The Role of Regulatory Affairs in Advancing Alzheimer’s Research with Elizabeth Shaffer
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.
Shelley Moore:Well, I am so excited for today's episode because we are gonna be talking with Elizabeth Schaefer from regulatory affairs at the Alzheimer's Therapeutic Research Institute at the University of Southern California here in San Diego. And she's also the regulatory affairs manager for the Alzheimer's Clinical Trials Consortium, and she provides oversight of all the regulatory management for all of our clinical trials and research studies, ensuring regulatory compliance on all of our studies. She's responsible for the development of informed consent documents, regulatory health submissions, the central institutional review board submissions, and registration of trials on the clinicaltrials.gov site where everybody can find out how to participate in our research. She's also a member of the participant alliance and task force for Participants First subcommittee and the National Institutes of Health Law and Ethics subgroup for genetic and biomarker disclosure work. The group puts participants first, and you're
Mickenzie Vought:going to hear about that work in today's episode. I loved this episode. It was so fascinating to get to know Elizabeth a little bit more and also just hear the ways that her and her team are making this work more equitable, efficient, and advancing research at a faster rate. It was so fascinating to hear the role that regulatory does play in keeping participants informed. And I think the biggest takeaway I had was around the research participants alliance and how important it is to bring in participants who are in this process to provide their feedback when it comes to consents, and advancing this research.
Mickenzie Vought:So excited for you to get to meet Elizabeth. Let's jump in.
Shelley Moore:Wanted to see if you could tell us about your journey to becoming the regulatory affairs manager.
Elizabeth Shaffer:Yeah, happily. Thanks. Thanks so much for having me. So I was brand new fresh out of college. I had gotten a job at a molecular biology lab, and I thought my future was lab based.
Elizabeth Shaffer:I thought I was going to be behind the bench and doing lab things. I had some background in administration and I knew that the person I was working for was like not a kind person. And so I left that position and went off looking for another job. And I couldn't get a lab job for the, to save my life. It was really impacted.
Elizabeth Shaffer:I didn't have the experience needed to really break into the field. UCSD pumps out a lot of lab qualified individuals, and I was not one of them. And I applied a bit on a whim to work at UCSD. And Jeremy Pizzola, who's the director of HRI now, interviewed me and hired me at UCSD. And that was back in 02/2004, and with for a contracts travel position.
Elizabeth Shaffer:I had a little bit of a background in both of those, and he hired me based on those qualifications. And I thought I was going to be there for maybe a year, maybe two. I thought it was just going to be a blip I could get my feet back into a lab job. And within the first year, I think Jeremy could tell that I was not long for that type of position. And he asked me what I wanted to do.
Elizabeth Shaffer:What else interests you? And he offered me sort of two ideas, doing sort of programming and site payments or regulatory affairs. And he so much supported me that I was able to take a programming class through a community college here to see if that was something I was interested in, really supported whichever journey I wanted to take. And ultimately I went with regulatory because I really loved the woman who was my boss. I thought she was brilliant.
Elizabeth Shaffer:And that's where I ended up going. And I have been in regulatory ever since. And that was in 2006 when I started working with her. So that's that is how I ended up in regulatory. And I it wasn't a world I knew existed.
Elizabeth Shaffer:And I fell in love with it very, very quickly. I fell in love with what we were doing to advocate for participants. I fell in love with the work that we were doing when writing consent forms. I love the detail orientedness of having to make sure that all of the right documents were in place and all the forms were done appropriately and correctly. You gotta be a little bit of a special type of person if you like that kind of detail in your life.
Elizabeth Shaffer:And I did, and I fell in love with it. And then the other side of it that really got me into this space was our former director, Leon Thal. He made me feel like, even though I was pushing papers on the back end, which is truthfully what a lot of regulatory is, is a lot of paper, that I was contributing in a meaningful way to Alzheimer's research. And I had never had a job that made me feel so connected to a purpose, to an end goal. And that's how I stayed.
