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Digital Therapeutics for Substance Use Disorders: ...
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Thank you very much, Jen. Good afternoon, everyone. I'm Will Ackland, Director of the Behavioral Therapies Development Program in the Division of Therapeutics at the National Institute on Drug Abuse. I'm delighted to present today's webinar on digital therapeutics for substance use disorders, priorities, clinical priorities, as well as clinical validation. This is an exciting area of science, and I will posit during my presentation that digital therapeutics may offer a complete model of care, how treatment packages benefit patients by delivering interventions with fidelity, as well as state-of-the-art practices in a seamless delivery platform. I do not have any disclosures to report, and the overarching goal of PCSS is to train health care professionals in evidence-based practices for the prevention and treatment of opiate use disorders, particularly in prescribing medications, as well as prevention and treatment of substance use disorders. At the conclusion of this activity, participants should be able to, one, review research to support development of safe and effective digital therapeutics, describe strategies to accelerate the delivery of digital therapeutics to patients, and improve substance use disorder treatment outcomes. Also, really describe NIH-supported and FDA-authorized digital therapeutic options for patients, and lastly, discern which technologies constitute digital therapeutics, gain a deep understanding of digital therapeutics as standalone treatments, and integrate it for substance use treatment, FDA-approved medications. And lastly, identify the FDA authorization process for digital therapeutics. So why the need for new treatment options? And that is a very loaded question, and I would say the backdrop for such a question would be the COVID-19 pandemic, and that really exposed the health care system in a way that really traditional methods for delivering interventions, there have been some drawbacks in terms of the way in which treatments are delivered and the care in which may be difficult to access by patients. So rural as well as urban health care deserts highlight the need to expand these options to increase access. And in many cases, treatments have demonstrated, and in terms of the COVID pandemic, that these treatments can be limited or even impossible to access. One of the most promising methods is the use of digital therapeutics to address this public health challenge. And earlier this year, the White House Office of National Drug Control Policy announced its priority to expand access to evidence-based treatments, and that includes digital therapeutics for addiction, in addition to others, and with a specific note to stimulant use disorder. So when we think about the landscape of digital therapeutics and digital tools in general, it's important to really disentangle what are digital therapeutics and what are they not. And before I go into what they are, I just want to note that this is NIDA's perspective, the National Institute on Drug Abuse's perspective on digital therapeutics and what we classify as those that would be a digital therapeutic. And digital therapeutics are mobile, web, and other software-based platforms that deliver effective treatments. These include those with the intent or with the indication to prevent, manage, treat a medical disorder or disease. Digital therapeutics are not general wellness apps or telehealth, which provides remote access to a clinician, and these interventions, these behavioral interventions that typically require face-to-face interactions can be delivered in part or whole by the digital therapeutic. So in a nutshell, digital therapeutics themselves are the software platforms that deliver the behavioral intervention, the effective treatment, with the intention of preventing, managing, or treating a medical disorder or disease. So the NIDA priorities on digital therapeutics really cover four distinct areas, and the first is to improve treatment efficacy. And we see improving treatment efficacy as really important to ensure that the intervention is addressing the core behavior that is targeted. And we also prioritize ways to integrate behavioral interventions, having defined mechanisms of action with a standardized therapeutic delivery. And the literature has really demonstrated three areas that have known mechanisms of action with regard to behavioral treatments, and the first is self-regulation. There have been some really robust studies to demonstrate the unique contribution that self-regulation has on behavior change. The other is stress reactivity, and finally, interpersonal processes. So when describing some of those processes in place, it's important to really think about how that would be a priority insofar as really honing in on the key elements of a behavioral intervention. So those are key candidates when we discuss what are some possible mechanisms of action. We also prioritize technologies that boost the effects and increase the efficiency of the intervention and produce technology-enhanced treatments that are implementable as well as self-sustaining. And those are really, I would say, the four key priorities with regard to digital therapies. So what are some notable advantages? I'll talk about some disadvantages, and that will be an open discussion, but there are several advantages that I would say digital therapeutics offer, and that's really specific to substance use disorder, and I think digital therapeutics can address some of the limitations that I noted in my previous slide. And the first is reproducibility. With the digital therapeutics, there is a focus on reliably delivering the intervention, and which also would require limited staff training, and it could really foster some quality control with regard to following evidence-based guidelines. So reproducibility from a research perspective is important. And the other aspect of the advantages that digital therapeutics can offer is engagement. And it's been noted that digital therapeutics can encourage engagement, and having an intervention available 24 hours a day as needed is a unique benefit that digital therapeutics offer. Third is reach, and there has been