Episode Transcript
[00:00:00] Speaker A: One of the things that I see is not thinking about the experience as a whole. What would we need to do differently? That means not taking your long form consent process and just sticking it in an app.
[00:00:17] Speaker B: Hi everyone. Excited to be here for our Power to the Patient podcast and excited to welcome Katie Baka Mots from the Scripps Institute here today with us. We are going to be talking to Katie about her career in clinical research and patient centricity as a focus. So let's get started. Hi Katie, nice to have you here.
Tell us a little bit about yourself and your role at Scripps.
[00:00:49] Speaker A: Yeah, sure. Thanks so much for having me. It's great to connect again and great to be here talking about some of my favorite topics. So that's always fun. My name is Katie Bakamotz. As you said, I've been with Scripps Research, which is a nonprofit organization out of La Jolla, California, near San Diego, for about nine years or so. Working with the translational institute out there under Dr. Eric Topol. I got into clinical research on one of the very first direct to participant clinical trials. That was my first, so it was already innovative. So I kind of jumped right in.
Some work with Dr. Topol and Dr. Steve Steinhubel, who were running the MSTOPS program at the time. It was an AFIB Detection in the wild program that we were doing in partnership with Johnson and Johnson and Aetna. And then it all took off from there. I've done some work with the all of Us research program, which is run out of the National Institutes of Health, and then co founded the Scripps Digital Trial Center a few years ago where we've done a lot of work across different therapeutic areas, all with the eye on patient centricity, as you talked about. And I know you guys do a lot at Power, so we're big fans of that as well.
[00:02:04] Speaker B: Thank you. Thank you. No, that's exciting. I mean, I love your background and we'll get more into that. But first, would love to learn a little bit, especially for our listeners, about the role of the Scripps Institute. I mean, it's celebrating its centenary year this year and really what its mission is. And then if you could talk about really what were some of the key objectives with which you established the Digital Trial Center?
[00:02:35] Speaker A: Yeah, so as you mentioned, Scripps Research, we're having our big anniversary this year, so it's pretty amazing. For those of you who don't know Scripps Research, it was actually founded by an amazing female philanthropist, Ellen Browning Scripps 100 years ago and she donated tons of money across the San Diego region and elsewhere to really promote science, among other things.
Scripps research is largely basic sciences, so we've had a lot of work in biology and chemistry. I actually sit within the Translational Institute, which is really meant to bring all of that science out into the real world, bench to be bedside, if you will. The Translational Institute, as I mentioned in my introduction, was started by Dr. Eric Topol. Those of you who are in the digital health space in AI might know of Dr. Eric Topol and all of his wonderful work. But under the Translational Institute, there's three major areas. We have AI and machine learning, genomics and then digital medicine. Our digital medicine group, where I sit is really looking at ways to advance both healthcare using digital health technologies, smartphones, sensors, wearables and other types of real world data capture to advance health outcomes. And it's also helping us look at the way that we transform the way that we do clinical research. So that's where we started with at the Digital Trials Center. So when I came onto Scripps, as I mentioned, we were working on one of the very first direct to participant clinical trials. I mentioned it was the M Stop study. I came into it just from a behavioral science perspective. I had been working at places like Disney Research doing consumer behavior type of studies. I got introduced to Dr. Topol and Dr. Steinhopel because they had everything, everything was set technically to do this study remotely. You could contact the patients, you could send something in the mail, they slap it on, we monitor them for several weeks. Everything was set, but recruitment flopped. When they sent out these letters, nobody responded. And so that was really the way that I got into clinical research is I came in and I said, katie, this sounds like a behavioral science issue. Can you help us figure out how we can do do clinical research and get people involved in it? And so I did some basic A B testing and we tried to figure out motivations and tried to figure out how to reach patients. And that was kind of the first part of the digital trial center is how do we advance the way that we're doing clinical research to really embrace the digital, to embrace new technologies, new tools. And then we got a grant from the National Institutes of Health to run the participant center for the all of Us research program.
That is a million person cohort that is being built multimodal data that's really meant to advance biomedical research. And so it aligned well with Scripps goals.
