Episode 24: The Rules Have Changed: Decentralized Clinical Trials for Drugs

In this episode, Partner and Co-Chair of the Firm’s Health Care Practice Group Kyle Faget, and Partner Monica Chmielewski are joined by Jodi Akin, Founder and CEO of Hawthorne Effect. Hawthorne Effect has embraced the decentralized clinical trial model and is dedicated to enriching the quality, experience, diversity, and access to clinical trials for patients, providers, and sponsors. With Jodi, we explore the newly released FDA Guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, and how Hawthorne Effect was positioned for this guidance and what steps it will take to adapt its practices. We also explore the unique opportunities afforded by conducting decentralized clinical trials.

Jodi Akin is the Founder and CEO of Hawthorne Effect. She is a health care executive, leader, innovator, and advisor with more than 25 years of experience in clinical development, scientific and regulatory strategy, management and medtech market development. She is passionate about efficiencies in innovation and stakeholder experiences- most importantly, the patient. Jodi led seminal global clinical trials and approvals of transcatheter heart valve therapy at Edwards Lifesciences, LLC through 2014. She is a serial entrepreneur, most recently founding Hawthorne Effect, Inc., an innovative platform for revolutionizing patient follow-up.

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Please note that the interview copy below is not verbatim. We do our best to provide you with a summary of what is covered during the show. Thank you for your consideration, and enjoy the show!

Kyle Faget

Thank you so much for the introduction, Judy. Hi, welcome everybody. I’m Kyle Faget. I’m the co-chair of the National Healthcare Practice Group at Foley & Lardner, and I’m a partner in our Boston office. I’m here with my colleague, Monica Chmielewski and the founder and CEO of Hawthorne Effect, Jodi Akin. We’re going to talk today about decentralized clinical trials, FDA’s recent guidance about the same and about Hawthorne Effect and how Hawthorne Effect is adjusting to FDA’s most recent guidance. And start by letting Jodi talk about Hawthorne Effect and what Hawthorne Effect is bringing to the market.

Jodi Akin

Thank you, Kyle. Hawthorne Effect was founded in 2015 and inspired by, at that point, 25 or more years of designing, conducting clinical trials globally for breakthrough therapies that required really high-level bodies of evidence to demonstrate safety and effectiveness for therapies that may have been unprecedented or have a really high bar of evidence generation. And so, the idea back then before I think DCT was a concept was to be able to make clinical trials more accessible and more high quality and complete for patients to participate in beyond the brick and mortar of academic or traditional clinical institutions.

So, the twofold mission was, number one, to make it easier for patients to access clinical trials and participate in them because of the burdens of participation, but also at the same time to ensure a very high quality and consistency of data that is time-sensitive and needs to be measured in quite accurate ways. So, the platform is a combination, it’s a technology enabled service. The tech stack is designed to orchestrate and enable clinicians that we call Heroes to meet patients on their terms, to carry them through clinical trial journey from screening to longitudinal follow up and tie that journey to investigators and be able to collect and deliver data in a high-quality way in and in accordance with regulatory guidelines.

Monica Chmielewski

Right. Well, thank you, Jodi, that’s really informative. Hawthorne Effect obviously is well-poised and has been working in this space, and so I think the FDA’s draft guidance on decentralized clinical trials is completely in your wheelhouse, and so we really appreciate you being willing to speak with us today about this. As you know, the draft guidance was issued earlier this month, in the month of May, by the FDA. It gives some tips on the conduct, the structure of decentralized clinical trials, looking at the design, what can be conducted remotely, what needs to potentially be in-person, looks at the role of digital health technologies, the role the sponsor and the role of the investigator focuses on the product that’s the focus of the trial, and it really contemplates that local healthcare professionals can, when appropriate, perform certain clinical trial activities provided however that they’re typical in terms of the scope of practice and don’t require detailed knowledge of the investigational product, whether it’s an investigational device under an IDE or an investigational drug.

We need to make sure the guidance states that sub-investigators are trained on required procedures that require detailed knowledge of the protocol, and it does make a distinction between use of local healthcare providers that don’t need to have detailed knowledge of the protocol versus trained sub-investigators. So, there’s a number of requirements that the guidance discusses in terms of use of these local HCPs. Jodi, for Hawthorne, how does your model, and there’s a lot there and there’s a lot that we can talk about in a package, but how do you see Hawthorne’s model as being set up to accommodate this structure, this decentralized clinical structure and these requirements that the FDA has touched upon in their draft guidance?