Elizabeth Shaffer:I fell in love with the research and the people we worked with and what we were doing. In 2014, she moved on to another position, and I was offered the role of the regulatory manager at that time. And I was terrified. I'm pretty sure I cried because I didn't think I could do it. I was overwhelmed by the pressure of it, but Jeremy and the former director of administration really had a lot of confidence in me and supported me in that role.
Mickenzie Vought:Yeah, I think even in our pre interview and having conversations in advance of this, what I took away was really that importance of the linchpin and how you are standing in the gap and really advocating for the participants. And so I would love for you to hear you said that very early on, that they spoken to you and said, Hey, this is important, and you are advancing Alzheimer's research. So how do you see that? Well, how would you communicate that to people of why regulatory is important to the overall research process? And what is regulatory?
Elizabeth Shaffer:Yeah. So our world and regulatory and academic regulatory is we are a bulk of our job is writing the informed consent forms. So the consent, the document that participants sign before they agree to join a clinical trial, that is at the heart of what we are doing. And so it's our job to make sure that the research protocol can get translated into a reasonable person language so that you can understand the trial that you're entering, the risk and benefit, and really what what will it look like for you as a person to join a clinical trial. That is the huge bulk of what our job is.
Elizabeth Shaffer:Yeah.
Shelley Moore:And those risks and benefits can be intimidating in this work. And I'd be interested for you to share a little bit about how that process has changed over time as we've made progress in the field, what you've seen.
Elizabeth Shaffer:It continues to change. It's I'm trying to think about, the one of the first big studies we worked on was probably the A four study with Lilly. And the biggest oh, I thought was most interesting at the time is the first preclinical asymptomatic clinical trials. And we had to explain to our review boards, our IRBs, that this was a trial for people who didn't have symptoms, but was for Alzheimer's. And that was an interesting and a confusing thought because it had never been done before.
Elizabeth Shaffer:So we had to explain why you don't require a signature from a legally authorized representative. Well, non demented, asymptomatic individuals who we think are at risk for getting Alzheimer's, but are otherwise not experiencing memory problems. That was a really interesting shift in our field that had never been done before. So that was for me an incredible learning experience to be a part of that and explaining to so many different IRBs. I didn't expect an IRB to be confused by what we were doing, but I was so young, I didn't know it had never been done before.
Elizabeth Shaffer:Other shifts that I'm seeing in the field are just using less scary language, perhaps, really advocating and fighting for participants to have less legalese sounding language on our consent forms. How do you translate drug risk language into what we call the reasonable person language? What would a reasonable person want to know about this drug? How do you make it sound less lawyer y, less like the document you're signing is less of a contract and more of something that's informing you as a person about what the trial means.
Shelley Moore:That's great. And you mentioned IRB several times. And can you tell us what that is and what that looks like for your work?
Elizabeth Shaffer:The Institutional Review Board, IRB. They are tasked with overseeing the safety of participants for all human subjects research. And in broad terms or broad brush, I would say that every academic institution has their own IRB that oversees the research, the human subjects research, at their institution. And so back in the A four days, we had 59 participating sites and 59 IRBs that reviewed the research. Biggest shift in
Mickenzie Vought:our
Elizabeth Shaffer:Oh
Mickenzie Vought:my goodness.
Elizabeth Shaffer:Has been the shift to the single IRB mandate from the NIH that says that you have to have one IRB reviewing the research for all participants. And that has been a huge, huge shift in our field that went into effect. And I want to say 2015 is my best guess. 2015, '20 '16 is when we really started to implement the single IRB mandate from the NIH.
Mickenzie Vought:I'm fascinated by the idea of being really intentional around language. And as someone who has worked in content, and marketing, and been on the front end of just knowing how much language matters to people, I would make up that walking into an environment like this language would be really important. How do you ensure that you can find that relationship between communicating it and medical terms and communicating it in terms that a participant can get it, and even in words that they themselves use? So twofold, I think I
Elizabeth Shaffer:have the benefit of I don't have a medical degree. And so if it doesn't make sense to me, it's not going to make sense to somebody else. And so first and foremost, I want to make sure that it makes sense to me. Could I explain this study to someone in my family, to a friend who's outside of our bubble, who doesn't have the same acronyms that we all have? Doesn't make sense to me.