And that really our goals there were how do we bring in digital health technologies into the program, but also how do we recruit anyone anywhere? Because as that program launched, they said anybody, anywhere living across the United States should be able to contribute to and benefit from this research program.
But you can't do that. As you guys know at Power and Step, you can't reach everybody in the traditional way. You can't reach everybody if you only use academic medical centers. So our job, and I know this is a very long answer, but our job was to develop that infrastructure, both the technical infrastructure, the partners, the know how of how do you complete a protocol end to end, something like the all of Us Research program, which is a large observational research program anywhere in the country. Doesn't matter if you're in rural Alaska or, you know, in urban centers. And once we had that, and this is where I come back to, how did we launch the digital trial center? Once we had put in the blood, sweat, tears to build that up, we realized we had something pretty powerful and we could take that infrastructure, those partners, that network, and launch the digital trial center, which supports a number of different research initiatives across the country.
[00:07:17] Speaker B: And all of this was prior to Covid, or I'm assuming happened, you know, and obviously Covid changed a lot about how I think all of us need digital lives. So, you know, what to you has changed now that more participants. I mean, we've seen that some of that with power as well. Like what have you seen and how people's perception about, you know, accessing research remotely, participating in maybe decentralized trials has changed. You know, in the last seven to.
[00:07:49] Speaker A: Eight years, so much has changed. I mean, if you look even a decade ago, the fact that people would be doing anything related to health or medicine on an iPhone was crazy. I mean, the Fitbit was just coming out. So all of these tools are relatively new. It was still, we built a lot of that stuff. The all of Us Research Program launched. We got the grant in 2016, it launched in 2018.
So much of that was done prior to Covid, but Covid really accelerated, not only just kind of breaking down some of the barriers and the regulatory burden of being able to do things remotely, do telehealth visits, but I think it really just brought it home to people, clinical research in a way that really showcased how important it is when we have something like a global pandemic, to have participants as true partners, to really get these medications developed and out safely to the general public health. So I think there's just, there's a, like a broader Knowledge of clinical research and its importance. And there's more, I guess there's more familiarity and comfort with some of the digital tools that we use. Even, you know, today we're not in the same location. You know, I'm sitting on my computer, you're sitting on your computer. Now we have doctor's visits like this as well. Right. Or clinical research visits that are all done remotely. And I think it's just, we're all used to it now. So it really helped accelerate, you know.
[00:09:27] Speaker B: Just a little bit deep into some of your behavioral economics expertise. What, you know, where like the two or three things that you believed, you know, at the time you started working with the Scripps Institute that you really clinical research needed to do from getting to people's basic incentives. I'm curious, you know, what were some of the things, as an outside in expert, you saw were pretty obvious to you based on your work, but maybe clinical research was not doing.
[00:09:59] Speaker A: Yeah, there was, there was a lot that surprised me, I should say, when I started. And so I mentioned when I came in I did things like AB testing, right. You know, something like that. Even in general outreach for clinical research, the ability to kind of change things up and see what works and what doesn't work was new and novel. And I didn't know that because that's how it's done in other industries. So you can find out very quickly what message is resonating with your target audience, what things should you change things up? So when I got into clinical research and we realized there was a big drop off, whether it be an outreach or at some part in the consent process or in the patient journey, they were like, well, yeah, we see it's a problem, but we can't go back to the IRB and change things up. Even if it's just an email that people need to open. You already had the subject line that was approved by the irb. And to go back into that process and introduce something as simple as a subject line change was burdensome for the clinical staff. And so part of the stuff that we focused on is how do we change that upstream and identify the things that you're going to have to deal with downstream so that we can build that into our IRB submission so you have the ability to, to kind of change things.
So that's one. The other thing is, I think research in the past has been very research focused. Right? It's focused on either the researchers or the site and the participants or the patients are just expected to kind of drop everything and do stuff. Right.
