Episode 14: DCT Pioneer Laura Podolsky explains Decentralized Clinical Trials and what platforms, vendors, and investors need to know
If you’re a DCT platform founder, investor, or agency wanting to support this growing market, you won’t want to miss this conversation with the person who knows more about setting up and managing DCTs than virtually anyone on the planet.
Subscribe on Apple Podcasts, Spotify, Buzzsprout, or follow the podcast on LinkedIn for new episode drops.
In this episode you’ll discover:
Why Decentralized Clinical Trials (DCT) got a boost from the pandemic—and whether this boost is likely to continue
What benefits and drawbacks exist with DCT when compared to traditional clinical trials
How companies which support DCTs can gain access to these trials via the platforms (think: mobile nursing agencies, patient recruitment companies, and mobile labs)
What special privacy considerations are needed in DCT and how companies can adjust their processes to meet those needs
What investors and sponsors look for in a DCT platform during due diligence (including a handy resource)
Learn more from Carrie and Rebecca:
Healthcare insights (monthly email) | Telehealth/Virtual Care Mgmt Update (biweekly LinkedIn update)
Website | Carrie on LinkedIn | Rebecca on LinkedIn | NGL on LinkedIn
“Not only can [DCTs] end up being more convenient, easier, less burdensome for patients, all of that leads to a faster trial…which yields serious financial benefits to the sponsor.”
Learn More Here
Connect with Laura Podolsky on Linkedin
Download the Top 5 Friction Points for DCT Providers here
More tips on how your privacy policies impact key partnerships with vendors and investors here
Read the transcript:
Laura Podolsky (00:00):
There are, as we said, there's some serious benefits and not only can it end up being more convenient, easier, less burdensome for patients, all of that leads to a faster trial. You get the fast, the trial gets recruited faster, it gets completed faster, and hopefully the drug gets to market faster. So that can yield serious financial benefits for the sponsors. And also we hope benefits to the public at large in terms of faster access to needed medicines.
Speaker 2 (00:28):
You're listening to Decoding Healthcare Innovation with Carrie Nixon and Rebecca Gwilt, A podcast for novel and destructive business leaders seeking to transform how we receive and experience healthcare.
Carrie Nixon (00:40):
Hi everyone. I'm Carrie Nixon with the latest episode of Decoding Healthcare Innovation, and I am really pleased to be joined today by Laura Podolsky. She is our newest, latest, and greatest addition to the Nixon Gwilt Law team, and she comes to us from her position as general counsel at Science 37. Laura, welcome to the show, and I know you're going to be talking with us today about decentralized clinical trials, a very hot topic both in the news lately and at the HLTH conference, the health conference that Rebecca and I were at several weeks ago. Welcome, Laura, and will you tell us a little bit about yourself, your background, and about your role at Science 37?
Laura Podolsky (01:24):
Sure. And thank you for having me. So as you mentioned before I joined Nixon Gwilt I was at Science 37 for about six and a half years as the general counsel. I'll talk a little bit about Science 37 in a sec. Before that, I was a healthcare attorney to boutique firm here in la and before that I was working in public health focusing on occupational health and safety. And so I made my way over to law and to healthcare law, and I've been happily over here ever since. So Science 37 operates decentralized clinical trials using a proprietary software platform. And decentralized clinical trials are trials that are oriented around where the patient is rather than where the investigator is. So in a traditional trial, what we might call a brick and mortar trial or a traditional trial, everything happens where the investigator is. So if the investigator is at UCLA Medical Center, all the trial activities take place at UCLA Medical Center.
(02:24):
The patients come in and fill out forms there, they get their blood drawn there, they participate in assessments there and because that's where the investigator is, the challenge with that is that a lot of people don't live near a clinic or brick and mortar center where trials are being conducted and they just can't get there very easily. And so in a decentralized trial, the model is oriented around where the patient is. So the patient stays at home and the trial comes to them through a software application, through visiting nurses, through telemedicine, video conferencing with the investigator and with other trial staff, the investigational medical product or device comes to them where they are. So as much as possible, you're orienting every piece of the trial around where the patient is so that they can stay home. What that does is it enables more people to participate in trials because geography isn't a barrier anymore.
