The Challenges of Clinical Trial Digitization and The Digital Medicine Society (DiMe) Mission: Jennifer Goldsack
Jennifer Goldsack has made it her mission to push the boundaries of how technology can enhance healthcare. As founder and CEO of the Digital Medicine Society (DiMe), she supports digital innovators exploring new ways to deliver better outcomes for patients everywhere.
Jennifer and Medidata CEO Anthony Costello explore how clinical trials once led the way in life sciences digitization, why they’re falling behind, and how we can get our industry back on track.
Join them to discover how Jennifer is promoting innovation and making smarter use of clinical data, as well as her personal story of navigating the healthcare system and confronting the everyday challenges patients face.
Follow Medidata: LinkedIn, Instagram, X, YouTube
Follow Anthony: LinkedIn
Follow Jennifer: LinkedIn
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 turn their dreams into disruptive reality. This is from dreamers to disruptors, a podcast powered by Medidata. Ask anyone about the future of clinical trials, and you'll hear about AI, digital biomarkers and decentralized research. But technology alone doesn't change an industry without a willingness to do things differently. Too often, progress has stalled. Trial matching, once considered pioneering, is still being pitched as a breakthrough 15 years later. Meanwhile, the cost of drug development remains unsustainable. A decade to bring a new therapy forward with only a 5% chance of success and at a cost of $150 million if we don't find better ways, the backup plan will likely continue to be longer, trials, more starts and stops, more amendments, more burden and cost for everyone, and fewer new therapies for patients. That's where today's guest comes in. Jennifer Goldsack is the founder and CEO of the digital medicine society known as DiMe, an organization built to be a catalyst. Dime connects pharma technology and patients helping leaders turn ideas into real change. Jennifer has spent her career challenging the status quo and pushing for a future where innovation drives how we develop medicine that improve patient lives in today's episode, we'll talk about Jennifer's journey as a disruptor, why willingness is the missing ingredient for adoption and how new incentive structures could unlock faster, better research. Most importantly, we'll look ahead to her vision for healthcare and what it will take to get there. Hi everyone and welcome to from dreamers to disruptors. I'm very thrilled and honoured today to have Jennifer Goldsack as my guest. As you know, Jennifer is founder and CEO of the digital medicine society, and Jennifer, there's, there's so many topics that we have to get into today. I can't wait. I know I've been really looking forward to this edition of the podcast. So thanks again for being here with us today.
Jennifer Goldsack 02:23 Delighted to be here, Anthony. It's always a pleasure to talk to you, and we quite often end up exchanging some strong opinions. So looking forward to our discussion today,
Anthony Costello 02:32 This podcast is all about strong opinions. So feel free to feel free to lay those on thick and you know, but before we jump too much into that, because I know we've got 10 different directions we want to go in this conversation, I want to just start with you, your your story, maybe a little bit of the story behind DiMe. It's an organization that's done so many things that honestly have just never been done before in our industry, and that's hard to do, and to your credit, you've been able to really forge that path for the organization. But it's also central to what this podcast is all about, right? Like we're all about the dream that somehow has a champion like you that can piece it all together and make it a reality. So, you know, give us a little bit of that background about yourself. And DiMe.
Jennifer Goldsack 03:29 It's a great name for a podcast, and it really resonated with me, starting with this notion of sort of being a dreamer, or sort of having this very clear dream. This is actually my second career. So my first career, I actually was lucky enough to compete at the Olympic Games in 2008 out in Beijing. And despite the accent Anthony, I actually competed for the US team. My mom's American. I moved to the US the winter, 2007 2008 when you have the opportunity to be on the US Olympic team, you run after that with everything you've got. And you know, there's a real challenge for folks as they retire from being elite athletes, is you think about the fact that for years, you wake up with a very singular goal. Today, I want to be the best in the world of my sport. And you give yourself permission to be quite selfish in that pursuit. You give yourself permission to be doggedly focused and to sacrifice everything in pursuit of that. And then you get to the end, and you know you've been at the pinnacle of your sport, your field, your career, and then as someone in your mid 20s, you have to start afresh. And I had to do that in the fall of 2008 and if anyone remembers the market conditions in the fall of 2008 it wasn't a great time to be running around looking for a job. I'd always thought I had more education than I knew what to do with because clearly a team player, I'd gone to the Olympics. I'll be fine. I'll get a job. And then I was living in Philadelphia at the time, and the only place that was hiring was the hospital at the University of Pennsylvania. And my background, I'm a chemist, of all things, so you don't meet that many inorganic chemists, but my research was into liquid crystals. So Anthony, I don't know whether to say to you and everyone listening in, you're welcome, or I'm sorry, because we all spend far too much time looking at screens these days, but that was my work, and ended up really getting picked up by brilliant researchers at Penn. They figured that I knew science and I knew how to do research, and they could repurpose me to do this in healthcare. And the reason I give it this long wind up is a couple of reasons. One, I grew up with a very, very different healthcare system, and I was always curious about how the healthcare system in the US worked, and frankly, wanted to make it more accessible to the majority, because I knew that that wasn't how our system was incentivized or structured. So I had the opportunity to do that, and very quickly, I became as passionate about showing up to work every day to try and improve the industry that exists to care for people as I ever did in my very own selfish pursuit of, you know, chasing world records and medals and the Olympic Games. And I really, personally, have found this fulfilling, and it was never hard for me to pivot in my career because of the work that everyone in our field does every day and how vocational it feels. The second piece of that is the timing I had was really on the forefront of digitization of the industry. So you think about 2009 the High Tech Act was passed. So I was there. I was doing health services research as we started to introduce, you know, the 1.0 of the electronic health record. So eMAR CPOE, I was in healthcare delivery for a good chunk of time. I then had the privilege to pivot to the clinical trial side of the house, went through a few startups, and through all of this, was absolutely convinced that digital is, I believe, the only way that we can drive towards a sustainable health system. We have to get this right in order to make sure that we can keep developing medical products and keep caring for people in a sustainable way into the future. And that was the impetus for founding DiMe in 2019.
