Sabine
This podcast episode explores the transformative potential of digital endpoints in clinical trials. These endpoints can revolutionize our approach, helping trials focus on the data that matters most to patients, regulators, and to payers. The FDA’s recent qualification of the first digital endpoint signals that the healthcare research field is embracing more technology and advanced methodologies.
However, the adoption of digital endpoints still faces significant challenges. Many healthcare decision makers may struggle to understand the tangible benefits, lack clear use cases, and have concerns about implementation. That is why in this episode, we are focusing on a recent initiative led by the Digital Medicine Society, DIME, as part of their digital health measurement collaborative community. It’s titled, Building the Business Case for Digital Endpoints.
It explores these challenges and opportunities guided by insights and from experts and the latest initiatives. They are developing a framework and resources to help build a compelling case for continued investment in digital strategies, aligning with business goals and industry standards. They are providing a forum for collaboration where partners and experts from across the digital field are working to advance the use of digital health measures in research to ultimately improve lives.
Many of us see the transformative potential of how these digital endpoints could in the future help sponsors deliver clinical trials with shorter durations and smaller sample sizes. This would be such a significant leap forward in enhancing clinical trials.
So today I’m joined by two guests, Victoria Bangavia, program director at Digital Medicine Society and Lauren Alani, the director of digital innovation at Seuss+. So Victoria is a licensed clinic. Victoria is a licensed clinical psychologist. who works at the intersection of clinical science, technology, and advocacy to advance clinical research and healthcare through the integration of digital health solutions. She has over eight years of experience in the digital health industry, designing, developing, and dissimulating digital measures and
Disseminating Digital Measures and Therapeutics. Victoria is a licensed clinical psychologist who works at the intersection of clinical science, technology, and advocacy to advance clinical research and healthcare through the integration of digital health solutions. She has over eight years of experience in the digital health industry, designing, developing, and disseminating digital measures and therapeutics. Through these efforts, She is dedicated to increasing adoption of digital health solutions in routine care and clinical research.
Also with us today is Lauren Alani. After receiving her bachelor’s of science in medical microbiology and immunology, Lauren spent 14 years in business development across pharma, medical devices, and life sciences software.
Here she acquired a healthy understanding of the challenges organizations face when facilitating efficient and effective and engaging clinical trials. And over the last five years, Lauren has focused on how advances in digital innovation can help mitigate risk and enhance the likelihood of successful clinical trials, bridging the gap between trial requirements and the value delivered by clinical technology. During this time, she also chaired the e -digital thought leadership group for ACDM. she also spent some time volunteering as the head of the intelligence unit for the HBA.
Sabine
This is the first, the first time that Cut the Chat has actually had two participants and individuals that I’m interviewing. So welcome, Lauren, welcome Victoria. It is such a pleasure to have you both here today. And I am thrilled to be talking about this fantastic project around digital endpoints, the talk of the season, right? So we’re excited to dive into this and to really hear your thoughts. We’re going to cover some of the basics and then get into some details. Victoria, I’d love to start with you. And if you could share with the listeners, you know, why this project? Why are you? What are you looking to achieve? I’ve got like five questions and one for you. Why this
What are some of goals that you’re looking to achieve? share some of your decision making around choosing your partners.
Victoria:
Yeah, thank you so much Sabine. And first, I just want to say it’s so great to be here with all of you. So yeah, the project that we’re working on as part of the Digital Medicine Society’s pre -competitive collaboration is focused on making the business case for using digital endpoints in clinical trials. First of all, DIME is a research organization that is focus moving the field of digital medicine forward. And as we all know, so much effort goes into the development of digital health technologies. And there’s also a lot of promise and benefits in using digital endpoints in clinical research. But what we’ve seen is that their adoption has been quite slow. And the goal of this project really
what it comes down to is to increase adoption of digital endpoints in clinical trials. And we hope to do that by showing their value, by being able to demonstrate what the business case is in using digital endpoints in clinical trials. And what DIME does so well is develops open source resources that are user friendly and easy to use and effective.