Elizabeth Shaffer:So that is something that I think about when I'm approaching every consent form. Can I explain it? I will explain it to my husband. This is his trial. Does this make sense?
Elizabeth Shaffer:Perfect. And what doesn't make sense to you? How do we explain it better? And then the other thing that we do now and has been an ACTC initiative is having it reviewed by actual research participants and people who are in the field of research from a participant perspective. And that's the initiative that Sarah Walter with ACTC led, and she leads our Research Participant Alliance.
Elizabeth Shaffer:Used to be the Research Participant Advisory Board, and they are the Research Participant Alliance. And so these are research participants who have been in our clinical trials, who have been in other clinical trials, and they will read my consent form and give me brutal, honest feedback about it. And it is the best thing that has ever happened to me. They are amazing. They will advocate for what makes sense to them.
Elizabeth Shaffer:What do they want to know as a participant? Because ultimately that's- they're my audience, and I'm not a research participant in the study. As much as I will advocate on their behalf, I will never have the perspective that they have as they're renamed my consent forms. So that's the other approach now that we have. All of my consent forms get read by our research participants, and I get the direct feedback.
Elizabeth Shaffer:And I will put that immediately into our consent form. And that has made our consent forms so much better.
Shelley Moore:And tell us a little bit about, maybe what has been the most surprising thing that you've heard from a research participant in feedback for some of your work?
Elizabeth Shaffer:Yeah. A couple of little things. We used to use the word experimental research study because it was on paper more eighth grade friendly. Hated it. Don't use experimental, use investigational.
Elizabeth Shaffer:Oh, absolutely. It was something that we just hadn't, you know, we try to remove words that are a little higher level and try to make everything accessible regardless of educational background. And that was one of the words that they took out right away. How much more information they wanted me to add into the consent forms, I figured it would be strip it out, make it shorter, make it cleaner. They wanted more information, like overexplain everything, which I continue to have to point out, you know, we're making our long consent quite a bit longer now, absolutely, but that surprised me as well.
Elizabeth Shaffer:And then it shouldn't have surprised me, but their feedback is the most powerful feedback I can take back to a sponsor. If I present to a sponsor, I don't think that the way your risks are presented is great, I think we can do better. The weight that I come back with and say, our research participants do not like the way you've ordered this immediately triggers change. They have such a powerful voice, which empowers me to go back to our sponsors and have direct and immediate change in our consent language.
Shelley Moore:That's wonderful. It's so exciting. And I know it's really changed our work. What is, the most exciting thing in your work today? I know it's obviously working with participants, but is there something else that gets you, like, really going in our field?
Elizabeth Shaffer:Well, so yeah. So seeing the new drugs that have been approved is is, of course, the most exciting thing that has happened, you know, for For two decades, I've been working in this field. And to see drugs actually get approved in my lifetime has been incredible. I spent decades of negative results, negative results, negative results. So that has been, of course, incredibly helpful and incredibly exciting to be a part of that and see the impact on our studies because of these approved drugs.
Elizabeth Shaffer:And then I would say the second biggest thing for my world is the introduction of biomarkers to help us reduce the number of PET scans, to find individuals who have biomarker blood tests that show a likelihood of having amyloid in the brain. And then that means that you're one likely to be qualified in the study. Then hopefully in the future, we won't even need to do PET scans for amyloid positivity. We'll just have blood scans. So that that has changed our field dramatically.
Shelley Moore:Yeah. That's interesting. I always was struck by the fact that when we were explaining risks around PET scans versus the cerebral spinal fluid taps and, so is that making it more accessible from the participant's point of view in your opinion, or is it just different complications now? Because now we have approved drugs, and that's a whole different kind of risk. Right?
Elizabeth Shaffer:I, Yeah. I don't know that the introduction of the blood biomarkers has changed the way we communicate risks to participants, but it is another point where we can help an individual understand that we're gonna make sure you're the most qualified to be in the study by taking this extra step.
