The Health Pulse

GREG HORNE: Hello. Welcome to another episode in a brand new season of the Health Pulse Podcast. I am your host Greg Horne, and in season 2 of our podcast series, we are focused on health innovation and looking to uncover where technology and new approaches will change the world of health and life sciences. As you now know, we are producing this podcast in two formats. So if you've been a traditional audio listener, then I'd like to suggest you switch over to the SAS YouTube channel, where you can see the podcast with video as well.

And of course, we still welcome all your comments. And the email address is still valid-- thehealthpulsepodcast@sas.com. But now, if you are watching through YouTube, you can add comments to the channel, and we always like to see those comments and questions coming in. So for this episode, I am joined by my guest. Craig Lipset. And Craig is an advisor and founder at Clinical Innovation Partners. So Craig, thank you very much for joining us at the Health Pulse Podcast. How are you doing today?

CRAIG LIPSET: Greg, I'm doing great. It's a pleasure to be here with you. Thank you for this opportunity. I've often been reminded that I have a face for radio, and so for your listeners that are audio only, I can assure you, you're missing very little.

GREG HORNE: I always say that. When we talked about changing this to a video podcast, I said my face is perfect for radio. But here we are.

CRAIG LIPSET: Here we are.

GREG HORNE: And Craig, where are you in the world today?

CRAIG LIPSET: Today I'm in New Jersey, about an hour to the left of Manhattan. But it's nice, in that-- well, first of all, the weather is nice outside. It's fall. It's a great time of year here in the Northeast. But it's also a nice time, in that we're starting to get back out, and there are some meetings that are starting to take place again. So it's nice for a lot of reasons right now.

GREG HORNE: Oh, fantastic-- yeah, I'm in Toronto, and the sun is shining. It's a beautiful day here. I'm looking out thinking it may be some cycling time today. So yeah, we'll see. Craig, first of all, let's just chat a bit about yourself. So I said where you are right now, but tell me a little bit about your journey, how you got to where you are, and some of the other things you're involved in today.

CRAIG LIPSET: Thanks, Greg. So a lot of my career is most visible during my time at Pfizer. I was at Pfizer for about a dozen years, and had the opportunity to serve as the head of clinical innovation with a scope that included all of our use of digital in development, our patient engagement strategies, our collaborations with large health systems, and our inclusion in multi-stakeholder initiatives.

And during that time, I had the opportunity to do things like help to launch TransCelerate, to do-- to lead with a lot of our earliest instances using mobile tools and e-consent in our studies, and importantly for today, we had the opportunity to help design and serve on the leadership team for the first fully remote, fully decentralized trial, one that we did at Pfizer over a decade ago.

Prior to Pfizer, I was around the clinical trial technology space for a while. I helped to launch Perceptive Informatics, which was a spin out at the time from Parexel International, a large CRO. And Perceptive was a clinical technology services company that we had spun out from there, and was later reabsorbed, and later spun back out again today as Calyx.

My journey since leaving Pfizer, though, has been really to continue to surround this white space of clinical trial Innovation with eyes on, how do we better identify opportunities? How do we embed them in organizations when they make sense? How do we drive scale and adoption? And I do that today from a few different angles.

As you mentioned earlier, I served as an advisor with a number of organizations, both nonprofit and for-profit entities, whether their groups like the IEEE or the IMI, on their decentralized trial activities. I work with a number of pharma and biotech as well as tech companies and investors around this area. I'm also an educator. I teach at Rutgers University as an assistant professor in health informatics in their program on clinical research management. I teach a course on clinical trial innovation.

I'm an advocate serving as the vice president for the Foundation for Sarcoidosis Research, a disease area of personal interest, because it affects my own lungs, and certainly influences a lot of my thinking as a patient myself. And I'm the vice chair of the MedStar Health Research Institute, a large health system in the mid-Atlantic here in the US covering a very interesting and diverse swath of the country from inner city Baltimore through rural Maryland and back to inner city Washington DC, and working with them on their infrastructure for research studies.

Finally, I helped to co-found and serve as the co-chair for the Decentralized Trials Research Alliance, DTRA, which has grown in the nine months of its existence into a 130-member organization focused exclusively on the global adoption of decentralized research methods. So it sounds like a lot of different things, but it's really all around the same challenge, helping to look at it from a lot of different perspectives with different stakeholders.

GREG HORNE: That's fantastic. But I didn't say it, it does sound like a lot of things. It makes my next question seem kind of a strange thing to ask you really, because when you're not doing all of that, tell me what you like to do out of work-- a hobby, an interest, something that you do in your personal time-- if you have any personal time.