And ultimately, what we hope to come out of this project is providing some of these resources that teams within sponsor organizations and tech organizations can use to actually make the business case for why digital endpoints should be used in trials. And yeah, you bring up also good point about our partners. We’ve got a very
diverse group of almost 40 organizations that are working with us on this group. It includes sponsor organizations as well as the med tech companies that are actually developing the technologies that are used as well as some academics and researchers and
Victoria Bangieva
regulatory. FDA is an organization that we partner with closely and so it’s nice to have their perspective on this project as well. And the reason that we’ve selected this group or brought on these specific partners is because, you even though we’re focused on the business aspects, which probably touch the sponsor organizations the most who are actually at the forefront of deploying these digital endpoints in their trials.
There’s so many various stakeholders who are affected by the use of the drill endpoint. Whether it is the companies that are actually focused on their development and they need to know what is important for the sponsor organizations. How are they to be used in clinical trials? And similarly for so many other stakeholders as well. So we really just wanted to have varied opinions at the table.
and to hear from all of the various stakeholders to inform how it is that we are thinking and ultimately what it is that we would be sharing with the broader community once we complete the project.
Sabine:
Yeah, I was very impressed with the list of partners that you’re working with. It’s quite a diverse group. And I think that that’s something that is going to add so much value to the entire project is getting that diversity from large pharma to consulting companies to tech companies. So fantastic that you’ve picked such a diverse group. know, Victoria, maybe I should go back maybe just to cover some of the basics. And, you know, I think a lot of our listeners know and are aware of digital endpoints.
But could you just give us a brief definition around what are digital endpoints and really what is the significance of
Victoria Bangieva:
Yeah, and that was actually the very first place where we started with this project. We wanted to define what exactly is it that we will be focusing on, working on. What’s interesting is that I think endpoints, everyone is quite familiar with what that refers to and what that means in clinical research.
But the digital endpoint aspect is quite new to the field. so DIME, which actually hosts a glossary on our website, has now incorporated a definition for digital endpoints as well, which we define as a precisely defined variable intended to reflect an outcome of interest that is, one, collected digitally with a sensor, and two, statistically analyzed to address a particular research question.
So this definition doesn’t veer too much from what the definition of an endpoint is, but it does incorporate that digital aspect. And so in just some layman’s terms, what this means is that it is an outcome of interest that is gathered via a sensor. And the sensors can be embedded into wearable technologies, as well as applications on our cell phones. And ultimately,
It is data that is gathered digitally. And why is this important? Because as you know, I’m sure we’ll talk about a lot today, there’s a lot of benefits to this kind of data. It is data that is able to be gathered continuously, real time, and it’s gathered in the patient’s natural environment, which provides unique benefits to
seeing the patient in clinic or in person and gathering data in that manner. So because of that, the data tends to be richer. There’s a lot more data to work with. And a lot of times it’s a lot more sensitive than what is, you know, what is perceived as sort of traditional way of gathering data. So that’s where I think a lot of the benefits of digital
health technologies and digital endpoints specifically come in. And, you know, I’m sure we’ll be talking more about kind of how these benefits translate into all of this, but just to kind of give some context then.
Sabine:
Yeah, definitely.
Sabine:
Great, thank you very much for that really great overview. And Lauren, we love our clinical space, don’t we? And I know how passionate you are about this topic as well. But how do you see digital endpoints really changing the landscape of the clinical trials that we’re working in? And if you kind of look to traditional methods.
Lauren Alani:
Yeah, of course. So Victoria mentioned some amazing benefits, which is of course the richness of the data and how that really translates to clinical is this opportunity to actually increase the frequency and volume of data being captured. So really talking to those unique data points that Victoria mentioned as well. And what this opens up the possibility for in clinical research is the possibility capturing continuous and passive data capture, which gives a lot more colour to the actual experience that the participant in the trial is going through, because it’s also capturing what happens in their home, not just at the more sparse site visits. And it’s, as she also mentioned, it’s around that more natural setting. So we’re capturing something that’s a lot more realistic. And to give an example about what really translates to, it’s things like comparing it to a six minute walk test, which is done, of course, on a treadmill. Now that is quite different to how a participant would usually walk generally in their own home. Whereas we’re using a wearable and capturing that home data, then we’re actually capturing them popping to the kitchen to make themselves a cup of tea, which is a lot more natural than they would otherwise be doing on a treadmill.