Anthony Costello 07:22 So from the Olympics to making our computer screens to founding DiMe. And you know, I know a lot of what we want to get into today is, of course, I agree with everything that you're saying, right? Digital is one of the big keys to transforming the way our industry works, and probably every guest that we've had on the podcast to date has had some angle on that. But a lot of what we thought would be transformational. You're talking about some writing on the wall back in 2008 2009 and I know many of those things, we still struggle to find the right adoption methodology for many of those technologies, even today, right? I mean, one of the things that we want to talk about in the podcast today are some of the things that got a little bit of traction way back then that are still being discussed today as new innovation, quote, unquote, new innovation, and that we still are challenged as an industry to adopt in a way that can make a big difference. But I really want to frame up a little bit, what is the core mission of DiMe and kind of how? How do you see DiMe today, operating in the context of a pretty complex industry with a lot of different players, a lot of different initiatives, a lot of different technologies. How does DiMe fit? And really, when you decided to start DiMe like, what was the thing that you really wanted to attack and solve for?
Jennifer Goldsack 09:02 It's such a good question. And you know, recently, I've been reflecting on, where were we in 2019 and where, where where are we today? And in 2019 we established DiMe to say we believe that there is a small but mighty cadre of innovators across medical product development and healthcare delivery who are really thinking differently about the new digital tools in the toolbox and how they can be deployed to fundamentally reimagine the way that we develop those new medical products and the way that we care for people, and we set ourselves up as a nonprofit, not one that provides healthcare, conducts clinical trials or develops our own medical products, but as an entity that's dedicated to supporting those individuals. Jewels and those organizations that do in order to improve the lives of patients. And it's really interesting to think about. When we started Anthony, we were absolutely committed to bringing together all of the different stakeholders across the ecosystem, from providers to systems to payers, to government agencies to policy makers, to life sciences companies developing new products, to public health institutions, to investors, to patient groups themselves, and we wanted to look across healthcare delivery and medical product development, because one of the things that I think defines digital is the fact that data doesn't live in a manila folder locked in a file cabinet with just the PI or the practice manager having the key. The fundamental fiat currency in the digital era is data, and we want to stop kids who are in a clinical trial having to take a day off school on a Tuesday to go to one side of the campus for their study visit, and then have to take another day off on Thursday to go and visit their healthcare provider on the other side of the same campus. That is not how we should be practicing healthcare, and that's not how we should be developing medical products. So we had this quite bold vision back in 2019 and the thing that I would say is fundamentally changed, which I think is a positive. You know, you and I are impatient. We see the possibilities. We want to see things moving faster. But what's really interesting, if we benchmark 2019 vis a vis today, in in 2025 is, I actually think our fundamental mission at DiMe has evolved. It's not about helping this small but mighty cadre of leaders who are thinking differently. It's actually about healthcare and the digital era. This is not an edge case anymore. We can see what our colleagues in the federal government, astp, o, NC, CMS, FDA, they are being very clear about their ambition around digital we can think about the proliferation of virtual care, decentralized trials, the use of a variety of different tools in both health and wellness and in healthcare delivery, oddly less so than I thought we would be when it comes to clinical trials. But we can get to that. But really, this is about healthcare in the digital era, as we sit here in 2025 it's not a small faction of the industry who are doing interesting things on the side.
