Patient-centric Clinical Trials, from Sign-up to Treatment: IQVIA’s Tracy Mayer
Patient-centric trials are essential for the future of clinical development, but there are hurdles to overcome. The industry must adapt to the needs and preferences of patients, incorporate high-quality data, and embrace innovative technology so patients and trials can thrive together.
IQVIA is leading the healthcare industry with its unparalleled management of clinical data. SVP, Data Sciences, Safety and Medical Writing Tracy Mayer sits down with Medidata CEO Anthony Costello to explore the growth of patient-centric trials and the adoption of AI that have made this growth possible.
Join Tracy and Anthony to discover the future of data management and how it will improve data acquisition and accelerate data delivery, ultimately easing the stress of patient journeys.
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Anthony Costello 00:00
How are bold ideas born, and which ones survive to eventually shake up the status quo? We'll hear straight from our industry's greatest visionaries who are making waves and learn how they turned their dreams into disruptive reality. This is from dreamers to disruptors, a podcast powered by Medidata
Anthony Costello 00:21
When people talk about innovation in clinical trials, they usually focus on the most visible parts, like new technologies, sleek digital platforms, bold claims or headline making results. But most trials don't succeed or fail based on these things alone. They're shaped by the infrastructure behind the scenes, the systems, teams and decisions inside contract research organizations or CROs, hired by pharmaceutical and biotech firms to plan and manage clinical trials, and right now, that space is at a crossroads. CROs play a critical role in how research gets done, but the scale and complexity of these organizations and the pharmaceutical customers they serve can make change difficult, especially when it comes to emerging tech like connected devices or wearables. Today's guest, Tracy Mayer, has spent her career working to change that from the inside, she's held leadership roles in some of the largest CROs in the world, including inventive health, Syneos and now IQVIA, where she leads global teams across data sciences, safety and medical writing. Instead of waiting for change to come, Tracy has pushed to make it happen by driving smarter, more patient centred and scalable approaches to clinical trials. In today's episode, we talk about what it takes to lead transformation at this scale. We explore what covid And the Marburg virus revealed about industry speed, and we dig into why it's still so hard to design trials around what patients actually need. Welcome to From dreamers to disruptors. Hi everyone. Thanks. Thanks for joining another edition of From dreamers to disruptors. Really pleased to have Tracy Mayer here with me today. Tracy and I go way back in the industry today. She has a very big job as head Senior Vice President and head of data sciences, safety and medical writing at IQ. So Tracy, we got a lot of stuff to get into today, but thanks so much for joining. Thrilled to be here. This will be a lot of fun. Gonna get into a lot of exciting topics today, but let's start with you. Maybe you can introduce yourself a little bit and tell the audience a little about your background.
Tracy Mayer 02:22
Sure. So my name is Tracy Mayer. I head up data sciences, safety and medical writing at IQVIA. I've been at IQVIA for a little over seven years. Most of my experience is on the CRO side of the industry, so I'll happen to bring that perspective to the conversation today, and then I have a little bit of academic experience as well, which is where I started.
Anthony Costello 02:44
And we first met back in the early 2000s at SCDM. I believe we're both, we're both in SCDM. I think we were both on the board.
Tracy Mayer 02:55
I wasn't on the board yet. No, uh-uh. I was never on the board, actually. So, yeah, we met at the Leadership Forum. In Washington, DC.
Anthony Costello 03:01
That’s right.
Anthony Costello 03:03
That's right. Yep, and our paths have crossed quite a bit since then. You've been through multiple, you and Gregg Dearhammer are sort of, I watch you guys. You're my litmus test on what merger is about to happen, because, kind of, like, wherever you guys have gone, there's been some follow-on massive acquisition merger or something to consolidate the CRO industry.
Tracy Mayer 03:26
Yeah, I think we certainly both have been students, and eventually some teachers of the consolidation effort in the industry over the years. Lots of consolidation at the companies that we worked for.
Anthony Costello 3:37
Yeah, so you were at i three.
3:39
We started at Kendall. Kendall became i three. We left Kendall and went to i three, which was owned by United Health Health Group, which was kind of a unique setup. They eventually spun us off, and we merged with pharminette, and then kind of became inventive health, and then about probably 10 years ago now, they merged with Inc research, which Kendall had merged into at some point too, became CEOs health, and I was at Syneos Health until about seven and a half years ago, when I left and joined IQVIA.