And what this offers as clinical trials and as sponsors is the ability to improve participant safety in clinical trials, as well as improving the amount of data we’re capturing on efficacy as well, which directly translates to improving our likelihood of success of showing the possible impact that that treatment option is having on the participant.
Sabine:
Fantastic. Very, very interesting. And do you see, we work a lot with biotechs and I think biotechs are definitely also organizations that it’s very interesting to pull into this research. And how do you see them actually impacting the use of digital endpoints?
Lauren Alani:
Yeah, so I think this is a really critical point. And it’s one of the reasons that we actually are working with the Digital Medicine Society and have actively agreed to participate in this project, which I think is going to be incredibly exciting and impactful for our industry. And the reason being is because the biotechs I see as being primary champions for innovation and more than often than not, it’s becoming an actual actually an expectation of them from potential partners and investors that they do look for these innovations, so much so that it’s largely becoming a requirement in order to survive as a business. So they have to constantly innovate to in order to to increase their chance of likelihood of achieving financial funding to continue their work. And We also see that they are taking on this opportunities with vigor. And, but they also don’t have the resources necessarily to really understand what other organizations are doing, what digital endpoints are being used. And as an industry, we’re not very good at sharing what lessons can be learned. So we also see that being an innovator is actually really hard and that more support is needed. For them because we see that quite often they’re the ones that bear the brunt of the lessons being learnt and also getting their fingers burnt. So I think there’s a lot more support that we need to do and that’s certainly our role in the project is to ensure that we keep that good link in with biotechs.
Sabine:
Do you see this as one of the hurdles and could this be a call to action potentially as well for to both of you to call out to biotechs who are interested in participating and also sharing their stories and their experiences?
Victoria Bangieva:
Yeah, you know, I think what we are focused on this part of this project is hearing exactly from these types of organizations, whether it is the large pharmaceutical companies or the biotechs that are focused on executing clinical trials. so, absolutely, if…
there are opportunities to hear from them. would love that and be open to that to help really inform how it is that we’re thinking about the deployment of digital endpoints and what their value is from the large pharma companies to the smaller companies. We ultimately want to help the industry as a whole. And this is where I think biotechs as well as any other
company that is focused on producing clinical trials has a really important say in how their work is affected by digital endpoints.
Lauren Alani:
Absolutely. their challenges are different to Big Pharma, which is why I think it’s so important that we do keep that good link in, because they’re the ones that, you know, they are moving ahead and adopting these innovative digital endpoints, but then they don’t necessarily have the resources there to support them. So it’s also about, and you mentioned hurdles as well. So one of the main hurdles that we see, because we have a lot of, we work a lot of biotechs who kind of utilize these digital endpoints, which is really exciting and great to see that they’re at the cutting edge of innovation. But some of the specific hurdles that we see quite often is around validation, for example. So actually, in the adoption of digital endpoints, it’s fantastic that they’re exploring that, but then having their fingers burnt because of the lack of validation, which means that without the significant and required validation for their population group that they’re actually using the digital endpoint in, it means that we can’t necessarily use the data, which is critical for them and the success of the clinical trial.
Sabine:
Yeah, that’s such a good point Lauren. We always try to round up with some tips and tricks and I think that that’s an important one for any sponsor obviously is to really ensure that their responsibility is ultimately to have their vendors and their providers who are providing these digital endpoints validated to make sure processes are in place for that. So true. Do you think that intimidates organizations? you experienced that? Either of you? to not work with digital endpoints.