Anthony Costello 12:23 Yep, yeah. And you know, maybe we can jump straight into the piece, the clinical trials piece of that, because I think there's a way that you could see the broader landscape of healthcare adopting digital very, very quickly, but then clinical trials is always this microcosm of the broader healthcare space where adoption of new technologies tends to happen a little bit. Let's call it less fluidly. I won't say it's slower, because there are, I mean, I guess it is kind of slower, but there are companies that are really on the leading edge of this and trying to go digital very, very quickly and broadly adopting new capabilities, new new ways of using AI new ways of using site facing technology and patient facing technology. But as an industry, I think you and I agree, and we've been we've been in some of the same forums over even the last couple years, where there's a push for new technology in healthcare, and then you see the clinical trials part of that being dragged through kind of kicking and screaming? Yeah, go ahead.
Jennifer Goldsack 13:40 You know there's a the timing of DiMe gives me this access to the history of embracing digital the clinical trial side of the house and the healthcare delivery side of the house. So when we founded dive in the spring of 2019 we were much more active in the clinical trial space. There was real appetite and interest in digital endpoints and the development of remote sensing technologies that could be deployed to capture data and information outside of the trial site, recognising that there was an opportunity to capture high resolution data about facets of an individual's life, with and without a novel therapy that is much more meaningful than anything that we could ever capture in a snapshot in the clinic. And there was real dedication and determination. Then there was this sort of interesting moment through the pandemic, which obviously none of us could have predicted for DiMe. This was a moment where we had the opportunity to step up and. Really deliver the support that we'd always promised to the full ecosystem on a much, frankly accelerated timeline to what I think I had imagined in 2019 but we have a tremendous team. We have a tremendous sort of group of partners who really, truly lead in this industry. And we were able to do so. So at that point, we started working not just on the use of digital technologies in clinical trials, but really started thinking about full stack of technical solutions coupled with clinical expertise to deliver virtual first care approaches. We started looking at the same tools that we've been considering in clinical trials, deployed in the service of remote patient monitoring as part of routine care delivery, we started to think about sort of risk profiles and preferences, and what can and should we be doing in the clinic? What can we rely on through sort of self report or the use of sensor technologies? And then, how can we also think about other services, so different imaging facilities or home based sort of lab collection, and we really saw enormous progress through the pandemic. But then what was very interesting is since then, healthcare delivery has only hit the gas in terms of their ongoing adoption of digital technologies, meeting patients where they are in order to care for them, instead of waiting patiently in a brick and mortar facility for them to show up on the doorstep. And yet, there seems to have been a bit of a regression to the mean, from my perspective, on the clinical trial side of the house. And we're less ambitious, I think, than we were in 2019 when it comes to using these tools and technologies. And you know, in the last 18 months, two years, there's obviously been this second wave of digitization, powered by AI again, healthcare delivery, grabbing it with both hands. Our payer colleagues really thinking about, how do we sort of really optimise the patient journey? Whereas when I look at how we're thinking about deploying that on the clinical trial side of the house, we're nibbling around the edges. It's about or, you know, can we use agents to reduce our legal bills? And can we think about shoehorning these technologies into exactly the same protocols we've always used, instead of fundamentally thinking about transformation? And that really feels like a missed opportunity, a missed opportunity, not just for the patients we're trying to develop novel therapies for, but also the sustainability of the industry,
Anthony Costello 17:13 Sure, and this is, that's exactly what I was trying to get at. I think you make a great point, and it's a it's a paradigm that we all witness in this space. But I'm interested to get your take on on the root cause, right? So there, there's an inertia in the conservatism of the clinical trials industry, and there's good reasons for it, right? We're dealing with a very a heavily regulated process, a very complex global landscape with different regulatory bodies and different ways of managing data and patient privacy, and the types of studies that can be conducted in one place might be very different than the types of studies and technology that you could use in another place and so on. There's plenty of good reasons, and there's plenty of inertia behind this. These are the ways we've quote, unquote, always done it. But when you see so much new technology, and I'll use, I'll use AI as the latest wave, right? So I agree with you, we saw a real willingness to do things differently during covid. Then we saw a regression. Now maybe we're seeing another mini wave kind of blow through the clinical trials industry with a willingness around the use of new types of AI technology, sometimes for your for your legal for your legal work, but also in in the honest to goodness patient data collection and management, there's a lot of very cool AI that's come on into The into being. You know, commercialised over the last year or two, and Pharma is starting to use some of these newer capabilities in clinical trials, but as you said, at a much slower rate than the rest of healthcare so, you know, besides our favourite old excuse of we're heavily regulated. What Why else is this inertia? So you know? Why does it have such a stranglehold on our industry? And what do you see from the DiMe perspective, working with all these different constituents you mentioned earlier, like, what do you see there that's maybe a sign of hope, or I like to, I like to use the term willingness that we have all the technology in the world we need, willingness to actually use it as the key ingredient to kind of move clinical research adoption into the same kind of zip code where healthcare digital has already been and is going even faster.