Jodi Akin

Thank you. So, I think that almost every single aspect that’s now contemplated the guidance was contemplated in the architecture and the design and structure, both of our platform and how we created this distributed network of healthcare professionals that could be enabled to utilize their scopes of practice, their licensure, and then further training through the platform to meet the goals as outlined in GCP. So I’ll break it down a little bit, and like the guidance, there is a lot to the platform. So first starting with the, I would say, investigators, sub-investigators and delegates, so beyond those investigators, who else on the traditional clinical research team are conducting activities related to the investigator’s oversight? So that was the first piece we contemplated that there needed to be a way to curate and then invite medical professionals of all practice scopes because clinical trials require more than blood draws or more than a patient reported outcomes, we wanted to be able to accommodate even the most, I would say, complex types of assessments that would need to be conducted.

And so, to be able to curate, invite to a platform, have an application, our Heroes be able to be credentialed, verifying their scopes of practice, their licensures, then further once they’re what we call onboarded to the platform, be invited into a specialized learning management system that holds a number of training courses, a full complement GCP training, and then all other kinds of certifications and courses related in general to the conduct of clinical trials, how to assess and report adverse events, and so on and so forth.

So, all that was contemplated on the Heroes side so that we could always verify, certify, train, and continuously train and monitor the medical professionals themselves, all ticked and tied to the idea that an investigator who is overarchingly responsible under a 1572 can have an oversight of these professionals via this mechanism. So that’s how we handled, again, from the genesis of architecting the platform, that we would be able to assert that the medical professionals, while they might not be experts in the actual protocol, would be able to conduct their roles and responsibilities very specifically and that we can certify that. So that’s the investigator and Hero part.

Kyle Faget

Thank you, Jodi. So another thing that the guidance discusses, and I imagine this really is an issue. When you’re in a brick and mortar context, you might have one research coordinator and a specific team of individuals that are conducting procedures called for and a protocol. So it’s the same team, same individuals doing and carrying out a protocol, and so imagine you have some quality control there. In the context of a decentralized clinical trial, though you might have numerous local HCPs or sub-investigators performing the same type of procedure, but different individuals. And so, FDA commented on this idea of quality control when you have so many different providers conducting what should be ultimately the same procedure, but there might be some variation because there’s so many other individuals. And so, FDA was concerned about that quality control piece both from the standpoint of conducting procedures and then even data that data input is coming from so many different places. How is Hawthorne Effect addressing this idea of numerous inputs, numerous providers, and addressing quality control in that context?

Jodi Akin

Yeah, a great question, and again, that was ground zero in my mind. Again, I come from a couple of decades of ringing my hands in not only the design and execution of clinical trials, but to be able to, at the end of the day, deliver data packages so that the FDA and its advisors could interpret that data. And so, that comes with even outside of a decentralized model, one always needs to worry about if a six-minute walk test is being conducted not only consistently within an institution, but across all 50 or 100 institutions in the trial. So that for me was sort of the fundamental, it had to be a necessity that we created an ecosystem that would assure that level of quality and I hope someday could be viewed as even higher than we expect from institutions. Then I’ll break it down.

So the next part of the platform, I talked about credentialing and certifying all that. So, the sort of underpinning of our platform is we took the concept of the study visit table and what assessments would need to be conducted throughout the trial. And for each assessment, assign instructions digitally with what is the assessment, for example, a six-minute walk test or NIH stroke scales test, and so on and so forth? Who ought to be doing it from a credentialing point of view? What is the methodology of conducting that assessment? What equipment might be associated with it? What are the data points be collected? And that’s coded into our platform so that there’s actually a training course for each and every one of those elements, and there’s also consistency of instrumentation. So I would argue we can even take it up a notch in terms of conformity in data collection.

So for example, we use the same EKG regardless of trial, regardless of state, regardless of other study specifics, or we will identify again which specific instrumentation that is vetted and verified. Again, from the very framework, the very foundation of the platform, job one had to be able to create a reliability and conformity of assessments over time. So that’s how it’s built and constructed. The second thing to talk about is just our methodology, what we call our playbook. So most trials or all trials have a manual of operations. And again, I’m delighted about the guidance document because all these things are now laid out, but we always run trials with manuals of operations that outline things like how data is collected and what level of monitoring is done. So we do the same on a study by study basis.