(03:15):
They can participate from anywhere. Hopefully it yields trials where the participant population looks more like the US population, so it's a more representative population of the US or whatever other region of the world the trials being carried out in. And most importantly, not only can more people participate, it's just easier for them. It's less burdensome for patients. They can stay at home, they don't have to reorient their entire lives if they've got other things going on, which basically everybody does, whether that thing is their actual medical condition or family obligations or jobs or school or whatever's going on. So that's what we need when we talk about a decentralized clinical trial or a DCT. And there are gradations, there are some trials that are fully decentralized and there are some trials where components of the trial take place in the patient's home and other pieces take place in a clinic either because that makes more sense or necessarily it just has to, if it's an imaging study or something like this, we have to do that in an imaging center typically.
Carrie Nixon (04:13):
And Laura, was Science 37 one of the path breakers here with decentralized clinical trials?
Laura Podolsky (04:20):
I would say so when Science 37 got started in 2014, very few sponsors had heard of, when I say sponsors, I mean pharmaceutical companies and biotechs. Very few sponsors had heard of DCTs or, and even fewer had engaged in any form of decentralized trial. And at that point in time, there wasn't even a word for it. There wasn't an agreed upon term for this. So sometimes they were called remote trials, sometimes they were called virtual trials. Science 37 came up with the term meta site, and then eventually the industry seemed so settled more on decentralized clinical trial, but it took five or six years to get just to a word for it. So I would say when Science 37 started out, the idea itself was really quite new. It had been piloted in a few different ways, but not really end to end and not using the latest and greatest technology. So I would say yes, Science 37 had a lot of learning to do in the beginning to figure out how do we do these operationally and then what are the legal issues that we have to address in order to carry out these trials in a way that's compliant with all the different regulations and laws that we need to attend to.
Carrie Nixon (05:29):
Well, and then fast forward to the pandemic, and I'm assuming this was one of the only ways that trials could continue was by using a decentralized clinical trial platform. We saw telehealth services get a tremendous boost from the pandemic where people were very hesitant obviously to go into their doctor's office and everyone scrambled to put into place a good telehealth program so that they could see their patients during the pandemic. Were regular trial sites sort of scrambling during the pandemic as well?
Laura Podolsky (06:06):
Yep, absolutely. We saw some trials that were already in progress when the pandemic started having to shift to a decentralized mile model in order to continue. We had some trials that were about to start in a traditional model before the lockdown hit and then had to quickly shift to operating in a fully decentralized model. And then we had some trials that needed to decentralize certain components of it and then had to preserve certain in-person or traditional components as well. So yeah, there was a big uptick in interest and acceptance by necessity in the same way that we saw with telemedicine with DCTs.
Carrie Nixon (06:43):
So our decentralized trial companies, clinical trials, companies experiencing the same sort of questions that have come about around telehealth. So are people saying decentralized clinical trials are here to stay, the genie is out of the bottle. Is this something that's going to continue post pandemic or will drug companies and device companies and researchers go back to business as usual pre pandemic?
Laura Podolsky (07:11):
I mean, think it'll be a mix, frankly. I think the fact that there's been such widespread embrace of telemedicine and not just because you have to, but now it's shifting towards a lot of people just like it. They feel more, it's easier for them. It reduces the anxiety around a doctor's visit if they don't have to actually get there and park and deal with all the kind of logistics of it. And so that's one component is that before the pandemic, before a wider adoption of telemedicine, one concerned sponsors had about the DCT model was whether patients were going to be comfortable participating in a trial through teleconferencing with, or excuse me, through videoconferencing, through an app with home nursing and so on. And the embrace of telemedicine during the pandemic showed us that people are fine with that. They like it in some cases they prefer it. And so that kind of gives a boost to DCTs or I think kind of enhances the foothold of DCTs because it's part of something that's already happening on a wider scale. Generally medicine is moving to the home. This is just part of medicine moving to the home.
Carrie Nixon (08:14):
Yeah, natural. Yeah, natural part of the transition. Exactly. Right. I mean, I can tell you from personal experience, I attended a doctor's appointment in advance of potentially participating in a trial several weeks ago. And the whole experience of getting into this academic medical center and parking in a huge parking lot with construction, it took me 40 minutes to get from the car from pulling into the parking garage into the office. I thought, this is terrible. I don't want to have to do this all the time. And so the notion of a decentralized clinical trial seemed like a no-brainer to me.