Jennifer Goldsack 19:48 Anthony, I really like the willingness language, and if I sort of chart the discussions that I've had with leaders in the field over the last six or so years, I think there was a real willingness and a real curiosity pre pandemic. During the pandemic, in order to do this work, pre pandemic, we had economic tailwinds in the industry. Things were going well. People were curious. They had budgets and I think, flexibility to sort of probe opportunities for ongoing improvements and differentiation in the market going forward. Then there was innovation driven by necessity during the pandemic. But what we have seen in this sort of post pandemic period, and frankly, you know, 2025, in particular, there's been some a new set of sort of economic headwinds in medical product development in particular, is, I, it is my opinion that the incentives don't exist in order to make investments and take risks that will ultimately end up re engineering the clinical trials process that each individual who has decision making responsibility and sort of a budget to manage, is thinking about making sure that their team isn't wiped off the board the next time budgeting is done. And it is my opinion that that drives a set of decision making, which is I need to guard against a downside risk of failure, and we operate within an industry with a 95% rate of technical failure. So if I do what's always been done and I failed, I've done what's always been done and I failed, you can't hold me responsible. But if I try and introduce new streams of data, even if they promise to reduce trial timelines by up to 18 months, which we've proven in publications with colleagues at Tufts, if we try and introduce a new trial design like leveraging a synthetic control arm, and it doesn't work, then my job's probably gone, and my team is probably sort of terminated. And so I think the challenge that we have is that we don't have the right incentive structures in place in order to actually encourage investment and embrace of new methodologies and new tools that frankly, I think we need to embrace in order to continue to have a commercially viable industry.
Anthony Costello 22:41 Yep, yeah, I love the way that you put it, because you're right. There's sort of this invisible hand, if you will, that sort of blocks this innovation out of a sense of, I don't know. I mean, it's conservatism, of course, but it's also almost, as you said, a sense of of self preservation, right? Like the industry fails at an alarming rate, and so that's the status quo, and it's more dangerous. I mean, I really love how you put it, it's more dangerous to try something new that could be a home run, because as long as you can just sort of get the same single that everybody has always gotten before, then you're actually safer. And there's this, there's a little bit of, kind of a myopic view of these clinical development programs that's pretty short sighted, right? I mean, the kinds of technology that we're working with customers on adopting right now at Medidata, and I think DiMe is no different. These things take a little bit of the long view, right? How do you re engineer a clinical development program over a few years to to have a sea change? And it can be very, very challenging to do that in small, incremental steps, working through relatively conservative study-by-study approaches.
Jennifer Goldsack 24:00 I think that's exactly right. So Anthony, we have had a wonderful partnership for many years now with our colleagues at the VA so the largest integrated healthcare system here in the US, and one of the things sort of born out of some of the pain that we're talking about here in clinical trials that we put together with them, was what we described as a value based innovation framework to actually say, how do we know if we're getting value from innovation? And one of the most salient pieces of that framework is this notion of time to value realization and when you are being innovative, it is rarely that the full value is felt in the short term. In fact, we can think about the fact that oftentimes you are so if we're looking at it cold hard. Dollars that ROI is often negative in the short term, because you have to make investments in the infrastructure, the ecosystem, in training individuals and change management, all of that has to be done before you can start reaping value. And so one of the things we did there was to actually think about what are short term milestones that we can almost use as sort of predictors, or if we want to keep, in our clinical trials parlance, sort of surrogate endpoints of pending success or likely success. And then what are we looking at in the medium term? And then real talk, what should we expect in terms of long term outcomes? And can we start tracking those now so that we can see whether our hypotheses and our assumptions around short term markers as predictors of long term going to use your language home runs is actually born out. And that's been really powerful for our colleagues at the VA. They continue to use that framework. And I think it's really interesting to think about how we might deploy this notion of time to value realization on the clinical trial side of the house. How can we think about what we need to invest today, and how can we think about how that's going to return to us in terms of timelines, dollars and cents? But also, let's start to think about it. What are the new label claims that we can make that might change a pricing and reimbursement decision in an era where we know pricing and reimbursement decisions, not just in the US but globally, are going to look a lot different. They're going to require different evidence than they ever have before. How do we think about the fact that if you're not a first mover to start to embrace these technologies, you are going to be lagging behind with internal technical expertise, with experience, the data we collect increases exponentially, and our ability to use that data to drive hypothesis generation for the next round of sort of discovery that we want to do, we disproportionately fall behind the longer we wait to embrace these technologies. How do we start to build that into a decision making framework such that a medical director might actually have incentives to look at different approaches, as opposed to practice defensive sort of clinical, you know, clinical trials planning, because he or she is a good boss and wants to save their team. I can't fault the decision making. I actually think we need to look at the sort of executive level to say, how are you actually thinking about maintaining your organization for the next five years, for the next 10 without leaning into this innovation, without thinking about data and experience as a differentiator in the market?