Anthony Costello 04:13
And you’re doing fantastic things at IQVIA, we work a lot, Medidata and IQVIA work together a lot. I think we were talking about earlier. I think collectively, our companies have done like 2500 clinical trials together.
Tracy Mayer 04:26
At least. We've done a lot together.
Anthony Costello 04:29
It's a lot. And I think you know what I wanted to kind of pivot into, given your vast experience and all the things you've seen you, and I joke all the time that you you, you know where all the bodies are buried in this industry for the last 20 years, but you've, you're a self-described, maybe reluctant disruptor.
Tracy Mayer 04:46
I think that's fair.
Anthony Costello 04:47
You didn't, you didn't jump into the industry to, like, shake everything up, but you've actually turned out to be a big mover and shaker over the years and through a lot of these different roles that we just touched on. So can you talk a little bit about, sort of, what do you mean? What does it mean to be a reluctant disrupter, and how have you stumbled into adopting that role?
Tracy Mayer 05:07
Well, I think a lot of people get into clinical research, like reluctantly or accidentally, which is the same story for me too. Like I was in college, you know, I needed a job. The hospital in Cincinnati was hiring. I got a job. There's like an internship as a patient care assistant for a summer. Did that for three months, and at the end of it, it was, it was over, and I liked working in the hospital, but I didn't really know what I wanted to do next. Then was talking to some physicians about it, and they said, Hey, why don't you stay on and be a research associate for a while? And I was like, Well, you know, what does that entail? And they're like, you just enrol patients in clinical trials. So pretty straightforward. It paid double minimum wage at the time, it had hours that worked great for college, right? You just had to carry a beeper. Yes, the beeper. And you've worked nights and weekends, and if you worked on holidays, you got like a differential. So, I mean, it all stacked up well for me, like, this is a pretty good paying job in college, so I signed up for that, and I just kind of fell into it. And, you know, back then, it was in the emergency department at UC at the University of Cincinnati, go bear cats, and the trauma room was obviously a really busy place, and a lot of the research we did was investigator led, but they were starting to do clinical trials with some pharma companies. And it's a little bit unique. In the emergency department, the patients are only there for a period of time, and then they move up to the floor. So they're kind of short clinical trials. You know, most of them, you enrol a patient, they might be in it for 24 hours, and they move on. You might do follow up or something like that. So my entire job, though, was going and talking to patients and, you know, convincing them to sign up for a clinical trial, most of them around stroke and cardiovascular issues. We did some traumatic brain injury, some orthopaedic stuff, but in most cases, for most of these people, was like the most stressful day of their life or the hardest day of their life. And you're asking them, you're walking into the room and saying, “Hey, do you mind signing up for something you know that probably won't benefit you at all today, but my-”
Anthony Costello 07:08
Investigational, not approved by anyone, like, “Try this thing.”
Tracy Mayer 07:12
Yeah, it was all little like, on the fringe, right, all on paper, you know, file folders everywhere, and some random student asking you to sign up for it, and all of them are willing to do it, you know. And so it was like, some really cool conversations came out of that. And then a lot of times these patients would go upstairs, and we continue enrolling people in these studies, and you'd have to go upstairs to get, like, the 24 hour blood draw, and you might see the family again and talk to them again, and you'd find out how they were doing, and you'd enrol another patient that ended up on that floor, so a couple days later they might still be there, and you'd check in on with them. So that patient piece of it started to come into play for me, where I was like, “Wow, this is kind of a cool job. Like, it's not just about just about getting people to sign up for something, you're getting somebody to sign up for something, and, like I said, the worst day of their life, and they're willing to do it selflessly, because they want to be part of the experiment and part of, you know, doing something better for somebody else in the future.”
Anthony Costello 08:02
Yeah, and I think, you know, one of the things that I love about people like you that have been in the industry for a long time and been in a lot of different jobs. I think it gives really interesting perspective to the job you do today that you've been in different types of service organizations, very different size organizations. You've been a CRA you've been a data manager, you've been involved we're going to talk about sensors. I know you've been really one of the people in the industry spearheading the use of wearable devices and decentralization and patient centricity and all these things. And it sounds like some of that goes back to this very first job, right? That close proximity to the patient is something most people in our industry never actually get, unless they're a site, obviously, or CRA a lot of and even some CRAs don't have the close proximity to the patient, they have the proximity to the patient's chart right and to the review, and maybe even that's done remotely more and more. So, you know, it's an interesting dilemma in our industry that we want to be closer to patients, but so few people participating in the conduct of a trial, really, having the occasion to be close to a patient.
