question about how do we make changes within the research process that makes it more approachable. So what are some of the shifts or changes that have been made over the last five years or so since doing that, that you can say, Okay, I know that my participants had a direct impact on how we do science and how we are changing the way that we go about this to have better science?
Sarah Walter:Ideally, when you're working with a partnership alliance like this, you want to involve them early in the design of the study, because the earlier the better. And when we first got started, the studies that we were getting their feedback on had already been put together. And so we were getting their feedback, but many of the things that they offered as suggestions we weren't able to integrate. And so I see that as a key part of my role of I'm constantly going back to their feedback and raising that feedback again in any of our study design discussions when we're discussing new ideas or new initiatives. So what's important too for that group is they want to see their impact.
Sarah Walter:Sometimes that impact can be measured. Like one of our first meetings, they said that the study partner so most of our dementia studies require, even if you don't have any changes in your cognition, that you have a study partner. That's somebody that comes with you to the visits that can tell the researcher if there's been any changes in your memory or your daily functioning. So study partners are really important to every research study because every research study includes the participant and the study partner. But for most of our studies up until this point, we had not provided any kind of financial reimbursement to the study partner for their time.
Sarah Walter:And so that was one of the first things they suggested. You guys have to give a reimbursement to that individual as well as the participant. It doesn't make any sense. So I mean, that was kind of a, oh, duh, we definitely need to do that. And now I'm seeing that that's much more standard in our studies is that we're always offering reimbursement to both the participant and the study partner.
Sarah Walter:So that was one concrete thing. Again, the sharing of individual research results, that's something they've been asking about. But once your study protocol is finalized, it's really tough to make those changes and get that worked in. But what I saw happening is they would provide that advice for our head study, that head study had already been finalized, so we weren't able to make that change. But when the A four study closed out, the research team proactively planned to share whatever information we could back to those participants.
Sarah Walter:So advice on one study impacted practice on another study. And I think the other thing that's really tough to measure, Mickenzie, is just shifting perspectives in the researcher themself. So when you go to set up a research study, are you even thinking about giving anything back? Well, what I've seen is a shift really happening where it was not even thought about or if it was thought about, it was like an afterthought. Now it's being thought about from those earlier stages, which means now you're going to have enough resources dedicated to it, enough planning and thought around the sharing of results.
Sarah Walter:And it means that participants are just going to have a better experience. So it's tough to quantify, but that's one of my goals is to try to quantify to anytime I hear someone say, we're going to do this in our studies, I write it down and I text my advisors and tell them, you guys, your voice is making an impact because I know they need to hear that just like I need to hear it.
Mickenzie Vought:Thank you for sharing that. That is so encouraging. I'm glad there were so many tangible examples. And what I'm hearing is, throughout this process going from like, okay, you it's an afterthought to even have participants feedback in it one person at least two, we are intentionally bringing them in at the front end to design our studies to make sure that it is an approachable and a good experience for them.
Sarah Walter:Absolutely.
Shelley Moore:Yeah. So Sarah, if somebody you know, is hearing this, and they're, they're thinking, gosh, I have a lot to share too. Do you have any advice you would offer to folks, about getting more involved and giving feedback to researchers?
Sarah Walter:Well, I would be happy for any participant to reach out to me if they have feedback or would like to learn more about how they can get involved and partner with researchers to improve science. I'm happy to do that. You know, one of our goals is to build capacity of any of our participants who really want to engage on that level that want to get more involved. One of the ways we do that is inviting them to scientific conferences. We've been able to run the AAIC, which is the Alzheimer's Association International Conference.
Sarah Walter:We've been running that program since 2020, inviting people from all walks of life to just come and listen and hear firsthand what's happening in science. And then we offer support with small groups because, you know, throwing somebody into the deep end into a scientific conference isn't always an enjoyable experience unless there's people like you that you can talk to about like, well, what did you get out of this session? What did you think about this? Or even have a place where they can ask questions or get clarification.
Shelley Moore:So anybody who wants to get in touch with us can reach out through our website, which is at atri.usc.edu.
Mickenzie Vought:We've been asking everyone in these interviews as ATRI celebrates their ten year anniversary, you've talked a lot about where you want it to go, where you want the science to be what you're excited about. What are your hopes for the institute's future and Alzheimer's research in general?
Sarah Walter:I it's more than a hope, it's a confidence. Know that ATRI will continue to push the field forward, that we will challenge the field by designing and running the most innovative trials, that we will do research in the best possible way with inclusive science and including our participants as partners in our research. So it's more than a hope. I'm excited for the next ten years of ATRI and I'm very proud to have been a part of the first ten.
Shelley Moore:Thank you, Sarah. This has been really phenomenal and and just really glad that we had the time with you today. Thank you so much for giving us this time and sharing your story.
Sarah Walter:Thanks very much, Shelley. Appreciate it.
Shelley Moore:Thanks for listening today. If you'd like more information, please visit us at atri.usc.edu. Thank you.