Shelley Moore:That makes sense. That makes perfect sense. But, yeah, I do wonder about how you're feeling with the complexity, you know, when I hear about it. If somebody is already taking these drugs and they wanna still participate in research because while the drugs are great, they're still only, you know, a small percentage. So are you seeing a lot of interest and still continuing with research while on drug?
Elizabeth Shaffer:Yes. Absolutely. Yes. So and it's changed our approach to trial design. So you can't say anymore that you can't be on these drugs to be in the trial because you're impacting clinical care.
Elizabeth Shaffer:And so if someone is medically qualified to be on these drugs, you can't take someone off of those drugs or to be in the trial. And our trial designs have to accommodate for that. Now you have to have an allowance for somebody to be on some of these drugs to be in the study. So maybe it's going to be three months stable the way you would any other medication to be in these studies and on these drugs.
Mickenzie Vought:Yeah. And as the advances are happening within the industry within even your own research, like if it's a longer study, how often are you having to go back and revise and revisit the consent forms, the procedures, the agreements, what does that process look like?
Elizabeth Shaffer:Every time there's a new drug approved, we have to modify the consent forms. And so it's it is so much work, but for the best reason. So in a consent form, you're required to tell people about alternatives to being in the And when I started this, there were no alternatives to being in the study. There are no drugs for the treatment of Alzheimer's disease. And so the consent forms, every time a new drug gets approved, we've got to update our consent forms and tell participants because it's important.
Elizabeth Shaffer:There's another drug that's been approved, and maybe you're going to qualify for it. And you should consider whether or not that means you want to leave the study or continue in the study. And making sure that you are informed and you know that as they're being approved is part of our job to make sure that a participant is fully informed of changes in research and changes in drug approvals. Anything that would impact someone's willingness to be in the study, you've reconsent. It's a lot of revisions.
Elizabeth Shaffer:Yes. But but again, for the best possible reason.
Shelley Moore:So in in that part of it, how do you see your role advancing the speed, you know, the way we make these trials more accessible for everyone and also the efficiency of our research?
Elizabeth Shaffer:Our role is ensuring that that information gets out to all participants in a timely manner. And so I talked a little bit about how we have a single IRB, you have one IRB now that oversees your research. And so that, in and of itself, has increased our ability to update consent forms and push it out to all sites in a very quick turnaround. Within, you know, three months, we can get all of our sites with new consent forms and out to the participants in a timely manner. Back in the pre single IRB world, that could take over a year to get all of the consent forms updated and that information out to participants.
Shelley Moore:And your team's really grown. You've grown in this role, and now, you know, with you, we started working together. It was just you and a couple others. So talk about how that's changed for you.
Elizabeth Shaffer:I have a wonderful team. We have five individuals who work with me. So we are a team of six. I think we are the best team, obviously. So we have a great, wonderful team of individuals who care about the details, care about the nuances of the regulatory, the paperwork side, the consent side, interfacing with our sites and our IRB.
Elizabeth Shaffer:They are so passionate and so lovely at what they do. I'm really lucky with the team that I have.
Shelley Moore:That's great. I love that. That's wonderful.
Mickenzie Vought:As I'm wondering about the consent process, I'm fascinated to kind of think about it from the participants point of view a little bit. And I think my understanding was, okay, I'm agreeing to be a part of this trial, I will fill out one consent form at the beginning, and that will be it. But in conversations and preparations for this interview, I've discovered that there are several layers of consents, additional different aspects of it, how many consents on average, does someone kind of walk through and to stay educated of what they're agreeing to throughout a trial? If it were a longer trial or a shorter trial?
Elizabeth Shaffer:Yes. So of course, the longer the trial it is, the more chance that things will change over the course of the study that will mandate every consent. So for one of our studies, there's a two stage consent process. You have your first screening consent form, where it talks about all the things that we're going to do to make sure it's safe for you to join the study, that you meet all the requirements for being in the study. Then you get sent into what's your trial arm, which trial arm do you qualify for?
Elizabeth Shaffer:And then you have to sign another consent that's going to talk about that And what does it mean? Now you've been selected for this trial. What does that mean for my participant visit? What are the risks of the drug that I'm going to be on? So there's a two stage consent process.