CRAIG LIPSET: I was a music major as an undergrad, and so I will often try to fall back on something that draws back to that past. Over the pandemic, it was trying to pick up some different instruments that I never had the opportunity to pick up earlier in my life. But like many of your listeners, I'm also a parent, and so now that we're getting back out a little bit, I'm still often found either at dance recitals or hockey rinks with the young ones-- who are not quite as young as they once were, but I still love being out with them.

GREG HORNE: That's fantastic. I love music myself. I'm not any good at it. I love to sing at the top of my voice. My kids complain constantly about my singing, but you know what, it makes me feel good, so that's all great.

CRAIG LIPSET: Hey, I remember, when I was at Pfizer, I was stopped in the hallway by a colleague. He was a senior leader there. He looked a little glum. And we were talking about what was bringing him down, and he mentioned, boy, my son is in college, and I think he wants to major in music, and I'm worried about him. What's he going to end up doing for his career?

Now, a fun fact-- I went to a small liberal arts undergraduate school up in Massachusetts. We had maybe eight music majors in that program. Two of them wound up working in clinical research at Pfizer.

GREG HORNE: Wow.

CRAIG LIPSET: I know that might sound a little wonky, but it's really not such a far stretch. The leap from music to science, for those that follow, is hardly a very big jump at all. And what I found in building an innovation team at Pfizer was, unintentionally, I wound up hiring a lot of people with creative arts backgrounds, people that majored in art, in music, in literature. I think that this crossover in terms of mindset actually serves us very well.

GREG HORNE: I think you're right, and I think we can probably fill a whole podcast just talking about why music and mathematics are so intertwined. It's fantastic stuff. You've already alluded to coronavirus and COVID-19, and that really did accelerate, I think, a lot of things-- a lot of digitization and a lot of other health care terms.

But clinical trials is an area we've seen really be moved in this space. So you've already talked a bit about decentralized trials. Tell me a little bit about-- more about, what is a decentralized trial? Why is it important? Why is it potentially the future?

CRAIG LIPSET: So it's funny. I feel like I talk sometimes in two different ways with different audiences about decentralized trials, because on the one hand, it's certainly very exciting. It's an area that has a history that predates the pandemic. And if you click on my Twitter handle-- which is just my name, Craig Lipset-- I've pinned at the top a timeline, a graphic showing the 17-year history of decentralized research pre-pandemic, which dates back to early work at Eli Lilly, early work at Boston University, early work at Pfizer, all of which is some 14 to 17 years old at the time of the pandemic.

And so these methods existed, and a significant amount of investment and experimentation existed prior to the pandemic-- well over $100 million in venture capital prior to the pandemic, including investments from pharma companies, from big tech companies. What we were missing prior to the pandemic wasn't the tools, and it wasn't the regulatory receptivity.

In the US, it was the FDA that led in the Clinical Trials Transformation Initiative, CTTI, in producing recommendations for decentralized trials in 2018. What was missing was adoption in a meaningful way. And certainly, that's what kicked off in earnest during the pandemic, when we had these lockdowns happening around that March, April frame of last year-- and these questions of, how do we maintain continuity for our existing studies?

How do we make sure that patients can have access to their investigational products that they're relying upon? How can we have confidence that their safety is being properly monitored? How can we continue to capture the data on efficacy, the reason why we're doing these studies in the first place? And that's where the rapid adoption of these different decentralized tools started to come to bear.

Now, I mentioned earlier, sometimes I talk in two different ways about decentralized trials. It's cutting edge. It's exciting. It's pro-patient, in terms of improving access, convenience, hopefully diversity and inclusion, as we break away some of the barriers that disproportionately affect some populations from being able to participate. And it provides some resilience and business continuity in a very unpredictable environment. That's one way of positioning decentralized trials.

But the other way is the appreciation that a decentralized trial is still a clinical trial. It's one that's just incorporating some different methods and tools as a strategy to improve access and convenience. And many of those tools are ones that you've been using in clinical research before. Electronic diaries and self-reporting of data is not new. Electronic informed consent are types of tools that many companies have been working to implement for some time.

Home health and visiting nurse-- these aren't new capabilities, but maybe at this scope, in this level, they feel and seem much more new and more ambitious. There are some elements here that are different for us-- our use of local labs and local imaging centers, and figuring out across different studies how to manage the drug supply chain and make sure it reaches to the patient's home.