Lauren Alani:
I mean, I would say absolutely, because particularly if biotechs had their fingers burnt in the past, I think they’re less likely to do it again, which is not where I think we want to be. We want to be pushing innovation, adopting more digital endpoints. And that’s why I think it’s really important that the support and we’re increasing the amount of support available for when they’re actually considering these digital endpoints.
It is a big ask because some of the validation that we’ve looked at in the past to help sponsors who are mid study with a digital endpoint that they’ve then realized is not validated for their study population. On paper when we look at, okay, well, what will that mean to achieve validation? Depending on the level that they’ve achieved so far.
towards validation, could take up to a year and cost over 100 ,000 euros. So it’s not insignificant. And this isn’t a cost that’s is expected because obviously it’s a mid study realization of suddenly that has a big impact on your timelines and budget. So that can be extremely off putting.
and for biotechs. But certainly that’s why the selection of digital endpoints and selection of vendors upfront is so important and actually doing the qualification of certain vendors is so important.
Victoria Bangieva:
And I think that’s such a great point, Lauren, about validation. That certainly is a huge hurdle, especially given how new, relatively new, a lot of these technologies are, and we’re just needing more evidence around their validation. Another hurdle that we keep hearing about is we’ve been just talking to more organizations as part of this project and hearing from clinical teams, especially within sponsor organizations.
is some of the operational complexities involved in deploying digital endpoints and digital health technologies. You know, as we’re talking, yes, they’re still relatively new. There are potentially additional trainings involved, additional support involved for using DHTs in clinical trials. And with that comes additional costs.
I think as a field, haven’t yet developed very strong muscle around deploying digital endpoints and doing so seamlessly. So I think with time, certainly some of these operational challenges will become easier and probably not as big of a hurdle. But currently that is another hurdle that we hear about quite frequently.
Sabine:
That’s interesting. Do you see that actually impacting the decision not to use digital endpoints in certain trials?
Victoria:
At times, yes, it does tend to be a deciding factor because people will ultimately want to lean on something that they’re familiar with or already has a pretty clear pathway in the clinical trial. So that tends to be definitely another reason.
Sabine:
think return on investment is always important for key decision makers, isn’t it? mean, there are a lot of aspects to look at. if they are making the decision and they say, okay, I’m going to move forward and willing to look at the investment that’s needed, what do you see as one of the biggest return on investments?
And obviously there are different trials. There could be specific for specific therapeutic areas. But would you say that there’s a general return on investment in using digital endpoints?
Victoria Bangieva:
Yes, there is. And we’ve actually already seen some data reported on this from a few publications that I want to reference here. One is the study that was done by a group led by Hiramori and the study is largely referred to as Project Moneyball and also Dimes recent collaboration with the Tufts Center for the study of drug development, which that study was accepted for publication as well, where we showed significant return on investment in phase two and phase three clinical trials. And that investment was largely attributed to shorter trial duration and lower recruitment costs because of just needing smaller sample sizes. In terms of specifically what we’re seeing on that return on investment,
It does have to do, a lot of it is related to recruitment because digital endpoints just tend to be more sensitive, provide richer data as we’ve been talking about. It allows us to screen patients more effectively at the very start. We’re able to get a much more specific patient population to include in a study. then reduces some of the costs associated with recruitment. Additionally, on that point of recruitment, because you’re getting a more specific patient population, you’re needing less patients overall. So there’s a lot of benefits to using digital endpoints at just some of those early stages around recruitment. We’re seeing directly some of that ROI. And then the aspect around ROI is really captured in terms of the treatment effect. So because the dual endpoints, again, tend to be more sensitive and provide richer data, we’re better able to determine treatment effect and safety of the therapeutic much earlier on in the process. So this, you know, typically informs earlier decisions about the therapeutic allows us to understand their overall treatment effect and safety much earlier on, which can help inform future decisions of clinical development, which can certainly increase additional costs in the future. So the treatment effect is another important aspect here. And to that end, if we’re able to detect the treatment effect earlier, then that means that we can end the trial earlier. there’s this benefit of shorter trials as well because of digital endpoints sensitivity to the overall quality.