Elizabeth Shaffer:And then anytime we get new information about the drug, you learn more about the drug, the more it's in research trials, and especially now that the drug drugs have been approved. And so as you learn more and your risk profile for your drug changes, you are responsible for ensuring that participants in your research study get that information as well. And so those can happen annually. We might get new drug information that will then get pushed into a consent form, and you re consent your participants to make sure they know at all times about changes in risk. Anything that will affect your consent to be in the study changes your risk benefit ratio.
Elizabeth Shaffer:We know new information now. We we are sharing it with you now.
Shelley Moore:So I wanna share a little bit about the scope and size of the work that you do. You have a great team and and the reason for that being can you just tell us the reason for that being the number of trials you're working on, the number of sites in each trial, the length of those, just to put it in perspective. So maybe that's coming from the number of participants that you're consenting in trials?
Elizabeth Shaffer:It's definitely driven by the the size of the trial study. So let's say we've got six different clinical trials. I've got my team members in general have two studies, two to three studies that they're working on. And all of our studies are large multicenter clinical trials. And so for each study, then maybe we've got 70 participating sites.
Elizabeth Shaffer:Each study is going to have a couple consent forms, and it's my team's responsibility to review 100% of those consent forms, both at the time that the site looks at them, modifies them for their institutional requirements. Sometimes there's a back and forth between our sponsor. And so they are reviewing 100% of the consent forms for every site for the duration of the study. So it's hundreds of consent forms they're reviewing just at the outset of a study. So it's a huge volume.
Elizabeth Shaffer:And that's just one piece of it. We're also collecting all of the required documents that you have to sign and collect to make sure that it's done according to all FDA regulations and in compliance with all ICH GCP regulations. So we're getting CVs, we're making sure that investigators are well qualified, we're collecting licensures and various certifications tied to the conduct of the trial. And that's across all of our studies. And it's huge volume, huge volume of paperwork.
Mickenzie Vought:That's a huge scope.
Elizabeth Shaffer:Yeah.
Mickenzie Vought:I think earlier in this series, we talked kind of on the other side of that of making sure that all the sites have similar protocols, and it feels similar and the processes kind of line up. And I just continue to see like your role being an additional aspect of that of making sure that someone would have a very similar experience no matter which site they were at
Elizabeth Shaffer:of those 70 sites. Yes. Also direct result of the single IRB mandate. So when we had 69 different IRBs, every institution, every IRB changed the way the information was presented to participants. Some of them were very good, some of them were very bad.
Elizabeth Shaffer:And we saw everything in between. With the single IRB mandate, it ensured that the same consent form was presented to every participant and that information was presented equitably. And so you weren't, not that you would know that you were being punished at a site that had a very bad consent form, but the way that you got information was presented quite differently than a neighboring site down the road. It was very highly variable based on the sites. And the single IRB mandate has really enforced this idea that information should be presented equitably to all individuals regardless of where they're located, what what institution they're tied to.
Shelley Moore:And so what do you wish people who aren't yet involved or don't know what we do? What is the one thing you wish participants knew about the research process?
Elizabeth Shaffer:I wish there was a way that we communicate how much we care about every detail going in from trial design, how much we agonize and debate every decision that goes into the, everything that goes behind the scenes to get to the point where we have a consent form that's in front of an individual. I've continued to be impressed and amazed by how much this field, our group and beyond our group, cares about the research so passionately. And I think you don't see that if you are completely external. There's, I think, maybe perhaps that sort of negative perception about drug companies, but we get to work with these individuals and their research scientists, and they care so much about this disease and making progress in this research. And it's not a, you know, a big CEO lining their pockets there.
Elizabeth Shaffer:Brilliant scientists working together across the cross platforms to move this field forward. And if you're external to that, you just don't see that. And I wish I wish people knew. We are trying so hard. Every decision is thought through.
Elizabeth Shaffer:And a lot of work goes into that moment before you're sitting in front of a person with a concept form.
Shelley Moore:That's great. I'm glad you shared that.