Tracy Mayer 09:11
That's a job I think probably most people in our industry should do at some point in their life. You know, go be a site coordinator, or, you know, go do the day in the life a few times at sites and, you know, get to know what it's really like to experience that, and specifically to consent a patient. Because I think. A humbling experience, especially you know, circumstances like patient oncology trials, patients that have cancer. You know, in the case of the emergency room, people that you know had strokes, and in some cases, were unconscious, and their family had to give consent for that, and they really didn't know what the outcome was going to be. But again, you know, at the end of the day, they were willing to sign up for it and be part of the experiment, because they didn't want somebody else to go through that. That's a pretty humbling experience.
Anthony Costello 09:51
Maybe this is a good chance to pivot into the CRO industry today, because I think it all sort of ties together, right? The the CRO industry is, let's just face the facts. It's under pressure, right? And a lot of industries are AI is shaking up services in almost every industry you can think of, and there's more and more opportunity for these models to do the types of things that we have traditionally thought of as workflows that were done by people for, you know, all the rest of time and and so, you know, I'm really curious to hear you're, you're a big senior leader in the biggest CRO I mean, IQVIA is bigger than most pharma companies. I mean, it's bigger than most big pharma companies combined, and has a lot of influence, does a lot of studies, sees sort of the good, bad and the ugly of everything that's happening in the industry. And so it would seem that an organization like IQVIA would sort of have to have the best strategy around how do we use AI? How's AI going to change us? And how do we stay on the leading edge of that? I don't know if that's the case, but I'm curious to hear from you, kind of, what does a modern day CRO look like, and is that industry? Is that part of the industry evolving ahead of the curve? Behind the curve? Are you trying to push customers, or are they pushing you? Like I'm really interested to hear your take on that.
Tracy Mayer 11:29
Yeah, I think. So, my feeling about IQVIA is we are ahead of the curve. I think one of the things we hear a lot from customers is that we're very honest about where we are on our journey. So I think there's often the expectation when you work at a place like IQVIA that you're going to be even further ahead of the curve than you really are. But I feel like we've taken a really honest approach to talking about our journey with AI and, you know, at a company is because IQVIA, there's multiple layers to the strategy, right? You know, you've got big corporate layers, big corporate strategy that, you know, we're all trying to work with and utilise wherever we can, but we also look at it more at a functional level, or a BU level, or departmental level. I run a BU so, you know, my responsibility, my team pretty much focuses on how we can leverage it in use cases that make a difference with data flow, the data aspects of the study and the functions and services that I work with. So I think one of the hard things about AI is you really have to figure out a way to compartmentalize it a little bit to get something accomplished. And I think that's what we've run into at Hugh V in general, with innovation, I have a dedicated innovation team that works for me, but where we've been successful is trying to figure out ways to apply that on a scale that you can actually move something forward with if you try and apply it to everything we do at IQVIA with all the customers we work with. Because we work with so many different models and so many different types of customers, it just, it would never, it would never work, right? So, you know, our AI journey is really about trying to figure out how to apply the use case or the strategy at the right level that makes the most sense to actually be able to move something forward and get momentum.
Anthony Costello 13:11
Yeah, and when you find one of those use cases that can move the needle, I'm assuming you can, you take that concept to a customer with a rationale behind it, like we've discovered that we can reliably, at scale, do this thing in a different way. And then are they, do you find reticence on their part to adopt it? Or are they actually saying, “Hey, can you move more stuff faster with AI, because we want to accelerate the overall development program using that as a tool?”