But my takeaway here is that, for operators in clinical research, in pharma, at CROs, and at sites, these approaches aren't necessarily foreign, and they don't have to be overwhelming. A lot of them are tools that we're already familiar with. And even taking incremental steps forward in the organization is still a step forward.

GREG HORNE: That's really interesting. And it's interesting to hear the regulators kind of like this as well. My experience from way back in clinical trials is-- I was part of the Faculty of Medicine as an undergrad, and we had posters all around saying, come and be part of this trial, and we'll pay you 100 pounds or whatever else. With a decentralized trial, how do you recruit people to do those trials? How do you make sure they stay in the trial? How do you make sure that adherence is managed and regulated, and that the burden on the patient is kept low so that they stay part of this trial, when you don't have them in that centralized environment anymore?

CRAIG LIPSET: So two notes here about that great question that you raised-- first off, I think that there is still a fair amount of question about how enthusiastic regulators are going forward. I think that the FDA has been extremely progressive. And their views on decentralized research predate the pandemic, and have only been reinforced in a lot of their messages. If you pick up the Pandemic Readiness Plan, the prep document that the FDA posted earlier this year, it certainly speaks about decentralized, along with other silver linings from the tragedy of the last year, that the FDA wants to continue and sustain.

Other agencies, like those in Denmark and in Sweden, have also been very open and progressive in wanting to carry these approaches forward. But some regulatory authorities have been much more ambiguous, and I think that that ambiguity creates uncertainty for many study teams looking to operate on a global basis. It's becoming very important for us to address this ambiguity and some of the variability in the views that are emerging.

But you raise such an important point about patient support in these types of studies. When we've seen some survey data, recently out of Europe, patient perspective on hybrid and flexible trials was overwhelmingly positive. And interestingly, patients were also very supportive of using different types of wearables or digital devices. Their concern, though, was very clear-- they don't want to be left alone with unfamiliar technology and without having good robust support around them.

And to me, patient support we have to make sure we're addressing in two different lanes. One is around the technical needs of the patient and the trial. If we're standing up new devices, wearable, sensors, that's fine, but we can't expect conventional study support staff to be able to open up genius bars and help patients to use these tools and devices. My mother doesn't even know her iTunes password. If you want to try and connect a new app on her smartphone, you're going to have your work cut out for you. And we have to have the right technical support to do that.

But to your point earlier, there's also an emotional support element here that people want and they need. Many people like going to a site. They like seeing an investigator and a study coordinator. It makes them feel safe, and protected, and engaged. Just because a trial may be using decentralized methods doesn't mean we are going to be leaving people alone. And we have to make sure that we're making these types of support and engagement, whether through the use of home health, video, community, or otherwise, to make sure that people are supported both technically and emotionally, so that they're able to comply, they're able to stay in the study, and they feel good about doing it.

GREG HORNE: That's really interesting. I want to unpack some of this a little bit, because I think that we need more diversity in our clinical trials. Absolutely, we do. So at the moment-- and from what you talked about there, with technology, and regulators, and the like-- these trials happen in developed nations. So how do we evolve trials globally? How do we make sure that low and middle income countries, places that can really benefit from these trials-- they get access to clinical trial? And how do we get a diverse group of patients involved?

CRAIG LIPSET: Some fabulous points here, because certainly, one of the cornerstones, one of the hopes in decentralized research is that it can be used as a countermeasure to bridge diversity, inclusion, and representation in our studies, both in developed countries as well as in developing regions-- certainly, in developed countries alone, we don't have representation in our studies. And we know, coming out of the COVID pandemic, that there is urgency and capability to bridge that with the right investments.

And for many, whether because of geography, whether because of socioeconomic constraints, whether because of trust, there are real barriers that stand in the way. Decentralized can help to bridge that, if it's done right. Decentralized can exacerbate those problems, if we're ignoring the digital divides that exist in developed regions and elsewhere in the world.

As an example, we need to ensure that we're provisioning devices and connectivity wherever we're planning to use these types of approaches in our studies. We can't make an assumption that people have technology available or save on our budget by expecting to only go with a BYOD, a bring your own device approach, assuming people have the right types of bandwidth and connectivity. Provisioning needs to be a part of our DNA for some time to make sure that we're bridging that divide.

We have to make sure we're not leaving behind some demographics because, as we said earlier, of feeling daunted or overwhelmed by technology, and not having the right support. But also to your point, how do these approaches help us in reaching into developing regions of the world? And I think we're really nascent at that. We've certainly seen over the last few years, pre-pandemic, the opportunities for mobility and the use of devices in developing regions-- in particular, regions where infrastructure for telephones were never strung up with wires, but where some countries moved right into using cellular and right into using more connected-- more modern connectivity.