Mickenzie Vought:Yeah, I think that's the reason we're doing this podcast. I have just been so grateful for this series as we've gotten to get the inside scoop and connect with actually the people on the other side of that, right, the people that participants may not interact with or get to know on a daily basis. And I just see so much love and care, and really passionate purpose for this work coming from every single person we've talked to. So for you, Elizabeth, what has kept you at atri? What has kept you in this work and continuing to be a part of this larger mission?
Elizabeth Shaffer:Absolutely, the people that we work with has kept me in this field. I had mentioned how Leon Thal allowed me to feel like I was contributing to research. Paul Eason does the same thing, His ability to really truly make you feel like you are contributing to the research questions or answering on Alzheimer's, regardless of your role, is what keeps him here. And then the trust that this organization puts in me, I feel very supported in the decisions that I'm making. If I'm advocating for a specific change in a consent language or even a trial design, I feel quite supported by our leadership to implement change.
Elizabeth Shaffer:And that keeps me absolutely going. But the people 100% keep me here.
Mickenzie Vought:What is one of the things that you've been able to achieve over the last ten plus years in this field and with ATRI that you're the most proud of?
Elizabeth Shaffer:It's nothing that I can ever take credit for. But what I'm most proud of in our field is returning the shift to return research results to our participants. And that has been a decade long effort, driven significantly by our research participants who advocate for this and empower us to advocate on their behalf. When I started in this field, you returned nothing to participants. It's research.
Elizabeth Shaffer:We don't know what it means. It's not meant for clinical care, and everything was kept away from the participant. Even though our mission is to share data broadly, to make sure that all of this data is made available to investigators around the world to further research, to further science, we weren't giving research results back. And that has been a shift over the last decade to returning research results to our participants. And the fact that our researchers and our senior leadership have heard the voices of our participants, that this is important to them, that they don't care if you don't know exactly what it means, but give me something back.
Elizabeth Shaffer:And that has been a wonderful shift in our field. That's, I think, what I'm perhaps most proud of.
Shelley Moore:That's wonderful. That's really exciting. And so in terms of that, I think that also plays into how do you, include that in your protocols, and and how do you how do you do that? Because I'm sure there are some people who, like, don't want to know certain things and do want to know. So how does that play out for you?
Elizabeth Shaffer:I think importantly, you write it into your trial design. You make sure that from the outset, it's a consideration. What can we return to our participants about what we're learning about them over this four to seven years in our studies? You make sure that's in your trial design. You make sure it's described in your consent form so that someone knows that they can learn their results.
Elizabeth Shaffer:You make sure it's optional. You don't force someone to learn something unless it's required for the design of the study. So you empower your participants to decide if they want to know, or if they don't want to know about specific research results.
Mickenzie Vought:Well, I think that's just fascinating question, Shelley, to think through the additional layer of consent, right? Do I actually want to know that information? And can I have autonomy over the information that's given back to me? Because yes, knowledge is power. But somebody should have autonomy and the knowledge that they're taking in.
Mickenzie Vought:So that's just such a fascinating layer of consent that I wouldn't have thought of. Yes. Thanks for it.
Shelley Moore:Yeah. And also speak to the big thing that people worry about, like, I'm out that can be locked into this, like, you know, or maybe I made one decision in year one, and I make a different decision in year three. Like, how does that work for participants?
Elizabeth Shaffer:Yeah. So you make sure that participants are aware that they can change their mind. If they're not ready to learn their results now, they can they can wait. They can decide they don't wanna learn now ever or in four years decide that, Yeah, now I'm ready to learn.
Mickenzie Vought:And does that apply to every level of the trial? Like I want to pull out in year two, or am I committing on the front end? What does that look like?
Elizabeth Shaffer:Right. So hopefully we are clear with our participants, they can discontinue opt out at absolutely any time. That research is voluntary. You are never in any space where you're obligated to continue. Once you agree, you can change your mind at any time.
Shelley Moore:And then also, think a lot of people don't realize, but talk about that it's not just the participant in this work. It's also their families. Families,
Elizabeth Shaffer:care partners, yes. In general, our studies will have a care partner, a study partner who participates with the participant. They will answer questions about their perspective. How are they seeing the participants' cognitive changes over time? So we ask questions about the study from your study partner about the participant.