Sabine:
Yeah, that’s so true. We see the numbers around every month. What an additional trial, what the spend is on every month. And it’s interesting because often we see that the trials more, they’re change orders that actually extend and extend the trials because of the patient recruitment issues. So this can actually have a very significant impact. And then maybe to do a cost, it be interesting to see a cost comparison. If we were talking about the validation earlier. So how does that kind
cancel each other out, looking at the savings in the long run and potentially even more significant than the costs for some of validation and the beginning stages of the trial. Interesting. And is there data around that that we could also share potentially at the end of the podcast to see some of the numbers around that and looking at decreasing the number of patients required for trials?
Victoria Bangieva:
I would definitely refer everyone to check out the publication that was just published, as I mentioned earlier, the collaboration with the Tufts Center for Study of Development. There’s very compelling data there and I honestly would love to see more organizations reference that in the work that they’re doing in this case. So that would be my first kind of go -to data for the value of digital endpoints.
Sabine:
Yeah, absolutely. We’ll make sure we reference that. We’ll add that to in the notes from the podcast today. So thanks for that. And we’ve been talking a lot about sponsors in this, vendors are also, right? CROs and other vendors are also impacted. if we look into the future, Lauren, if you could give us some insights on this, there are so many stakeholders
What would be your top two or three bits of advice for organizations that are looking to implement digital endpoints in their trials?
Lauren Alani:
That’s a great opportunity to really speak about the future. my top two or three will be firstly to be inspired by the opportunities, either as a tech vendor and the opportunities because of the advancements in technology and what we can actually create. Be inspired as a sponsor by the amazing digital innovations that are being utilised today to benefit clinical trials and ultimately patients. But to ensure that you also have a robust selection process or robust, if you’re a tech vendor, a robust pipeline for your product, to make sure that you are able to really get to the grips of what it is that the study needs and what your clients need, what the patient population needs, and so that you can be very clear on
what it is you want to achieve with the use of it because of course it’s very important that we’re data for a clinical trial that is required and has a purpose, not just because it’s a nice to have. So it’s very important that we’re very clear on the why, so why we’re using it, why we’re implementing it. And once we’ve kind of been inspired, actually done the research and invested and acquired the technology that we need,to really learn from the community on the lessons learned through engaging with organisations like the Digital Medicine Society and all through learning through other experts in order to be able to get that support for your operations because it is challenging and it is new. But the benefits that are there certainly outline the reasons why it’s so important to consider if not to agree to use digital endpoints.
Sabine:
Thanks for that, Lauren. Great tips. And Victoria, we’ve been talking about the clinical side and CROs and vendors and the sponsors, of course. But what does the qualification of the first digital endpoint as part of the FDA’s Medical Device Development Tools Program mean for the future of clinical research? And do you see any impact also on the regulatory perspectives as well, if you look at this globally?
Victoria Bangieva:
Yeah, mean, know, Sabina, I you’re referring to FDA’s approval of Apple’s APHID -8 care, right, as a medical device development tool. You know, that was a huge and first big step, I would say.
in that process. And honestly, I think we were all very encouraged in the field. I think it truly paves the way for future digital health technologies to gain approval as well. The regulatory aspect is crucial here. Of course, it guides a lot of the clinical research decisions that are being made. And we talked a lot about validation. So anytime that there is that kind of approval from a regulatory body, it certainly increases confidence and that kind of validation of a digital health technology. So my goal, my hope on the play is that it only continues to increase our confidence in D D H T’s more broadly and openness to actually using them in clinical trials. So I think that was again, just to reiterate such an encouraging development in the field and hope to see more of that
Sabine:
Yep, very, good. That’s exactly those are the steps that we need to have taken, don’t we, in order to move this forward. And also, you know, we talk about we’re in we’re in research and and I think again, just going back to and encouraging sponsors to look into take steps because, you know, if they don’t, then who who is going to do this and especially to share the information. again,
Just another big call to action. Any organizations that are interested in having a discussion, know, Victoria and Lauren will be very happy to have conversations with you. So just let’s plug that again. You know, it’s also interesting because, you know, we see and we talk also with lot of VCs. Lauren, you know, we work a lot in that space as well.