There is a playbook, we call it the HEMOP, the Hawthorne Effect Manual Operations, and that will, at a study specific level, outline what are the assessments, what is the equipment plan, what is the Hero criteria that we outline, what is the training plan, so on and so forth. And that’s set at the beginning of the study, it’s shared with the investigators and the sponsors, everyone agrees that that’s the plan. And then the Heroes that are invited into those projects are trained accordingly. So I think both from a digital technology point of view and from our sort of playbook, our process of procedures, we address quality in a very deep way.

Monica Chmielewski

Tying into the quality concept, and the guidance is also information regarding safety monitoring plans. The FDA has rightfully so identified that we need to make sure that even in the use of these decentralized clinical trials and these technologies that sponsors build into their protocols, some type of a safety monitoring plan that takes into account the decentralized nature of the clinical trial and needs to describe how participants are expected to respond to and to report adverse events, including participants specifically, where they can seek medical assistance, where to seek follow up care. The FDA is tasking sponsors to make sure that the safety monitoring plan will include information for investigators, how adverse events can be reported, the safety monitoring plan, the FDA deposit should describe the type of information that should be collected and how it’s going to be used and monitored, it should describe what actions investigators and participants should take in relation to safety issues, adverse events.

And at a high level, it also describes, okay, how are adverse events going to be identified and managed, including adverse events that would require some in-person attention when visits are virtual. If there’s some type of adverse event or harm to the participant that requires some hands-on attention, how is that addressed when you’re using these technologies, when the interactions between the investigator or the Heroes or study staff are actually via virtual means? So, in any of the recent studies that you’ve been conducting, have you seen provisions accounting for these safety monitoring plans, these adverse events in the protocols, and do and how are you training your Heroes on this currently with respect to your studies?

Jodi Akin

Yeah, this is an extremely important topic, and I will say that probably the aspect of decentralized clinical trials, meaning either conducting visits virtually or even physically within homes or outside of the traditional sites, how we address that is I think evolving, to be honest. But let me start from the beginning. So the very fundamentals of adverse event reporting, this part I think is not different than tradition in that, for example, we train our Heroes again in all aspects of GCP, including adverse events, why we’re looking for them, what we’re looking for, and then how to report those adverse events. So we have a mechanism through our platform that when a Hero is conducting a visit, whether it’s virtual or in-person, we do a line in share of complex studies where they’re in-person visits, and often by the way, with advanced practitioners doing these visits.

If an adverse event is identified in that setting, then a form is completed, and we have mechanisms to notify the investigator immediately in a way that they could respond to what the physical or whatever clinical findings have been, and then weigh in from that regulatory point of view on relatedness and anticipated and seriousness and those kinds of things that are part of the rigor of GCP. So, ticked and tied in a process for that. I think what’s new to be contemplated that frankly we’ve been on the forefront of really pioneering procedures about how to think about this is one of the wonderful benefits of decentralized clinical trials, and one of the pointed reasons for doing them is that we can invite patients from rural or communities that are outlying geographically and otherwise these brick and mortar institutions or ivory towers. But what that means too is that we want to make sure that the information that’s going back to the investigator is also flowing back to their own providers and those kinds of things.

So I think that part is really evolving, and I’m very excited about this because my broadest vision of all of what we’re endeavoring is to, I would say, narrow the gap between the silos of clinical trials and clinical care. So this is sort of bringing forward the idea of how to ensure that data that’s collected as part of a clinical trial protocol is getting to the providers and that the patients are informed about what they need to follow up. And I think this is an area that is still evolving and is an exciting area to endeavor in terms of linking medical records and things like that.

Kyle Faget

Thank you, Jodi. One piece in the guidance addresses the need for there to be a physical location where the clinical trial related records will reside, and that’s obviously so FDA can come and inspect. But another piece of it that I thought was odd, and we see this a lot in telemedicine related guidance, laws, regulations, these oddities where I wonder if FDA thought this through 100% or what they were envisioning, and maybe they’ll clarify this in the final guidance. But there’s an aspect of this as well where FDA expects that this central physical location where records may be inspected, in addition to that, personnel need to be available to be interviewed as well. And it’s unclear to me, and I don’t know if you read this differently. Does that mean that all of the Heroes need to be present and available at this one physical location because that pretty much seems quite counter to the idea of decentralized clinical trials, or is it just that these clinicians or Heroes need to be made available telephonically or otherwise? How did you read that requirement and what is Hawthorne Effect doing to try and meet that requirement?