Tracy Mayer 13:39
Yeah, I think it's all about the approach. Like, you know, I think nobody really wants to be told what to do, right, myself included, so you have to keep that in mind, but it's really the approach, what we've been trying to do with customers, because there's always this dynamic between pharma and CRO, where they come to CRO, and some people feel like the pharma needs to tell us what to do, whereas I feel like it's our job to, you know, offer ideas around a strategy for them, offer them options. You know, it's kind of the beauty of working with the CRO is we work kind of with everybody, so we see a lot of everything, trying to figure out, you know, how we can take use cases that we've applied internally, using our tech, our platforms, our instance of rave, for example. Possible, and then going to a customer and saying, Well, you know, your instance is different. You use different standards, but let's still talk about what is possible if we collaborate and kind of, you know, use the best of both, like what we've done somewhere else might still work, even if we have to use your systems and tools. When we first started on the journey, the innovation journey to QV, when I got hired seven years ago, we kind of went all in on like, this is our path, right? This is, this is the way we do it. Like IQVIA has kind of got a reputation for saying, this is the IQVIA way, right? And we ran into customers, especially in an FSP model, where they were like, we're not interested in doing it your way. We actually need to use our systems and our tools, you know, because they've made investments and platform and people in process, and so you just kind of got this, like, butting of heads, and again, you're not really doing anything meaningfully different to change the outcome for the for the customer, they weren't making progress. So the last like, two or three years, I've really challenged my team on put, like, our process, their process, aside for a minute and just work on the solution, you know, looking at it from the perspective of what's possible, like, what is possible if you put that aside, you know, conceptually, what are we trying to get to? And then you can try and figure out what the customer, which tools you bring in, which process makes sense, etc, yeah.
Anthony Costello 15:39
And if you, I mean, I can speak for Medidata, if we find an AI-driven process that shows some undeniable benefit, customers are usually excited about that.
Tracy Mayer 15:50
Yep, absolutely.
Anthony Costello 15:52
But it is a little bit of a challenge, right? There's this, there's this sort of experts dilemma challenge, where it's like, if the AI is giving me the same answer that I already know, then I don't see the value of AI if it's given me a different answer than what I thought, then I mistrust it, and I have to sort of get stuck in cycles of validating it, making sure that it's believable. And I think these things kind of make the adoption curve challenging, especially in an industry like ours that's already a little bit reticent to jump into brand-new technologies, especially black box ones like AI, where stuff is happening that you can't completely see and understand.
Tracy Mayer 16:31
It's interesting. Even if you talk to customers right now, you could talk to two executives from the same company, and you know, one will tell you they're really far ahead on the roadmap for AI. And you talk to somebody, you know, an hour later, and they're like, “We haven't done anything yet.” You know what I mean? So I think people are even struggling to figure out, you know, what having a strategy means. Like, having a strategy isn't enough, right? It's like, how are you really going to execute it? How you really going to make that happen for people? I think that that's that seems to be a really big disconnect in terms of people understanding that it's not just about having the idea you've got to have a path to execute it as well.
Anthony Costello 17:07
Yeah, yeah. And our industry is sort of famous for having a bigger aspiration. Like we, we sort of know where we should be, and then we have difficulty sometimes, yeah, getting there so well.
Tracy Mayer 17:19
And I feel like so much of what we do and have done over the last 25 years, I've been doing this, or they're like these people talk about it being like a five year aspiration. It takes 10 years at least, right? Think about like, when we went from paper to EDC, and, I mean, it took forever, right? I think we just finally, like, decommissioned our last paper studies two years ago. Yeah. I mean, they were super long term studies, but still, like, what are we doing, right? And, you know, people talk about, you know, something like that as being like a five year aspiration. I'm like, you know, 10 years ago we had five years to have an aspiration, you know, and maybe even five years to have a 10 year reality. But nowadays it's like, look what happened two years ago, with, with, you know, two, two to three, four, even five years ago with covid. Now, it's like that was a great example of where you didn't have five years to come up with a solution to achieve the aspirations we all had, to solve a problem really quickly.
Anthony Costello 18:14
And but this is the kind of case in point, right? It's like we know that we can do these things faster. And I know everyone talks about covid is the use case of, we jumped the hype curve, and we made it all happen, and it worked, and it was a 12 month blah, blah, blah, but, but then we sort of slipped back into this mode of, let's go slowly, let's be selective. Like, and I feel like, I mean, I'm curious to know your thought, but I my sense is that the AI adoption curve is happening much faster than almost anything else I can think of in our industry over my entire career, except for the one covid moment where there was a global pandemic and no option but for to accelerate the adoption, Yep, yeah. Do you see that AI curve happening that much faster? I mean, do you think it's going to come in two, three years, in some big way? And not like we think it'll be five, but it actually turns into 10?