Anthony Costello 27:29 Yeah, and I think that that reminds me of a couple of things that you and I have talked about on other occasions, which is the the plan B, right? Like, what is the plan B if we don't adopt some of these faster, better ways of running an entire clinical development program because of this conservativism that we're talking about, or the lack of willingness maybe can. Can the industry continue to to operate at this rate? I mean, can we continue to have 10 year long life cycles to bring a new drug to market and 10% of clinical trials being successful, one in 10 drugs making it all the way through at the cost of hundreds of millions of dollars. And how do we, on the one hand, you know, discover more and more pipeline opportunities through the use of AI at early on the kind of early side of the spectrum, right AI around pre clinical molecular discovery and sorting out the best candidates to go into clinical trials could potentially flood the industry with lots of ready New Opportunities, only to bump into a clinical trials infrastructure and process that simply can't sustain it, or can sustain it at much too high a cost and much too low a success rate. So what is the alternative anymore? Jennifer, I guess I'm asking like, at what point do we just have to get out of our own way to make this industry really look different before it crumbles under kind of its own weight.
Jennifer Goldsack 29:16 I think we're there. I think we're there if you are embarking now on a new you know you're just moving a molecule into first in human I don't know what economic model you could run in the era of no more cross subsidisation for basic biomedical research, in the era of the inflation Reduction Act and drug price negotiations, in the era of most favoured nation pricing. We don't know whether that will be. Hold up in the courts, but let's assume it is and the pressure that the United States is putting on other countries to think differently about their pricing and reimbursement models, I don't know that there's a model that holds up that could justify developing a molecule at all given a 95 or a 90% technical failure rate, $100 million price tag, and a sort of 10 year development timeline. I think we may be unwilling to run the models and actually see whether that's the case again, sticking our head in the sand a little bit, but I think there are two things to consider. There are organizations out there who are leaning into innovation, who are thinking about, how do we leverage the data that we already have? How do we make smart investments and find smart partnerships to access more data so that we can get ahead, build our experience, make data driven decisions? There are organizations out there who are designing trials in a different way so that you can actually recruit because the other thing to remember, and I'm going to go off at a tangent for just a second, I acquired over winter of the sort of 2024 25 the unfortunate baggage of Becoming a cancer patient myself, I see the crappy posters in the cancer centre with a QR code that's photocopied so badly you couldn't even pick it up around trial recruitment. We can't keep doing this. We have to patients are going to expect different things, because patients receive clinical care in a different way. They can't then come in and use a clipboard and 25 pages every time they have to go into the to the clinic. That's not going to work for a clinical trial. We think we have recruitment challenges now. They're only going to get worse. So to answer your question, I think we're already there. I think the problem is, isn't that not everyone realizes that, and that those organizations who are thinking strategically and making build, partner, buy decisions as it relates to innovative data sets, tools, trial designs, are exponentially going to pull ahead in the market. And I don't think everyone survives. And I think there's probably a one year or 18 month window for life sciences to get on board with this, or I don't think they make it back and that's really not overstated.
Anthony Costello 32:15 I couldn't agree with you more, but I'm, I'm glad to hear you say it. And you know, I the industry has had a focus on patients for at least in in term, in lip service for a long time, but there really are so many better ways. I mean, I'm I'm very sorry for the struggle that that you're going through, and I'm sure that the perspective that it has given you is just something that is impossible for anyone to understand an industry that hasn't lived through it, that hasn't lived through what you're going through right now, and that perspective, I think, can shine. I mean, I want to, I want you to talk about it if you're willing. But how you know when you really understand the way patients perceive our industry, and the way patients go through a clinical trial, or try to even understand what a clinical trial can bring to them and what the cost benefit analysis may be for them. It really changes. It really changes the outlook and kind of the pressure that you want to put on an industry in order to change when you understand that perspective, I think, is just different than than anything else that we can intellectually sort of contemplate from the perspective of industry.