Jodi Akin

Yeah, I didn’t read that quite the same way, and I’m definitely going to be keen to doing the seminars and being involved in the evolution of this. I took that to be a little bit to the traditional, meaning that if there are inspections like BIMO inspections that happen, they typically will happen as you know, either at the sponsor or manufacturer level. And then at the site level, one would expect physical or inspection visits where the type of personnel that are interviewed are the investigators, the sub Is, the coordinators, and then at the sponsor level, the subject matter areas relevant to the part of the audit that’s being conducted. And so, I think with that in mind, it’s not dissimilar for how we conduct ourselves, we support our sites if they’re having a physical BIMO audit, then we’re very connected to the investigators in the sites and prepare together and make sure that the sites have all the information that’s relevant.

So for example, if a Hawthorne Hero is conducting visits for patients that they’ve enrolled, then all the documentation around the Hero, their certifications, that they’re on the delegation of authority or their information is available, and then all the data related to the visits, that’s all available physically or definitely virtually. If they want to download and print and put into binders and have them physically able to be inspected, they can do that. I didn’t interpret that each individual Hero would need to be interviewed no more than a phlebotomist would be interviewed who did a blood draw for a study visit or an echo sonographer in a hospital would never be interviewed about an echo.

So I think it’s the study personnel that are more related to, I would say, the oversight of the trial. And then the physicality, yeah, I’m smiling because we’ve all worked really hard to move away from paper, and frankly in our early days we have both physical sources and eSources. The physical sources are becoming antiquated, but the eSources are source of record, so if needed, they could be printed and provided in traditional binders and things like that. But I think we should definitely contemplate these more efficient means, but certainly Hawthorne Effect would be prepared to host a physical visit and/or to support those types of interviews.

Monica Chmielewski

Yeah, and you raised a good point about interpretation of this and be willing to attend the seminars. I think that as we know the FDA has put out, and we can provide comments on this, and there will be various seminars and webinars that the FDA is hosting, we can seek further clarity and guidance. And another issue, in the guidance that we may be looking to expand upon and seek additional guidance from the FDA is in relation to the intersection between the regulation of clinical research, as we’re aware under the FDA regulations and the common rule, but also now the use of telemedicine and telemedicine technologies, which we know is regulated largely at a state level. And the guidance specifically states that it’s the sponsors, but also the investigators’ responsibility to ensure that any remote clinical trial visits that are conducted using telemedicine, telehealth, one of these digital technologies complies with applicable laws governing telehealth in the relevant US states or territories for other countries as applicable.

And I think one of the challenges that we’ve seen is that telemedicine, again, is largely state regulated. So states will have their own individual and unique, sometimes consistent laws regarding licensure. So if you have a principal investigator who’s located in Illinois, but providing visits or interacting with a study subject, say in Montana, where does that physician need to be licensed to be able to perform those study visits? There’s telemedicine regulations governing informed consent. So if you’re going to be interacting with a patient using these digital technologies, certain states have additional informed consent requirements that could potentially be required to be layered over the traditional informed consent requirements we would see for a normal research study.

And part of this goes to the question of, and raises the issue of, is clinical trial activity, could that be considered to be the practice of medicine? That’s, again, figuring these telemedicine standards. For example, in Texas, we know that their practice of medicine definition specifically includes research analysts and other states are silent or it doesn’t contemplate. I think this is going to be an evolving and continuing issue, and I’m interested, as you are in this space and been acting in this space, how have you managed this issue so far? Any tips?

Jodi Akin

Yeah. Well, this is not my first, I would say, career or path in something that is completely change management from status quo in healthcare. What’s different from the usual or the standard of practice and what might we contemplate as risks the plan and so on and so forth? What’s going to unfold? And one thing I’ve learned in my career, especially a lot of medical technology, and we see this in the world by the way at large, which is that regulations are kind of a trailing kind of thing. Usually you’re foraying into new technology, a new world and regulations have not caught up with that yet. So I kind of surmised that that was going to happen, that’s how I was introduced to Foley. And working closely with Kyle, I thought about that early on and said, “Okay, how might this be considered?” I did not assume that clinical research would necessarily be at that moment considered practice of medicine and took a point of view of this is protocol, it’s under the oversight of an investigator.