Tracy Mayer 19:12
On some level I think it has to, just because what's going on, you know, with the macroeconomic environment right now, unless something significantly changes there, which I don't think that's the reality. But, you know, I think the challenge that we have is you really have to figure out ways. And again, I think IQVIA is a good lesson for this, or having a job like I have at IQVIA is a good lesson for this, like you have to figure out ways to drive adoption and large organizations to actually make that happen. And it's hard, right? People don't, people don't want to give up their spreadsheets, right? We didn't want to give up paper. CRFs, so it's hard to criticise. But, you know, this is where I think a big part of my job, it's, you know, I do, you know, I really take the the opportunity to lead innovation, innovation in at a company that you know has influence in the industry as a serious part of my job, but I also have this other part of my job, which is leading operational delivery, right? And that part of my job, I think it aligns well to the personality of a data person in that it's really about you've got to set measurable targets and really force people to achieve them, and hold people accountable to that. There's some good old fashioned aspects of just holding people accountable that are necessary to make this happen. And I think anybody that's a leader in our industry really has told people through that.
Anthony Costello 20:31
Yeah, absolutely. But I think this is one of the things that I think is so great about your personality and you but also the way IQVIA has set this up organizationally is we find lots of different organizations where we have one person who's leading innovation, and that can be as exciting and disruptive and interesting and forward-looking as you want, but then it hits another operational organization that's supposed to scale it, standardize it, rewrite the SOPs, get everybody to some sort of like learning curve, steady state, and think a lot of innovation, I won't say, dies at that phase, but hits the harsh reality of the study team that has to adopt it and use it and take the new risk on their trial, or come up with a budget to fund the new idea on their trial, and it slows the curve. It slows the curve. So wrapping those things up into a single person or a single role that's seeing both sides of the coin to make these things happen, you know, it makes sense that it would help you accelerate the overall process by doing that.
Tracy Mayer 21:36
I have a dedicated innovation team that works for me, that reports into one person, you know, she's got, you know, 20 people that essentially do nothing but focus on coming up with the ideas and executing them, and running the pilots or the use cases, and then turning it over to the operational team then to make it reality for us from that point forward. That's a key part of making change happen, too. You have to be willing to invest in those types of resources and find people that are really good at that, like, you know, I have Sabrina Steffen running my innovation organization, and, you know, she's really good at balancing the aspirational with the operational too, and that's just a reality we all face in the industry. You have to be able to do both really well to make it happen.
Anthony Costello 22:17
Yeah, yeah. So we covered AI a little bit, but other innovations that I think of when I think of Tracy Mayer are, you've done a lot to pioneer the use of wearable sensors in our industry. And we talked about your background-
Tracy Mayer 22:29
Not enough, apparently.
Anthony Costello 22:31
Well, that's kind of what I want to get into. Yeah. So, you know, I think if you, if you just surveyed 100 of our customers in pharma, biotech, medical device, I think they would all say we're interested in patient centricity. That's a focus. We're interested in standardizing the types of technologies that sites can use so it's easier on sites. That's a focus. We're interested in continuous monitoring and decentralization and reaching out to patients in their real lives to study them in the same conditions that the drug will be in a commercial setting. All of these things are sort of on the tick list of priorities. But when you actually try to run a study that has lots of decentralization, or the use of wearable sensors-
Tracy Mayer 23:16
Rolling it all back.