To take two hours of surveys or to go down in the middle of their workday to a site to go through things. And sometimes that works. You know, a lot of times people are trying to get into these clinical trials to access care, and that's their best care option. But for observational research and just trying to get people involved, you really need to start to think like consumer companies do. Where's the value in it for the participants? Where's the incentive? And I think when we think about that, our mind obviously goes to money, right? Like, how do we start to pay participants? But that's only one way that we think about it. That's important. There are ways that you can do that, There are ways you can optimize it, but there's lots of other, you know, reasons that people do the things that they do. Right. It's fun. They're learning something. There's a sense of belonging, there's community. There's, you know, this altruistic motivation that I'm doing something that has an impact. So all sorts of things that I think sometimes gets left out if you don't have somebody thinking about it through.
Through the participant or patient lens makes sense.
[00:12:51] Speaker B: As you were talking about some of the things you brought in from the outside, what I was reflecting on and what I found ironic is obviously clinical research is the perfect A B test. It is the AB test where you're testing something against a control. And it's ironic that in the infrastructure of how sometimes clinical trials are set up, there are a lot of these cumbersome bureaucracies or barriers we erect that prevent you from AB testing. What works.
Found that amusing.
Let's get to the incentives. And I think you bring up a great point about keeping the patient's perspective in mind as you design the trial. How have you seen that? We know obviously that that impacts, I mean, clinical research underrepresents people of color today.
How do you think about better representation, recognizing that some of these barriers probably disproportionately affect people of color?
[00:14:03] Speaker A: Yeah, that's a huge issue that we deal with. And so I think you can think about diversity, equity, inclusion at every step of the process. And you really need to think about it at every step of the process because you can't just go, again, these downstream things where it's like, oh, we did this all over here, and we didn't think about diversity and inclusion up front. So what I mean by that is, even in the planning of a research program, if you're sitting around the table with people and trying to figure out how do we reach those people, right. Instead of the people, how do we reach our communities? And having the right voices, I think, from the scientific staff all the way down, including patient perspective from the beginning, but also including people who look like the people we're trying to reach. Who are the people we're trying to reach at the table from the beginning. You're going to save yourself a lot of heartache down the road. So really thinking about that, from the planning stages, from the people who are conducting the research, data privacy, security, trust. I think trust is a big issue. So that might be the way you develop your trial. It might be the community outreach that you're doing to kind of supplement and figure out where are folks, where are they already gathering, where, where do they have trust and how can we integrate in that process.
And then you talked about the barriers, right. You think about rural populations. I mean, my family is from rural New Mexico. Right. You would have to drive two hours from Santa Rosa, New Mexico, into Albuquerque Academic Medical center to even get treatment, much less go in for a clinical research trial. And so you need to think about. Also, I think if we did a little word association and talked about digital in the diversity space, we would think digital divide. But we really need to start thinking about digital as a bridge as well now that smartphone access is readily mostly accessible in most areas. So those are those considerations. How do we make it easy for people? How do we take off the burden of going into a site, getting child care, thinking about these things, how do we properly financially incentivize people for their time? Those are, those are all factors that I think we can, we could spend hours on how to best do that. And I don't think we like miraculously figured that out, but I think there are, there are things that you can think about at every stage of your research program. It really helps in that process.
[00:16:38] Speaker B: Yeah, it was a great example, right? I mean, talking about your family and if someone needs to access a clinical trial today, at least for the most chronic or critical trials, if you think about immunology, oncology, unfortunately, sometimes those trial sites are at academic medical centers. And I think one of the things we are seeing and probably a trend that's happening within the industry, is there are some pioneers who are trying to pioneer a decentralized approach where a lot of the administration happens in the patient's home that now suddenly opens up access to patients who may not have been able to travel as long as they have access to nearby imaging or Laboratory facilities. It requires a lot of coordination. And the jury is still out on whether from a. In a CRO or a sponsor perspective, the ROI is there. Right. Because ultimately some of these larger corporations also look at it from an ROI perspective. So it's interesting to see where that shakes out. Would love to learn about the work you did at Disney. I'm a big fan of Disney. I think they really nailed customer experience.
And it's one of those experiences where, you know, irrespective of your age, you leave Disney knowing that you've just visited the happiest place on earth.
You know, I'm sure you think about, like, that experience often, but, you know, how do you bring something like that? Right. And any tips on how you bring something like that to clinical research where obviously people have apprehensions, people have trust issues. Right. How do you take some of those best practices?