Jennifer Goldsack 33:37 Yeah, and I think the most simple way I can perhaps illuminate the patient perspective on the clinical trial process is when I go in and, you know, I have got late stage colon cancer. There's nothing fun about what I'm going through right now, and I what, but the treatment protocol I'm on is working, and Anthony, I have two thoughts in quite short order. Every time I go in to review blood work or scans with my oncologist, I have been lucky enough, despite a really challenging journey, that every time I've had that conversation, things are moving in the right direction. So it's a long slog. It's a horrendous journey. Wouldn't wish upon any, anyone. The first thing I think when he tells me, you know, good, we're seeing tumour shrinkage, or like the blood work's looking good, my first thought is, one, thank goodness. And then two, and thank goodness, because otherwise I'd. Find a clinical trial. And that is genuinely my response, the fact that there is a proven protocol that I can access locally without what I know to be the burden of having to, one, find two, get into and then three participate in a clinical trial. I think how lucky am I that I do not need to go down that road right now and and it's not like a proven protocol and a simple care delivery sort of process is easy, but I I know how much worse it would be if I was trying to do this on protocol. And it's interesting too. I was actually at the Kansas State clinical oncologist annual meeting just this weekend, I gave the keynote, and I was speaking to oncologists who work outside of academic centres, and they're pretty much ready to walk away from clinical trials at this point, there was one chap. It was a Saturday morning that the event was held, and he said, the day before, he'd recruited a patient to a clinical trial that they'd been on him for not getting more patients in. They were spending so much money trying to screen for it this and the other. And then him and his team finally got one person onto protocol the previous day, and he said it took us hours, and I got to the end of it, and I thought, I don't think it's worth doing this anymore, for what they get in terms of remuneration and for the burden it puts on him and his staff. Even though he wants to provide access to clinical like, to provide his patients every option, he runs an independent practice, he can't do it. He literally said to me, I don't I don't think we're going to keep doing this. And if that's my perspective from the point of view of a patient, and if that is within the last 72 hours, what I'm hearing from the kind of clinical teams who actually provide access to clinical trials so the patients who need it most. This is not a problem of the future. This problem is really here today.
Anthony Costello 36:37 Yeah, yeah. Well, and there's so many, one and done in you know, investigators and investigative teams around this industry, and has been for a long time. So, I mean, Jennifer thinks again, I'm sure I can speak for all of Medidata and all of our viewers, and we're, you know, sorry for what you're going through. I know you're super strong, and I'm sure you're fighting it with like every bit of strength you've got, but thanks for kind of bringing that to the podcast and keeping it real and talking about something that you know is is obviously a challenge, but but also something that's useful for our viewers to have an understanding around. Because if you're you know, think, thankfully, you're not at a point where you need the clinical trial. You're highlighting that as a as a big positive, obviously, but so many patients have no option but for the clinical trial. And we know, you know, we have a lot of patients that we work with here at Medidata, and we've lost a lot of patients over the years that we've worked with because they've thrown their, they've thrown, kind of their last chance at a clinical trial multiple times and not been successful. So I think you know, really, it helps keep you know our mission, and I'll speak for myself, like it helps keep my personal mission here, kind of very focused to think about, how do we make sure that our industry is performing at the absolute highest, highest standard and highest possible success rate we can achieve for people like you and so many other people like you that may ultimately have this as their as their last option.
Jennifer Goldsack 38:36 I know, and you know, there's a couple of things, Anthony, I mean you and I have spoken about this. You and I have actually lost our minds sitting in a room somewhere in DC at a government hosted event where people were starting to get excited about the possibility. And I think this was only the beginning of 2024 gosh, now maybe we may, we might be able to do clinical trials matching and as it turns out, as as we chatted afterwards, we were both about ready to throw ourselves out the window at that moment. I mean, first of all, if this is being held up as the cutting edge of innovation, boy, are we doing our messaging wrong as an industry, because this has been around for the best part of 15 years. This is a problem that is so easy to solve, even with today's messy data sets. This is this is a solvable problem. We also know. And I go back to if I needed a clinical trial, I'm not sure that finding the clinical trial is the problem. It's the fact that they may only be enrolling in Seattle and Chicago, and I live in Sarasota, Florida, and no one is going to take. Like my labs, no one is going to look at the sort of genetic tests that I've done. No one is going to look at my imaging from the local facility, and no one is going to do a telehealth screening visit with me. I would have to, in a moment where I was fighting for my life, where no treatment on the market is working. I would have to figure out how to pay to get on a plane to go to have all of those images repeated. And let me tell you, there is nothing elegant about how they do scans for a GI cancer. It makes me weep every single time. And the idea that I would have to do that again for sort of gratuitous it has to come from our site. Decision making is, I think, an abomination to patients, and then we could get there and it could not work, and time is ticking, and it is not the matching that's the issue. We have to think about true ability to reconcile data from different sites. We have to think are about our ability to use every single part of the tech stack to do things like virtual visits. We have to think about all of these different pieces. That's the limiting factor to using these powerful new tools in the toolbox to get everyone who could and should be on protocol onto protocol. It's nothing to do with our ability to find patients or to find trials. That's not the limiting factor, and it's just it's so incredibly frustrating. The other piece is in oncology in particular, and in fact, rare diseases as well. FDA has accepted synthetic control arms for the best part of 30 years. It used to be that it was a bunch of residents going through paper charts in order to find matched patients, and then your statistician on their non networked computer would model them. But this is something that we have many approvals on. In the US, in Europe, in Asia, we have relied on synthetic control arms for a long time. There is very low regulatory risk associated with this, and as a patient, don't put me into a randomized control trial if there is a possibility to model the control arm. First of all, you half the number of patients that you need to recruit. So you can be so when the drug gets onto the market, it can sort of be at a more accessible, more affordable price point. We can half the amount of time it's going to take to recruit, so time to market, time to cure and don't put me into the control arm. If there's enough data that already exists for a patient who looks like me, put me into the intervention arm. These are the sorts of pieces that we're just there is no logical reason not to be doing these things. And I think we have got to the point to circle back, Anthony on the conversation, and I think the points that you were making earlier about sort of, where are we in terms of getting to, you know, that moment of criticality, I think we're here if we don't do this now, how does our industry sustain itself? That I've yet to find someone who can answer that question for me, and I think in particular, for those organizations and for those leaders who are slow to move, you're going to get left in the dust because you are going to miss out on exposure experience, conversations with regulators building your data lakes in order to do this more efficiently in the in the future.