Anthony Costello 23:17
Big components of patient centricity. And you know, if we're not in covid, and you try to do some of these things, it's still very, very challenging, even for someone who runs thousands of trials for the entire industry with an 11,000-person organization that can really focus on all these areas. So you know, what the hell like? What do we need to do? Can you be patient-centric? Let's just start here. Can you be patient truly patient centric, if you're not doing some of these things to lower the burden and change the way patients interact with the science, with with the research between site visits,
Tracy Mayer 24:00
Yeah. I mean, it's such an opportunity. I think the thing that frustrates me is we're talking about things like, you know, EMR to EDC being this, like, futuristic thing, and we need it, right? But it's like, again, this has been an aspiration for how many years now we have things, you know, including, you know, Medidata, has Health Record Connect that offer us that advantage now it bridges the gap that we have. But why aren't we talking about getting the data directly from the patient? Why are we relying on something like a medical record that is, you know, so fraught with data errors and issues, and you know, it's notoriously poor data from the get go as the single source of data from patient when we have other better options that get us cleaner data and get us get us the data immediately, and we can make those decisions. And you people want to talk about visualisations and insights and analytics and all of these things, you know, but they want to do it on data that's like, you know, three months old, and you're like, what are we doing, right? So, yeah, there's a huge opportunity in connected devices. And I think even more so when we start to talk about, you know, studies for things like obesity, where, you know, those obesity drugs really make a difference in terms of quality of life for people. And you know, sensors do a great job taking data from patients all the time. They can truly measure how effective that that drug is for you over a period of time. It's not just the day you came into the clinic. How do you feel? How do you feel today? It's a measurable, quantified way of saying, hey, this patient moved more today. They moved more for six weeks because they lost weight. So there's just a lot of opportunity, you know, beyond basic vitals collection and things like that, that sensors and wearables provides us in clinical trials, and we're just not taking advantage of it enough, yeah, and I also think part of that too, is the people that make the decisions about this. It's a very fragmented thing right now, like I have connected devices sitting, you know, in my business unit reports into me. We think it makes a lot of sense to put it there, because it's a source of data, right? And we're looking at the entire data picture. That's how we're trying to tackle data science. But the decision makers for connected devices are all over the place. It's really easy to find who decides, you know, for clinical or who decides for data management, but figuring out who would a sponsor makes a decision around connected devices has been a real challenge.
Anthony Costello 26:14
Sure, well, and there's always a lot more people who can say no to it, then, then, the champion that really
Tracy Mayer 26:22
takes the risk.
Anthony Costello 26:24
yeah. And there's also, I mean, let's just be let's just be honest. I think one of the concerns about continuous data is that it shows you a lot of stuff that you might not be looking for. It might give you a signal that you or don't want to see, or that's not even in your protocol. What do you do when the continuous data tells you that you're causing a sleep problem? I'm making this up, but causing a sleep problem that you weren't even trying to measure for on the study, and now it's a side effect of your therapy that you have to grapple with.
Tracy Mayer 26:55
Yeah, but I mean, I think the the other side of that coin, you know, being a little provocative, is, you know, there's, there's some distrust of what we do out there in the world today, where people feel like we make those decisions to hide data points and things like that. And the truth is, we don't do that. So why would we have a problem with being transparent about the data that gets collected from a patient and dealing with the reality of what's presented to us? And often, it might present a point that we don't like, but I think probably more often than not, we're going to get data that shows us something that's a positive. So it's a balance. But again, I think you also need to think about the trust perspective on that
Anthony Costello 27:29
Absolutely. Oh, and the fact I thought where you were going to go is like, you're going to find out there's a problem with this in the post market.
Tracy Mayer 27:34
That's true too. That’s true too.
Anthony Costello 27:35
So you know, if there's a problem, there's a problem, and find out the problem sooner. What's the point of the clinical research in the first place if you're not unearthing as many of the challenges or issues or drawbacks as well as the positive benefits at the same time?
Tracy Mayer 27:50
Again, it's like, if we're all going to stand behind the job that we have in the role that we play in this we shouldn't really have a problem with transparency in the data.
Anthony Costello 27:56
Yeah, totally agree. So you know, what do we do now? What does Tracy Mayer do now at IQVIA with, I don't know, 10,000 different customers that all have a different set of preferences. So I want to just set up this scenario a little bit. We come out of covid where everything was fair game. We were all patient centric. You got to do all the cool stuff with technology that in your heart and soul you really want to do. But now we've taken a step backward. We've layered in a bunch of AI that ushers in this whole new era of, do we trust it? Do we validate it? How do we use it? How do we bake it in the tools? I mean, what AI can we put in front of a patient is very different than what AI can we put in front of a site, right? The all these challenges and 1000 masters to serve that all have different preferences for your business. You know? How do you make a recommendation out of all of that for what we should all be focused on over the next few years? Like, what's your call to action? Or what would you love to see if EHR to EDC is too small a swing to take for the next five years, and I agree, like we're there now. I. Why can't we to have full adoption of that in the next two years? But then what? What does 456, years out from today look like in Tracy's world, where we really change the industry?