And in the early days, particularly of Hawthorne Effect, we were careful that the studies that we conducted and the activities that we did, the assessments that we were conducting were for the sake of collecting data and not for interpretation or for practice of medicine. So we took sort of a point of view, but we also took a point of view that things will change over time. And in my, again, long career, they tend to change for the conservative. And so, I kind of anticipated that, as time went by, we should presume that whether the trials become more where you’re delivering drugs, experimental or investigational drugs or doing procedures and things like that, that fall under practice of medicine, that we should be prepared for that. And so, we kind of started to pave that road early on to be anticipating this day would be coming.

So that’s sort of anticipated, there would be unknown regulatory, guidance or even legal constructs and just trying to stay ahead of the curve that way as I think we have done. Having said all of that, it is insane the state by state requirements, because we credential all of our Heroes, we make sure they’re licensed where they’re supposed to be licensed, let alone the practice of medicine just to make sure because we can have Heroes that can practice in multi-state and things like that. And it’s really the idea of having compact licensures and oversight of it, our system is just so a giant quagmire of state versus national rules, and it’s a lot to manage, it’s a lot to keep up with, and I question the logic of that, and I would love to see more change coming in that, not just about clinical trials, but how we can have cross state licensures and other ways of managing this process.

Kyle Faget

Jodi, I think you joined many in wanting to have a national standard here, both for licensure and telehealth practice standards, it’s very complicated. And from my point of view, there’s so many upsides to the decentralized model, up to and including as you’ve already addressed, all of a sudden you can get patient participation in trials in rural geographies where once those patients would never considered being part of a clinical trial because it just the access burden was just way too high, but I also think that this patchwork of legislation and regulation, very difficult for-

Jodi Akin

It is, and think about…

Kyle Faget

… entrants into this space.

Jodi Akin

Yeah. I think that wholesale really needs to be looked at in general. And think about where technology’s taken us, so this is something that really fascinated me in endeavoring this, which is I had this thought that as technology matures, so let’s take an example, I mentioned a 12-lead EKG. Well, in my early days of practice, you needed to understand Einthoven’s theory of human physics and physiology where to place leads. And you had to be a subject matter expert to actually do a 12-lead EKG, where should I put the leads, and how do I run the machine and all that kind of stuff. Well, today, use sensors or we use an elegant 12-lead EKG that’s a band around the chest and accurately collects that. So, as it’s technology levels the field in terms of who can conduct certain assessments, that’s another whole point.

So, it’s something to think about that that should lead us more to national licensure, and we try to cover those things with not only what are scopes of practice and what’s appropriate, but what are the most elegant ways of assessing patients and conducting clinical assessments, data collection, etc. That’s actually raising the bar on conformity. So rather to get mired down in, I have a nurse practitioner in Montana, is it okay for her or him to take that call in Colorado when they’re going to conduct this test the same way with the same skill and the same type of thing? So I think that it all does seem quite silly and it’s extremely complicated.

Kyle Faget

But I think it sort of puts in sharp focus, this juxtaposition that Monica raised about practice of medicine versus a protocolized, we’re just acting out the elements of a protocol. And I think FDA has traditionally, and for good reason, taken the view that this isn’t traditional clinical care, you can see it as an element required informed consent that the trial participant needs to understand and appreciate that this is not the same as traditional medical care, this is investigational, and that’s a really important piece that needs to be addressed as you’re going through the informed consent process. But then on the other hand, as FDA acknowledged in this guidance, there are state laws about practice and practice standards, particularly for telemedicine, and as Monica suggested in the state of Texas, it’s very clear that clinical research is considered the practice of medicine.

So then you have this tension where FDA is saying, “Okay, look, you know what, if you’re going to practice telemedicine in the state of Montana, X element in the protocol may require, or you may want there to be a virtual visit there, but under those practice standards, that may need to be real-time audio, video telecommunication for that type of procedure.” Whereas if you went into the state of Florida, it might be perfectly fine to have asynchronous telemedicine used as the modality. And so, there’s got to be a lot of adjustment and a lot of thought. And FDA actually stated in the guidance that the protocol should specify what should be virtual and what should be in-person.