Laura Podolsky (08:54):
Yeah, I think it is easier on patients, it makes it easier for them to join the trial in the first place and easier for them to comply with all the requirements that they have to go through during the trial. So it increases participation and it decreases attrition. Those alone are big selling points, and I think during the pandemic DCT operators like Science 37 and others were able to prove out that advantage and also do it across some very rocky terrain. DCT operators faced a lot of the same challenges as any other company. Shortages of supplies, uncertain travel opportunities just general fear and anxiety about having folks come into the home and figuring out what are the best safety protocols. And in the midst of all that difficulty and uncertainty, they were still able to operate these trials. And so I think the combination of telemedicine, the fact that DCTs really are easier for patients and that companies have shown they can actually do it under not ideal circumstances even are all for to the cut in favor of DCTs being with us for a while.
Carrie Nixon (10:04):
Yeah. So those feel like very obvious and unquestionable benefits. Are there drawbacks to decentralized clinical trials?
Laura Podolsky (10:14):
Sure. I mean, I think that first of all, not every trial can be a decentralized clinical trial. It just doesn't work for every single model, and that has to be acknowledged. I think also while decentralized clinical trials are most likely easier for participants, it doesn't mean that they're easier to operationalize. I would say they're harder to operationalize because if you think of it as in a traditional brick and mortar site, everything is under the same roof more or less. And so if you think of all those different participants under that brick and mortar roof, take them and distribute them across the country, potentially across the world, and try to have a seamless participant experience in the trial, that's challenging. We have to make sure the drug gets to the person on time. We have to make sure the nurse gets to the person on time. We have to make sure the person gets home from work on time to receive the drug and be there for the nurse's visit. So there are a lot of logistical challenges involved in bringing the trial to the patient. So all the things that you described, parking, getting into across the construction site, into the office, all of these things that kind of gets absorbed by the DCT operator.
Carrie Nixon (11:22):
Yeah, it's shifting the burden. It's shifting the burden, right?
Laura Podolsky (11:26):
Yeah. So that can be challenging. It can be costly, but as we said, there's some serious benefits and not only can it end up being more convenient, easier, less burdensome for patients, all of that leads to a faster trial. You get the fast trial gets recruited faster, it gets completed faster, and hopefully the drug gets to market faster. So that can yield serious financial benefits for the sponsors and also we hope benefits to the public at large in terms of faster access to needed medicines.
Carrie Nixon (11:59):
Great. So as I understand it, there are some peripheral entities that are involved in supporting decentralized clinical trials like mobile nursing agencies, like patient recruitment companies. Can you talk a little bit about the role of those supporting entities?
Laura Podolsky (12:16):
Sure. So a DCT operator has to decide which parts of the trial it's going to do itself and which parts it might be outsourcing. So in a typical decentralized clinical trial you may have visits to the home that are carried out by phlebotomists or nurses. And so the operator has to decide, are those people going to be our employees or are we going to work with a third party agency, either home health agency or another kind of agency. Similarly, are we going to ship the investigational medical product ourselves, meaning house it and ship it, or are we going to work with a third party vendor to do that? So that's an example. Most DCT operating systems have some kind of software involved. So you have to ask yourselves, are we going to develop that in-house with our own team of developers?
(13:02):
Do we have that capacity or are we going to outsource that? And so there are a lot of potential third parties who are involved in putting together the DCT And that can be challenging of course, just it's a lot of coordination, a lot of contracting, and a lot of decisions about how to distribute risk but it also creates a lot of opportunity. And so if you're a company who's interested in getting involved in DCTs, if you think you have something to contribute to DCTs, either a service or product, what I would say is it's really important to learn about DCTs. And thankfully there are plenty of opportunities to do that now we're seeing so many webinars and articles and such about DCTs. So if you are a company thinking that you could contribute to this space, I would take the time to learn about it and then be able to say, this is what we can do to make this easier. This is our solution, this is how we can improve this process or this part of the patient experience or this part of the investigator experience, quite frankly.
Carrie Nixon (14:00):
Yeah, I think it's really important to study up and know your market and know who you're going to be partnering with.
Laura Podolsky (14:05):
Yeah, I mean, I would say in my experience at Science 37, especially in the very early days, Science 37 was explaining to vendors and to sponsors what a DCT was. So we were trying to engage folks to help us operate these trials, but they had no idea what they were. And that's okay. It was early days, but at this point, there's enough information out there that a vendor who wants to get involved, whether it's a nursing agency, somebody involved in the supply chain in terms of investigational medical product, transportation frankly could be an issue too for nurses and such. They've got a lot of opportunities to learn about it, and I would just encourage that to learn about it and come to the operators with some ideas about how you can help what value you provide.