Tracy Mayer 29:15
Yeah, I feel like we've lost line of sight on the goal of really being patient centric in the way that we, you know, get people enrolled in trials, the way that we tackle the problems that we're trying to tackle. So for me, you know, the call to action, or the five year goal, is getting back to true patient centric clinical trials, where the patient's at the heart of it are focusing on, you know, getting a patient enrolled so we can get, you know, the data asset that we need to be able to provide, the outcome, the approval or the decision that we need to make to bring the trials, the trial to market and everything else. I mean, AI, it might help us get there faster. Connected devices certainly will help us get get there faster. But at the end of the day, this, to me, it's like we we need to kind of compartmentalize that aspect of it a little bit and start making decisions based on that as the goal. I think we've lost sight of the goal a little bit in doing all of these other things. AI in particular, is, is it's a big aspirational thing. It's really exciting people, generally speaking, people like, like to talk about what's possible there. But you know, our industry isn't, doesn't exist to create AI, or do do AI, our industry exists to bring medicines to patients faster. So let's get back to that thread and figure out how to use these other things that we're talking about to actually make that happen.
Anthony Costello 30:34
That's right, yeah, I think we talk about it at Medidata a lot, and it's, it's sometimes it's easy, sad to say, but it's easy to lose sight of that speed component. I think when we, when our industry, thinks about patient centricity, we think about, how do we deliver technology to the patient in a better way? How do we simplify the consent process for them? How do we find, how do we enrol in a diverse way? How do we, you know, allow for bring your own device, like these types of somewhat tactical things that move the needle a little bit, but the ultimate patient Centricity has to be, how do we get the drug in prescribers hands faster and through that process, much faster solution? And that turns out to be sort of the sum of all of these little incremental things that we can do. And the trick is, how do you pick the right framework of incremental technology and process improvement, yep, so that you kind of warp speed the 10 year long development process into something that looks a lot more like what we did, yeah, during covid, yeah.
Tracy Mayer 31:34
I think the reality is you have to do a little bit of all of it too, right, to really get there. So I think the industry is pretty good at doing, you know, the whole continuous improvement, thing, you know, I don't think there's a single RFP that we respond to nowadays. It doesn't have a question and ask for an entire section on the types of continuous improvements we do. And we can jot tonnes of them down. But at the end of the day, they, you know, they they change just a little bit of something in a specific clinical trial, and maybe provided the seeds for something bigger. But for the most part, they they were just that incremental changes. I think what everybody needs to push themselves to do again is go back to like, what's really possible if you step outside of your current framework, stop thinking about my job is to come up with, like, the aspirational side of it, my job, and then we let the some of the solutions fill in, fill in for that, right? Like, my job isn't go out and pick the next platform for us, you know, to achieve whatever if the end and goal is, it's to say what, what are we trying to do here? We're literally trying to deliver clinical trials as fast as we did during covid in startup. We're trying to do it in two weeks. You know, right now they're 20 weeks. I feel like we've been at 20 weeks for 10 years, right? So we're saying, all right, we want to do this in two weeks. We're in the case of, you know, the one Marburg vaccine study we did together, we did that in a week, right? And everybody had to make decisions or take steps to make that happen. You guys flex. A lot of it was processed too. Like you guys flexed on your process and requirements for signing a contract and setting up a URL, and then we had to do a bunch of like, it was programming flex on our side, the customer flexed and that they were willing to just go all in on our standards. Like, we're not gonna change things on the case report form because we like this, or we like that, we're fine. We'll just go with exactly what you guys say is, you know, the data points that need to be used for the study, and we'll go all in on it, and we got it done in a week. And if you take a step back and think about what that all was, it's like, are we really telling people that you know our requirement for signing a contract or standing up a URL, or following a certain case report form, or changing something on a CRF, is really allowing us to go from one week to 20 weeks. That's what we're doing all the time, all the time, letting decisions like that make a study take, you know, four months longer, five months longer because we can't figure. Out a better way to sign a contract or figure out a better way to, you know, get people to agree to standards on a case report form. Yeah, it's really hard to, if you go from the patient centric perspective, it's hard to explain that.