Anthony Costello 42:57 Yep, yeah. And I think this is why the word willingness always comes to mind for me, because you're, you know, there's an interesting paradox in what you're pointing out. You know, these are both solved problems. Like you said, it's a solved problem to know how to find a matched patient, but, but yet, the problem's not solved because we don't do it in the right way, or we don't allow enough decentralization for that patient to participate remotely, or we can't get out of our own way on the technology adoption, or even just the data sharing right, even just not making you repeat a scan or a lab because we have ways to share those data across institutions, for example, or for you, you know how much longer before you will just personally control your own data, and you can volunteer it up for anybody you want to to aid in your own diagnosis and treatment for your own disease, right, Like will, will we ultimately get to the place where willingness on the part of pharma for adopting new ways of doing things almost becomes secondary to what the patient's willing to do on their own behalf to drive their own the awareness about their own data that they control for themselves. I mean, I think that could come faster, if you know, and some of the things that we've seen over the last few years make me wonder if patient data sovereignty and patients controlling controlling their own medical history and their own data will actually come faster than some of the industry turnaround that i. Think we all expect to see in the next few years, but we don't know how fast,
Jennifer Goldsack 44:41 you know, and this is actually Anthony, what I need to be really careful, because I am having a very personal experience as a patient, and I am not a trained or qualified patient advocate, so I really speak only for myself. I am not trained or an expert to speak on behalf of others. But you know, it makes me personally nervous that there is so much friction within industry that we may actually default to burdening the patient in that way. And I was very intentional there in my word choice, which is burdening the patient I have, I've had referrals where I have had to go, even within my local neighbourhood, I have had to go and get a CD ROM burnt, and I have had to then bring that to the next appointment. And I'm smart enough to know to ask, as I'm scheduling, do you have my images. Oh yeah. Well, the they faxed, they faxed it over. And I'm thinking, you can't fax an image. You can fax a radiologist report, but I want you to look at the image. So then I as a highly sort of health literate individual, no, no, do they have the images? And I will sit on hold while they go and look and see what they've got. And I'm like, right? Well, then we can't schedule for tomorrow. We have to schedule for next week because I have to go and get a CD ROM burnt, because there's absolutely no way, apparently, for you to be able to port this over, which is also ridiculous. There are so many tech solutions for that like that is an enormous burden, and I'm not doing it within the within the construct of a clinical trial or medical management across multiple institutions. I have been lucky enough that as complex as the journey I'm on is, I do have a quarterback in my oncologist, and the majority of data and the majority of referrals sit within that Institute. The few occasions where I've had to go elsewhere, it makes me think I do. I'm sick. I'm trying to work as much as I can. I do not have the time or the appetite to be doing this. This should be a problem that is solved by the system. And I think in particular, when we think about how, again, I'm going to use my words intentionally, pedantic. Teams are about data sovereignty. And, you know, do we have a you know, there's no way. No way. As an overstatement, I would be very surprised if there are clinical trial teams who are willing to accept data that a patient hands to them, because then what they don't have is clear timestamp and sort of history of where that data came from. And so I think if we are so conservative as an industry that we don't drive forward, and we default because it happens on, you know, because the healthcare system is ahead of us, and on the healthcare side of the house, we make the patient the quarterback for their data. It's going to hurt us even more on the clinical trial side of their house. And my personal opinion is that we're not doing patients any favours either. We should have a system that allows data to flow with the appropriate permissions wherever it's granted.
Anthony Costello 47:55 Wow, that's a great That's a great story. And I agree with you, I think, and I think there's a way that we can have both things. We need to both. In my view, we need to both fix the system in fundamental ways. And I think part of what patients are beginning to discover and we'll discover even more over the over the coming years, is that the the advancements in technology health records management apps on your phone that can consolidate all of your medical history from multiple institutions into the same place and then surface insights for you using AI in the same way that your doctor might surface insights for you, like these things are all going to change the way patients engage in their own healthcare and their own health journeys, and there just is no way that that doesn't bump up into the clinical trials market as well, maybe even more so, because many patients that are needing a clinical trial have a sort of 10x heightened awareness of their condition and how to kind of put all the puzzle pieces together and try to understand the prognosis and the remediation opportunities that they may have, right so there's even more interest in doing the analysis of that history of data, and for the first time, we can make those things available to patients in ways that they've never seen before. And I find that really exciting, and I'm. I'm anxious to see sort of what the next few years brings in terms of data, independence on on not that we want to shift the burden to them, but that patients, more than ever, have the same tools to understand their own disease in a way that they never have before.