But it doesn't mean that there is a one-to-one relationship of people having smartphones in their pockets in these regions. Sometimes there is a smartphone for a family or an even larger unit of people sharing a device and some of those regions. Bridging that digital divide and provisioning are going to be cornerstones. But I think it's really early days for us, in terms of decentralized on a global basis.

I think we're still navigating a lot of Asia, a lot of Japan and China. There's been good inroads around a lot of Europe, but still some regulatory ambiguity in some countries. And certainly, the developing region is going to be an important area for us. I think we're seeing some good starting points in Africa as a way to be able to bridge, but it's still very early days.

GREG HORNE: We always like to pick up on a future question as well. So that's really interesting, and it sets us on a trajectory. And we create this podcast to be about health and life sciences, because we see a convergence. We see that the health and life sciences world has become very interconnected. So as you look to the future-- like a year, two years, 10 years, however far out you want to go-- do you really see that convergence continuing?

How do we ensure that convergence is beneficial for all-- for patients and for everybody? And really, what do you see as the future of clinical trial and that role into health care? That's kind of a lot to unpack there, but I just want to get that future view from you.

CRAIG LIPSET: I think there are a few different areas that jump to my mind around that question. One is just around the devices themselves-- that, for a long time, there's been this divide between research-grade devices and consumer-grade devices-- that you might be wearing a Fitbit, but I need you to wear a research grade actigraphy device for this clinical trial.

And in the past, we did, because a lot of the consumer-grade devices were processing a lot of the data on them. They were reducing a lot of the fidelity. They were just really in the business of rendering-- remember the early Fitbits? It was like a Tamagotchi. It was like a flower blooming. And the research-grade devices-- we wanted-- I won't call it raw, but far less processed data to be able to run different smart algorithms off of.

And there's certainly been a convergence there. And leaders in that field like Don Jones at out at Scripps had predicted this years ago, as had many others-- as both the cost of the technology and side becomes more accessible, that the consumer and the research-grade devices today look much more similar. And it's really now a question of, can we get the right data off of the device, if it's proprietary or locked down?

But the really exciting part to your question is this thread that so many in the community have called clinical research as a care option. How do we enable it so that every point of care, every interaction that a patient is having with their provider, where they're weighing different care options-- that clinical research could be right there with the other options that are available?

And what we're starting to see is, as decentralized research methods get more and more adoption, there are-- there's a new economy that's starting to emerge of other capabilities that we couldn't have seen three or four years ago. And I'll share an example that's standing out to me. Decentralized trials are creating new ways for us to engage with the non-investigator physician in local communities in ways that we've never been able to prior to the pandemic.

As we're using video, as we're using mobile nursing and other capabilities away from a traditional site, rather than that always being in the home, how might some of that start to take place in the trusted and convenient location of a patient's own doctor's office? And in doing so, do we now have a new way to engage with local physicians in the community that's better than the two choices that we've always brought to them in the past?

The two choices of the past were come by an investigator in my study or send your patients to an investigator in my study. And neither of those were very appealing for most providers. Now we're starting to see an option three that's being catalyzed by the adoption of remote tools. And how might that start to democratize access to research so that it no longer is dependent on the serendipity that you happen to go to a doctor who happens to be an investigator in the trial that happens to be right for you? But all of a sudden, as you're envisioning, we can see this convergence of research and health care, because we've created new ways for physicians to engage in research without the heavy lift and burden of being an investigator.

GREG HORNE: Wow, that's fantastic. And Craig, thank you very much for those insights and the discussion today. It's been really, really interesting. And I think our audience will find it so too. So yeah, now it's over to you, the audience. Please email your questions and comments to thehealthpulsepodcast@sas.com. Add them on the YouTube channel, those comments there, all very well-received.

And as I always say, these are really shaping our guests and the way we take the podcast forward, so please keep those comments coming. Particularly on this episode, I'd like to hear your thoughts about that convergence piece. How do we get more primary care physicians involved in the role of clinical trials, and how do we get it to more patients? Please keep those comments and questions coming through.

Also, please remember to subscribe, either through your podcast aggregator or through the SAS YouTube channel. So all that's left for me to say is, I've been your host, Greg Horne. Thank you for joining us today. I look forward to bringing you another episode of the Health Pulse Podcast very soon. Thank you, and goodbye.