Anthony Costello 34:09
I’m glad you brought up this example, because I It slipped my mind that we had this actually one week example or two week example. But a lot of what you just described, for all of us that were involved in that use case was cutting out the white space between the actual activity that you do, right? So programming the CRF is not that hard. AI Medidata is rolling out AI functionality to build the CRFs automatically now, based on the protocol. So it's going to happen in, you know, five seconds. But the challenge is negotiating the requirements documentary and waiting through getting people to agree on the field you're collecting, the fields you're collecting, and what are you going to do with them, and where's the stat plan, and where's the data management plan, and, oh, the person with the last sign off is out for two weeks, and, like these sorts of things are where the two weeks of actual elapsed time work like turns into calendar time work that takes months and months. And, you know, you know, we have a big patient program at Medidata. And when we run these workshops with the patients that work for us, almost always, they start with, when you're, you know, arguing over the wording with the IRB on the one sentence in the consent form that's holding up this trial. You know, remember two things, like, I'm losing time, like, literally losing time that I have to survive because this trial hasn't started yet, and I'm probably not going to care that much about that sentence. The spirit of what I'm signing up for is still the same. My doctor is still going to describe it to me the same. I'm still going to go to the back page and sign up for it because I'm desperate. All the same, right? And same goes for the CRFs. And, you know, the the the analysis plan, like there's especially if we start capturing continuous data and finding new data sources. We're all getting better at being ecosystem players, to pull in more complex data, sort it out faster, get the AI to help us with anomaly detection and whatnot. These things can provide massive acceleration if we don't kill all that opportunity with a whole bunch of old style process in the middle where all the time gets lost.
Tracy Mayer 36:20
Yeah, and I feel it makes a meaningful difference. There's, I feel like more and more, a lot of the studies that we're doing, we've been doing more with biotech and small to small, mid pharma, whereas IKEA used to focus kind of on bigger Pharma. We, I mean, we do all of it, but it's been a little bit of a shift in the industry, and so we've shifted with it. But in doing that, we're running into these biotech companies that, one, you know, can only survive and thrive if we do things fast enough for them. And two, these are the ones that generally work on the drugs that don't get any other attention right, because it's either, you know, a disease that there's just not that many people that have it, or it's just not for not funded that well, or whatever it may be. But one example that really kind of brought this home for me. Recently, a neighbour of mine was diagnosed with pancreatic cancer, which has been around forever. And I know other people that have passed away from it. It's horrible disease, and generally speaking, really bad outcomes. And he the the husband was talking to me about, you know, clinical trials.gov and looking for trials to sign his wife up for, and they got her in a couple things, and at the end of the day, the outcome wasn't good. But shortly after, she was about a month or so into treatment, and they came out with a clinical trial that actually has had some pretty promising results in terms of quality of life and just extending the amount of time people have, and she missed it by two weeks. And it's just a reality check, like, if they could have gotten that trial up and running two weeks faster. You know, this person that you know could have had a better outcome, or at least you know, more time and better quality of life. And for me that, you know, 25 years ago, when I was just enrolling patients at UC I don't know that I would have understood that so much, but I feel like now, yes, the cool part about my job, I actually can really, you know, use that information and press that upon my team. Like, two weeks really makes a difference. You know what I mean? I mean four months really makes a difference. So, you know, people get lost in making case report form change or asking another person to come into the review group. It's like, this is what happens when we take two more weeks, guys, what are we doing? Right?
Anthony Costello 38:26
Yep, I we hear that all the time, and I love how you brought that full circle back to back to your beginnings in the industry. So I think, you know, let's, let's end it there. I think that's a good, good place to cut this off. Patient Centricity has got to continue to be a focus in our industry. But we shouldn't think about it so much as simplifying this tech or that tech. Those things matter. Those things are very important, obviously, to our industry and to patients. So. But if we keep the focus on, you know, the two weeks that we take screwing around with something that really doesn't make that much difference, is two weeks that somebody doesn't have a difference and getting that drug through the whole process. Like, let's try to look at AI as the clinical development accelerator, not the scary new way that you're building. CRFs, right? Because we've got to have the bigger picture there if we're really going to get the industry to come embrace it as fast as as I think we both know we should. Yeah, I agree. All right. Tracy Mayer, thanks so much for being here. It's great to talk to you, and we'll do it again sometime. Let's see. Let's see what another year in our industry brings, and maybe you can come back. Sounds great. That'd be fun. Thanks.
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