Jennifer Goldsack 49:52 Yeah, and I mean, you think about things that we're just remarkably bad at as an industry when there's no reason for it. You know, return of study data to the patient at the end of a trial, right? These are the sorts of things that we can do, and we can do really well with today's toolings. And you think about what a difference that makes to the patient. I was chatting to a friend, actually, who's also a clinical researcher. And to make this as vague as possible, what they do is they've actually started putting consent forms into chat GPT and asking for a one page, plain summary language, and the patient still goes through the consent process with the coordinator, and they use the one pager, and they send the patient home with a one pager like these are the things that are important, right? Your remote monitoring is not safety monitoring. So if you experience anything cool, it is not the legalese. It is not page 13 that by which point your eyes are glazed over in big capital letters as a paragraph yelling at you about something that's nothing to do with your clinical care. It's all cover-your-ass language from the sort of many, many rounds of legal review that these documents go through. And it's just sort of interesting to start to see those little signals in the data. And you think about how we can really, really transform the experience, and we have to. And and frankly, patients deserve that. Like you said, anyone who's seeking out a clinical trial deserves our respect and deserves our best effort.
Anthony Costello 51:26 I could talk to you all day long, but I think we've got to, we've got to bring this thing to to a close here. So, you know, we always end the podcast with a little bit of a crystal ball view of the future from Jennifer gold sack. So, and in your case, I want to tweak it a little bit right? So we want your crystal ball view of where you think the industry is going. But I also I want you, if you can, if you're willing, I want you to give a directive to the industry. I think you've earned it. I want you to give a directive. What do we all have to do for you and for you know cancer sufferers all over who may be reliant on a clinical trial or just reliant on standard of care and a healthcare system that can understand them and empathetically help them on what's obviously a very complex journey. What's your directive? And then I'm gonna go make everybody do what you say.
Jennifer Goldsack 52:33 I love it. So you're going to be the Enforcer. I'm here for this. So I think, Anthony, it's quite simple. I think that I implore, frankly, our colleagues in clinical trials to recognize that the risk of not embracing innovation, the risk of not embracing access to flows of data from both inside and outside of the clinic and the powerful new set of tools that we have in the toolkit in the digital era, the risk of not embracing those things far outweighs the risk of trying something New. I would ask executives to think about how you message that and how you incentivize that. And I would ask for anyone with decision making or Budget Responsibility to have the courage to innovate on behalf of the patients that our entire industry exists to serve. And the second piece, maybe more crystal ball than directive, is we talk to enough people here at DiMe to know that this is happening. It people may not be as vocal, but there are leading organizations that are making these investments and are making these decisions. They will pull away and leave the rest of the market in the dust, perhaps not as successful commercial entities, if we don't act now. So it's not just to change the risk calculus, but to do it quickly. Anthony Costello 53:57 Yep, yeah, we see it too. We see it too. Yeah, there's maybe we didn't give enough air time in this podcast to those organizations that really are forward-leaning and really trying some new things. And you can already see the pull away. You can already see the pull aways.
Jennifer Goldsack 54:11 Yeah. Youu can. You really can, and it will only happen at an exponential pace.
Anthony Costello 54:18 Yep. All right, Jennifer, we'll leave it there. Thanks again so much for being here today and bringing your expertise and also bringing your real story. I think it really hits home. It's. To kind of bring it, bring the reality test of what it really takes to go through this kind of a struggle the way that you are, and we're all with you and here for you. So take care of yourself. Thanks for your partnership. Thanks for being on the podcast, and please let us know if there's anything we can do to help.
Jennifer Goldsack 54:52 I really appreciate that, Anthony, great discussion today. And you know, I talk about those leaders in the field who are beginning to pull away. Certainly, Medidata is one of our most innovative partners. And when we're thinking about how we benchmark success, I always think about some of the case examples where we work together as being at that leading edge. So thank you, and let's keep pushing.
Anthony Costello 55:15 Let's do it. Thanks. Jennifer, see you soon. Bye, bye. Thank you for tuning in to today's conversation. If you've been enjoying this podcast, please subscribe to our YouTube channel and follow us on Spotify Apple or wherever you get your podcasts. If you have questions for me or thoughts about the episode. Drop them in the comments. I do read them. Thanks again for listening to from dreamers to disruptors, and we'll see you again next time.