Carrie Nixon (14:45):
Yeah, that's good advice. So you mentioned just a moment ago mitigating risk. And my suspicion is that there are some interesting privacy considerations around decentralized clinical trials. Can you talk a little bit about those and how companies deal with them?
Laura Podolsky (15:05):
Sure. So there are a couple different ways to look at this. And similar to how many different potential vendors and inputs and kind of little widgets there are involved in operating a DCT, there are that many different types of privacy questions. So there are privacy things related to the software that you're using, making sure that the software application that you're using has been built with a privacy by design mindset. There are a lot of fantastic software engineers out there, but not all of them are familiar with requirements like those under 21 CFR part 11, which sets forth requirements for electronic signatures and electronic records in the clinical trial context. Well, that a fantastic developer just may not have had experience with that or they may not be quite as attuned to state privacy laws or XUS privacy laws. And so making sure that the software that you're using reflects an awareness not just an awareness is compliant with all of these different requirements is huge.
(16:08):
And a lot of those are data privacy requirements. Some of them are security requirements, but those are related. So I'd say thinking about software and the fact that data integrity is, so you've kind of have two things. Data integrity is so important in the clinical trials context and from a privacy perspective, a lot of the data is highly sensitive, absolutely medical information. So we need to make sure that both this privacy and the security of the data are protected as it moves through the software. There's a huge human error potential here. You've got a lot of people who are involved in operating a decentralized trial. This is not a situation where technology replaces people. It's a significant situation where technology connects people, but you still got lots of people, you've got nurses in the field, you've got doctors in all over the place, you've got clinical research coordinators, recruitment folks.
(17:00):
There's just a lot of people who are interacting with a lot of information. And so making sure that everyone top to bottom, east to west is trained and aware of the importance of maintaining patient privacy and other types of privacy I think is really important. Another thing is, again, related to privacy is if you are, one of the great promises of decentralized clinical trials is the ability to recruit from anywhere. That also means you have to comply with the privacy laws of all these different jurisdictions, whether they're states, if you're operating just in the US or whatever geographic entity or political entity you're talking about XUS. If it's a spec specific region of Germany that has specific patient privacy rules and requirements or a whole country. And so that can be challenging just figuring out how to comply with all of those. And some of that involves saying making a calculated risk too sometimes in saying we're going to do our best, but these laws are changing, technology's moving faster than the law, but the law's also changing not always in the direction of technology.
(18:03):
And so how are we going to do our best to meet the best highest standards we can while remaining agile? And so I think it's challenging. I think when I'm advising on data privacy in this context, I think it's helpful to look at the principles underlying the GDPR. So they're like, there's these seven principles that underlie at the GDPR, the lawfulness fairness and transparency, that's one purpose limit limitation data minimization, I won't go through all of them, but there's some good general principles and most privacy laws are trending towards those. That's kind of the north star for privacy. So if you are making it a sincere effort to comply with those, that's good. That's a good start. It's not the end because different countries emphasize different pieces of that differently or have different solutions to those challenges, but it's a start and making sure that everyone in your organization who is interacting with patients and who's designing software and who's also responsible for other operational heavy lifting, making sure that they're attuned to that I think can be really helpful.
Carrie Nixon (19:08):
I mean, the privacy landscape is ever evolving, ever changing, and I'm sure that folks involved with decentralized clinical trials have their hands full in keeping track of it all and just being sure that they are always operating with best practices. So my suspicion is that there are a lot of investors who are very interested in decentralized clinical trial companies these days. I know we've got a lot of investment happening in the digital health space in general, and DCT I think is probably towards the top of the list there. So in your mind, what would an investor be looking for during the due diligence process for investing in a DCT company?
Laura Podolsky (19:53):
So in my experience, there are a number of different things. We just talked about data privacy. That's such a hot topic. Investors are aware of the importance of it, and they want DCT operator to be able to show proactively how they are meeting the highest standards for data privacy. The risks of a data, data breach are so significant. Nobody wants to touch something that if you can't guarantee to the best of your ability that patient privacy is protected, we're not going to have a big leak. It's not going to be a tremendous disaster. So patient data privacy I think is huge, and being able to demonstrate all the different steps that you've taken to ensure data privacy and data security it would be huge one related to that to show how your solution, however you're operating DCTs complies with federal regulations around clinical trials, I think is really important.