And what’s interesting to me about that tension is that a lot of state telemedicine laws leave it to the physician or the clinician’s discretion to determine whether or not a virtual visit can be conducted and meet the standard of care, which again, these are all practice of medicine or practice of a professional licensure decision making, but the sponsor is going to have to, at least under this guidance, dictate at the outset, this is going to be virtual, this is going to be in-person. And sometimes that might be, and it’s going to require a lot of diligence on the sponsor’s part to make sure that they’re not putting something in the protocol and saying, “Hey, this should be virtual,” when in fact, in any given geography, that might not be the right approach, and then the clinician ultimately is supposed to be the one that has jurisdiction to make that decision what’s appropriate for in-person and what’s appropriate for virtual.

So, it’s an ongoing tension there. But importantly for the purposes of Hawthorne Effect, have you seen any clinicians bulk at anything that’s contemplated to be virtual and/or if you haven’t, or has it just been so clear this would meet the standard of care? We’re so far away from the line of a question about what should be in-person or virtual that it hasn’t come up, and then if it does come up, what are your thoughts about this, in this tension?

Jodi Akin

Well, yeah, there’s a lot packed in there. [inaudible 00:33:17]

Kyle Faget

Yeah, sorry. Sorry.

Jodi Akin

There’s a lot in there. I want to end up with the sponsor and I don’t want to forget to do that, but for Hawthorne Effect, because we started with what I call complex trials, trials where the study visit table contemplates 15 different assessments in one visit, an echocardiogram, a blood draw, and a neurologic exam. And because of that, the nature of most of the trials that we support, we’ve done full virtual trials, we’ve done telepresence trials, but our real wheelhouse is in these complex Phase 3 trials, Phase 2 trials where really the lowest bar of scope of practice to conduct all of those assessments is sort of the level of a nurse practitioner or even an MD. And because of that, we do a lot of physical visits and we do them in a very rigorous and choreographed way.

So frankly, we haven’t needed to, or the sponsored hasn’t in those types of protocols substituted telepresence for those things because there’s just other data collection, I had one physician tell me apps can’t draw blood, so if there’s a blood draw on a study visit table, then it still requires a physical visit. So that’s sort of a bit more of our wheelhouse. But you tapped into something about the sponsors and the protocols and what they’re writing, and it triggered something back to being the sponsor days where we would write things into protocols, by the way, that compensated or addressed the limitations of patients having to go to brick and mortar. So for example, we used to exclude patients simply if they live 50 miles or 100 miles from a site because we knew that that would compromise their compliance over time, or we would see that sometimes sites would enroll patients knowing the patients aren’t going to come back, but would have call up their local physician and say, “Did you happen to get a blood draw or this or that,” and use that as clinical trial data.

So we would write things into the protocol like the patient has to physically come back here for their visits. That was constructed for compliance, but those vestiges are still in protocols, and we do have to teach and encourage sponsors to really construct their protocols from scratch. I know that’s hard to do, a lot of people will rinse and repeat and borrow an old protocol and sort of just adjust them. So I think that’s the hardest part of the DCT movement is reticence on the sponsors part for change. Frankly, I think the DCT guidance is, again, so encouraging to me in general because FDA embraces that this can be a methodology for capturing diversity and accessibility and even collecting more and interesting data and trials. And so we need to together make the… I’m more concerned about making the guidance friendly to sponsors and to educate sponsors about how they can write their protocols to your point, and how do we address for that? When do they choose a telepresence assessment over not?

And I hope what ends up happening here is that we can be more creative about protocols, and what is it we’re trying to measure, and why are we trying to measure it, and what is the most productive way to do it? So I think this is open up new thinking. If anything, I tend to be an optimist, but that’s sort of how I’m thinking about it. And I am, again, thrilled to use this guidance to have conversations with sponsors now and say, “See, there’s a footprint for this. There’s a roadmap for this. There’s encouragement to do it. Let’s sit down and write that protocol in a very forward-thinking way rather than get stuck in some old ways.”

Monica Chmielewski

And I think that actually nicely leads into, and that you’ve already started answering in some ways I think is one of the more difficult questions, but exciting at the same time in that as we move forward, and I think everybody’s in agreement that the hope is there will be more use of decentralized clinical trials going forward. I mean, the FDA and the guidance stresses, obviously, what they see the benefits of these being, as you just touched upon, greater access to clinical trials, diversity, inclusion. What else do you see as potentially being in the future, the greatest opportunities, but then also potentially the largest hurdles for the DTC space?