What do think about this idea? Should VCs also have their eyes open and looking at what are some of their portfolio companies doing in this space with digital endpoints?
Lauren Alani:
So we’ve found that this is a really good one because we’ve had recently a good number of incredible dialogues with VCs around the use of digital endpoints and their viewpoint of, you know, how they feel about it. And really what we’re seeing is that it’s hugely attractive for them if biotechs are utilizing digital endpoints because of some of the reasons we mentioned earlier, the benefit of potentially reducing the timeline of the clinical trial by increasing the richness of the data and therefore, you know, being able to better demonstrate treatment effect. And that’s becoming a lot more well known and well understood. And it’s certainly an attractive point for VCs when they’re looking at, know, potentially where to invest in next. And it really should help the biotech to stand out or pharma to stand out or at least be neutral.
if it’s a digital endpoint that’s being more broadly used. think what the challenge becomes is the fear of not being left behind as well. So it’s very important to be aware of what digital endpoints are being used within your specific therapeutic area and to make sure that you are considering that impact because we move, yes, we generally move quite slowly as an industry, but we are certainly moving.
Sabine:
Yeah, definitely. And then ultimately, we all know why we’re in this business. It is for patients. And I think that that ultimately, and I think that this is again, such an important initiative that’s happening because ultimately we are looking at ways to improve how patients engage and the ease of which they engage.
in clinical trials. And so I think everything, and I just would really like to pull it back to that because that’s what the output is. Obviously, we’re talking about digital endpoints, but ultimately it does get back to the patient. And have either of you had any feedback on those lines with patients and trials or again, kind of the ease of use and any kind positive feedback around that?
Victoria Bangieva:
Yeah, absolutely. You know, you’re absolutely right there, Sabine, in that it all does come down to the patients and we certainly need to be thinking about them and everything that we do related to clinical research and this work with trying to adopt DHEs more into clinical trials. And you know, a lot of the business benefits that we’ve been talking about actually relates to the patients as well. You know, let’s talk about safety for a minute.
there’s business benefits there, but there’s enormous benefits for the patients as well. You know, if a digital endpoint is able to identify adverse events earlier on or identify any changes in health status earlier on, that can lead to better clinical outcomes, which directly impacts patients. You know, additionally, you mentioned engagement. What we know is that
with patients that are monitor with digital devices often report being more engaged in their healthcare because they receive this immediate feedback and insights in their health conditions. So there’s just tends to be overall enhanced patient engagement. And, and you know, that kind of feeds back then into clinical trials because we know that when patients are more engaged, they tend to adhere better to protocol and treatment guidelines. And that results in, again, then higher quality data and more reliable trial outcomes. So this all loops back to the effectiveness of the trial as well, but that the benefits of DHTs for patients have also been largely looked at and studied and certainly are important as well.
Sabine:
Yeah, absolutely. Thank you so much. I think that there are so many more topics and I know I still have a long list of questions, but I don’t think we’re gonna be able to cover it all today. And potentially, you know, it could be interesting. So let’s maybe look as we get, as you move further into the project as well, maybe we can do a kind of midterm catch up again and see how things are moving along. So we’ll definitely share the progress. Everyone should have a look at the website.
And also what Dime’s doing, it’s amazing work. And we’re really, we’re thrilled to be a part of it and happy that to be working with you and the team, Victoria. So thanks so much. Lauren, thanks for being on the podcast today as well. It was a pleasure. And let’s watch this space. We may be all together again and some time after we start to get some initial data in. So thank you so much.
Victoria Bangieva:
Thank you both.
Lauren Alani:
Yeah, thank you. It’s been such a pleasure. You’ve had such amazing speakers. So it’s great to be invited on Cut the Chat. So thanks for the invite. It’s a real honour.
Victoria Bangieva :
Yeah, same here. Thank you, Sabine.