(20:46):
The FDA is certainly interested in DCTs and has taken a lot of time to study the options and think about different types of guidance that it might provide, but the regulations themselves have not changed. And so being able to explain to an investor, this is how we comply with FDA requirements and we are not going to get shut down by the FDA because of X, Y, and Z, I think that's an important risk. And if you can mitigate that risk and demonstrate how you do it, that's huge. I think, and this is hard for new companies, I think having a track record and being able to say, we not only do we believe in this, we know it, we think this is a good idea that we've actually practiced, that we've actually run through that. We've actually, we've run this play and to have a track record and some of that, you know, might need some investors who are ready to take, walk that road with you and take that risk with you. But being able to say, yes, we've worked through these different scenarios and we have that experience, I think that's important as well.
Carrie Nixon (21:50):
Yeah, we've been in the trenches. We know what we're dealing with.
Laura Podolsky (21:53):
Yeah.
Carrie Nixon (21:54):
So I mean, Laura, you are a wealth of knowledge in this area for sure, and knowledge and experience. And so I'm interested in your thoughts on who can best benefit from the type of expertise that you have. You are this bank of knowledge and expertise, and this is a really interesting area right now. What kinds of people are most interested in this?
Laura Podolsky (22:24):
I think we're seeing a lot of interest from companies that want to operate decentralized clinical trials. There are more of them coming up and each having a slightly different perspective, but wanting to be say, how can we mitigate the various risks that are involved, the ones that we know and the ones we haven't experienced yet? And so having been in the trenches of this for over six years, I, I've had a lot of experience in that realm and I would love to share that experience. I think also companies, we talked about different types of vendors who might be involved in DCTs and to be, so for folks who are thinking about that this is an area that they want to get involved in and where they want to be offering services or products I think that that's something we can talk about. There are some specific questions that I, you'd want a vendor to be able to answer if you are operating.
(23:13):
And I think that we can provide guidance there. And I think also DCTs provide a lot of opportunity for physician groups to get involved in clinical trials. You don't have to be a clinical trial shop to be involved in decentralized clinical trials because much of the infrastructure is just outside of your building. So you need to have time and willingness to train and to engage, be a PI or a sub- I, a principal investigator or a sub-investigator, but it's not the same as this becoming your full-time job. And so for physicians or physician groups who would like to get more involved in clinical trials, I think DCTs offer them a lot of opportunities too. And I'd love to talk through the different options for folks who are interested in that.
Carrie Nixon (23:58):
That last one is fascinating. I hadn't really thought about that, but it opens up opportunities for physicians who are in private practice rather than being affiliated with a medical center or something like that and for their patients. That's a really neat opportunity. I think patients trust their family physician, their own physician, and if their physician suggests a trial someone who knows them well, they're probably more likely to participate, especially if it's easy. So I understand that you have created actually sort of a checklist to be helpful to decentralized clinical trial companies. That really talks goes through some of the, is it just legal considerations or is it considerations as a whole or a little bit of a mix mix of both?
Laura Podolsky (24:48):
I would say it's a little bit of both, because when we're thinking about what are the legal issues involved in, there are some real basic ones about complying with the federal regulations around clinical trials and state laws around medical information or doctor, doctor-patient relationships and things like that. All the laws and regulations that pertain to the practice of medicine also pertain to physicians who are operating as investigators. The licensing boards don't distinguish between interacting with the patient in the context of a clinical trial and interacting with the patient in the context of a regular clinic visit. And so there's some obvious laws and regulations that we need to attend to, and then there's just a lot of risk. And so thinking about how do we mitigate these risks so we don't have legal issues, which we're going to be probably contractual issues. That's kind of what the checklist is aimed at, helping people think through.
Carrie Nixon (25:46):
All right. So we are going to provide that for our listeners in the notes, the show notes, that's what they're called. And you can look for that there. Laura, I appreciate this conversation so much. You have really been a valuable addition to our firm here, and I appreciate you as a colleague, and I really thank you for joining us.
Laura Podolsky (26:08):
Thank you.
Carrie Nixon (26:08):
All right, everyone. We will see you on the next episode of Decoding Healthcare Innovation. In the meantime, feel free to share our link on social. All right, till next time.