[00:18:31] Speaker A: Yeah. No, no. I loved my time at Disney, and I do think about it often and think about it in the context of clinical research. I always tell people, oh, it'd be my dream to kind of make clinical research magical. Like, we, we always tried to make everything magical at Disney. I don't think we're there yet, but I think there's a couple of things I think I was. I was an imagineer, which is what they call us, you know, who are not cast members.
But. But there's. There's something to be said for the way that they operate. I remember it was early in my career, and the brainstorming session they had was great. They would bring in anybody, anybody and everywhere to get different perspectives.
I think that clinical research can benefit from different perspectives. I mentioned the patient perspective and bringing the right people to the table. But I do think we don't necessarily learn enough from other industries and bring things in. So you mentioned taking things remotely and the ROI of going decentralized. I think that one of the things that I see happening is not thinking about the experience as a whole. And it's like, okay, we're going to have a digital arm or we're going to have a digital component, but 90%, 80% of what we do is still going to be that traditional structure. And then we're going to plug these in and we're going to see if it works. But that's not how you create a big magical experience. You kind of immerse yourself in it and you start from scratch. Like, if this was going to be completely remote and digital and accessible, what would we need to do differently? That means not taking your long form Consent process and just sticking it in an app. I literally, I was working on a study with some folks, and I was scrolling through the consent process and I was taking pictures because I was reviewing it. It took me 20 minutes to scroll through, and I wasn't even reading it. I was just scrolling, snap, scroll, snap a picture. And those are the things where we think that, oh, well, digital is not working, or whether it is or isn't working. We're not creating a true experience that is digital first, mobile first digital friendly, participant friendly. We're taking the old stuff and kind of moving it over. And so I think when I think about Disney and experiences and that whole holistic thing that you do, I mean, Disney thinks of everything. You have these magical experiences when you're in line.
How do we think about that in the context of clinical research? Somebody's waiting for some results or somebody hasn't heard from you.
How do we reach out to them? How do we make them part of the process? How do we. Even though our findings won't come out maybe for two, three years, how do we engage people through the process while they're waiting? Remember that they're a true partner. Remember that they're eager to see things. And that's even one thing we see. Like, oh, my goodness, return of results or return of data back to a participant. Yes, a lot of. Not all the time, but a lot of times you can do that. I think we just finished running a great metabolic health study where people were deep multimodal data, but people were able to see data as it was being adjusted by this study. And this was nutritional stuff overlaid with your continuous glucose monitor. So I eat an apple in the morning, and my oatmeal, what does my glucose response do? And they can see that right there. Like, exactly what we're seeing on the study side. And that's engaging for people. That's exciting, and it helps with adherence, engagement, whatever. Whatever buzzwords we want to call it. But it's really treating your participants as.
[00:22:18] Speaker B: Partners, as you rightly said. A lot of these experiences are maybe designed in a disjointed way. And really, I think maybe the unifying kind of approach can get more patients interested and engaged. Right? Because it's not just the patient recruitment, it's also their attention.
One last question before we wrap it up. This was really interesting. We asked this to all of the guests on our podcast, and the question is if you had a magic wand, right? So you go back to the Disney theme, right? Magic wand, and you have the opportunity to change one thing within clinical research as it relates to patients, the most important thing, what would that be?
[00:23:08] Speaker A: So right now, my big passion area is women's health. And I think we have not done enough to focus on women's health. And I'm not just talking about kind of the reproductive window, but I'm talking about women being at the forefront of research all the way from mice models all the way down through end of life care across different therapeutic areas. I think we've done women a huge disservice in clinical research. And if I could wave a magic wand and go back and make that more equitable so that we're studying the entire population rather than majority male population through, again, the life cycle, I think that's one area that I'm really passionate about right now and trying to figure out, how do we change that? How do we get more answers? How do we start to understand women's health across the lifespan?
[00:23:58] Speaker B: Fantastic. Very unique answer. And thank you for sharing that perspective. It was wonderful to have you on this podcast. Really enjoy the conversation. Thank you, Katie.