Jodi Akin

I think the greatest opportunities is it almost will be a new world. I mean, I think my goal, my vision, my dream is that we’re arching into a place where we create better real-world evidence through the ability to reach patients in their natural habitats, in their comfort zones, and be able to do real-time or point in time collection of assessments and data, and have that data be delivered directly into their records so that when we’re doing data scraping and all that kind of stuff, we have real, real-world evidence. So I think bringing clinical research right to the communities and utilizing research naive clinics, even retail health environments to invite and encourage patients to participate. I think that’s the ultimate opportunity here.

I think the hurdles, there might be some reticence, I would think, again, at certain sponsor levels, because before FDA weighs in on the things, then they have been a little bit more unclear about how to proceed. So I think this could help break open a more broad mindset to DCT. Again, that’s my experience, and we have a lot of experience with investigators who are not reluctant, site staff might be a little bit reluctant, but definitely sponsors are concerned, if it’s not, I would say black and white about what the roadmap is in terms of FDA’s oversight.

Kyle Faget

And one of the things, Jodi, that you’ve talked about directly and indirectly, to me, one of the biggest opportunities of decentralized clinical trials is increasing diversity and participation in clinical trials, like this has been talked about for years, that X percentage of the trials, trial participants have historically been white men, and that only gives you one snapshot of what a product will do in exactly that cohort, and FDA has been stressing for years that clinical trials need to be diversified. I mean, this is the mandate, and to me, this is the obvious path forward. When you can actually meet people where they are, you have the opportunity to blow the doors off of that traditional model, and to me, this is the answer to diversification.

Jodi Akin

This is the end goal. I’m going to jump in there just because I’m super excited about this. I agree with you, Kyle, that it’s been at least 20 years of my career, we’ve been writing into protocols, there’s been first guidance, then it’s codified into law, up until the 21st Century Cure Act, I mean, it’s everywhere. You can’t get NIH funding without making commitment or showing that you’re moving the needle, and still the needle has not moved up until very recently. I mean, it’s shocking that you’re still getting these very low percentages of diversity, but the reason why is because of this accessibility problem. So you could write it into law, you could write it in the protocol all day long, but if a patient can’t go from their six flight walkup in the middle of winter in Detroit to their research hospital, it’s not going to change their participation.

And that’s why I’m so excited about Hawthorne Effect because that was exactly what we bring it to them, bring it to their homes, bring it to their local environments, and that does enable it. And so, I have a sort of exciting thing to share where one of the trials that Hawthorne Effect is it is not an FDA trial, it’s a prevalence study, but it’s a beautiful example that we have a virtual site of record, one brick and mortar, one site, not hundreds of sites, but we’re enrolling patients from Hawaii to Maine and all four corners and into communities. I think we’re at 47 states now, have enrolled participants into this study in kind of a rapid fashion. But recently when we looked at the demographics, because we were able to approach broadly, we’ve sort of cracked the code with 15% African American participating versus usually the under 5% represented in trials, whereas our population is 13% African American, same for Asian population. So we’re now starting to see this representation come through and it’s super-duper exciting.

Kyle Faget

That’s amazing. I love that. Well, thank you, Jodi, so much for your time. Thank you, Monica, for helping out here and participating as well. Is there anything else, Jodi, that you think our listeners should know about before we let them go?

Jodi Akin

Yeah. No, I think we should all have a voice, I think we should applaud the FDA for coming out with this guidance. It read very, I think, encouraging to me, and I’m definitely encouraged because what we contemplated, we’re all in the right direction together and the underpinnings, and I’m happy to share that with sponsors and colleagues about investigators, etc., how to skate to where the puck is going, and it is decentralized, and I think it is here to stay. This is, by the way, an enhancement to traditional sites, so this is, I don’t think a threat at all to the traditional brick and mortar sites, and we should all embrace where the Earth is going, for sure.

Kyle Faget

Yeah, I couldn’t agree more. Well, we’re really looking forward to watching Hawthorne Effect grow and flourish. Obviously you were pioneering in this space, and it’s just really exciting and a really exciting time. So thank you so much for spending some time to talk to us today and inform our listeners about what Hawthorne Effect is doing and kind of what’s going on in the world. So thank you.

Jodi Akin

Thank you. Thank you, Kyle.

Kyle Faget

And now back to you, Judy.