Elizabeth Shaffer:The consent form for a study partner is much shorter. In general, we wouldn't view the study partner as a research participant, but they are informing us. They're a critical part of the trial design because they're informing us about how the participant is doing over time and are answering questions about the participant. It is a lot lighter and a lot shorter of a consent form, though. I think there's this three pages, three, four pages.
Elizabeth Shaffer:That's great.
Shelley Moore:So as we wrap up and look at how HRI is celebrating our ten year anniversary, what are your hopes for the institute's future for Alzheimer's research and yourself in this role?
Elizabeth Shaffer:My hope is always that we just continue to do interesting science, interesting research that furthers the field and across disease disciplines. What I love is that we can do studies that perhaps a drug company wouldn't be as interested in, but are scientifically interesting and will inform the field, and across all types of different disease progression disease stages. So I would be happy to continue to do interesting science that will answer research questions for the field.
Shelley Moore:So I I know that there's a difference between, like, our Alzheimer's disease neural imaging initiatives, observational study, and the a four trial, which you talked about before. Just from your perspective, has there been something that stood out a trial that stood out as the most interesting, or is it too hard to pick favorites because you work with so It
Elizabeth Shaffer:is it is really hard to pick favorites. So a four was interesting because it was the first of its kind, and it was a little bit of a renegade. Was new to the field, know, doing, were kind of felt like we were going, doing the best that we could as fast as we could. It was such an interesting time to be in that type of trial design. ADNI was a study that I started working on in 2004 when I joined UCSD, and it's still going.
Elizabeth Shaffer:And I continue to be blown away by the impact that that study has had on the field. The ADNI study releases all of its data in near real time to researchers around the world. And that was, it remains an incredible study to be working on. And the longer the study continues, the longer I'm in this field, the more you hear about the impact of the ADNI study on this field in a way that I didn't appreciate when I started working on the ADNE study. It wasn't until we started going to these large conferences and seeing data presented from the ADNE study and meeting research participants who'd been in the ADNE study since its start that you really get a sense for how impactful that study was.
Mickenzie Vought:And we've, talked about the ADNI study, I feel like on every episode so far, but will you remind us what that acronym stands for?
Elizabeth Shaffer:Alzheimer's Disease Neuroimaging Initiative. And it's an observational research study. They look at disease progression. You come in for every visits every year or every other year. They enroll individuals who have normal cognition, who have mild cognitive impairment, and who have dementia.
Elizabeth Shaffer:And they just follow them over time. And they make all of that data available so that people can learn how disease progression occurs from normal cognition to dementia. I love that we have drug trials and observational trials that you can find a study that works for you. If you want to be in research and you're not interested in being on a drug, there's an observational research study for you as well. Is there a
Shelley Moore:particular milestone or two that you would point to as the most impactful for the field?
Elizabeth Shaffer:For perhaps my field, 100% single ivory mandate changed my world, changed the way we present information to individuals. The and didn't get to talk about it, the revised common rule that mandated that information be presented to participants in a reasonable person standard, that you present information in the first page, first two pages, that a reasonable person will want to know before joining the study, before getting through this 20 page consent form. Those have been big milestones in the way that we present information to participants. And then for the field, in my world, the blood biomarker tests have been hugely impactful. And then, of course, having drug approved.
Elizabeth Shaffer:Drugs, plural, approved. And so drugs will continue to be approved and become safer and better. And you'll just keep seeing next generations of these drugs. And I think it's gonna be exciting, exciting next ten years. Wonderful.
Mickenzie Vought:Thank you so much, Elizabeth. This was such a fascinating conversation. And on behalf of everyone, we are just so grateful for the care that you bring to your role, the expertise and just your willingness and desire to make sure that your participants are educated and equipped, and have the autonomy to really opt into what they're agreeing to be a part of. So thank you.
Elizabeth Shaffer:Thank you.
Shelley Moore:Thanks for listening today. If you'd like more information, please visit us at atri.usc.edu. Thank you.