limited treatment access partly accounts for the reasons 80% of individuals in need of substance use disorder treatment do not receive it. And digital therapeutics, I would say, have the potential to eliminate some of those issues and minimize travel to a clinician, for one, and increase treatment options, for example, in rural areas. So that could be one of the advantages of digital therapeutics. Privacy is another. As many of you well know, that stigma is a critical issue for many patients when considering treatment, and enhanced privacy could help address stigma. Digital therapeutics provide enhanced privacy and discreet and confidential care, helping to address stigma associated with substance use disorder in its treatment, not in its entirety, but certainly it does provide that level of confidentiality. Cost is another advantage that digital therapeutics do not require active interventions or active interactions with a clinician, reducing face-to-face contact. So this could really offer a blended care approach that combines in-person as well as digital strategies going forward. So some blending of the two has been shown to be very effective. And finally, data recording, and I'm not listing any of these in any priority order, but just to note some of those notable advantages. And digital therapeutics can facilitate the recording of data that physicians collect during their in-person treatment sessions so that they can facilitate patient recording of symptoms and other areas that would certainly provide some offloading of activity. So I think digital therapeutics really offer a host of advantages for consideration. So that is kind of a, it's not an exhaustive list, but I just wanted to highlight some of the notable advantages that digital therapeutics offer, including and not limited to reproducibility and recording. So with that said, I think it would be important to really open the discussion in a chat form, if you wouldn't mind thinking through some of these questions and providing a response in the chat. And as I noted several of the advantages, I wanted to really pose these questions and to really stimulate some discussion. And are there ways to establish and maintain rapport with a digital format? And so there is a unique balance between digital health and interpersonal contact. As you well know, rapport is an important aspect of the clinical enterprise. And so I wanted to really pose this question to this audience today and really think through that balance of digital health and interpersonal contact. The other area for discussion is how will digital therapeutics intersect with health disparity populations in the area of addiction? I don't profess that digital therapeutics is any panacea, not a silver bullet in any way, but might digital therapeutics, how might they interact with health disparities populations in the area of addiction? Are there aspects to consider that have not been well studied? So that is an important aspect to discuss. And lastly, healthcare system requirements, including HIPAA compliance. So with those questions, I wanted to really pose those questions and encourage anyone and I would encourage some good feedback and ideas on that, those three questions there. So, Dr. Acklin, we did get something in the chat, I'll read it off for you. Certain proponents of accelerated Medicare coverage have argued that FDA's determination that a product meets applicable safety and effectiveness standards for marketing authorization should be sufficient to support Medicare coverage of breakthrough devices. However, after further consideration of all public comments, we no longer agree that the FDA safety and effectiveness standards alone are sufficient to support open-ended Medicare coverage. FDA and CMS act under different statutes that have different goals and the standard of coverage that is a determination that a device is reasonable and necessary for the diagnosis or treatment of illness or injury to improve the functioning of a malformed body member is not synonymous with standards for safety and efficacy standards for marketing authorization for the broader population. Sorry, that was a mouthful, but that was a comment that we received. I don't know if you wanted to discuss that. Yeah, I mean, and that's a very important question. And part of the discussion here is on the clinical validation, but the reimbursement aspect is an important element to that as well. And ultimately, the goal is to get clinically validated treatments to patients, right? And so that is, I would say, if we were to list the top three questions, I mean, that is up there as one of the top three remaining questions to answer. And how that will be resolved, I'm not exactly sure, but I think in terms of the research support behind digital technologies and ensuring that there is some level of rigor and some level that a patient who is at the end as the consumer would be able to discern from the hundreds of digital options out there in the marketplace. So again, I think the question is a really good one and will require, I think, a lot of collaboration between agencies and others that could really address those key questions. And so I don't think there's any one entity who could do that alone. And I think that will require a very synergized approach to address that question. So that's a fantastic question. Thank you so much for that feedback. Someone else commented, I've been using FDA cleared digital therapeutics for the past two years, found them very useful as adjunctive treatment to existing in-person treatment. Yeah, and some of the studies that I'll talk about later on in my presentation address that specific issue as an adjunct and that writer is spot on in that the data are very clear that this could be an effective tool for increasing, and especially among individuals who may not have achieved a level of abstinence at treatment entry and that digital therapeutics can be an important kind of jumpstart for a treatment in terms of retention and substance use reduction. So I'll talk a little bit about some of those specific findings, but that writer is spot on in that they have been found to be effective across as an adjunct to existing treatments. Thank you. And one more, DTX has been, oops, jumped up in my chat, has been very helpful in my small practice during the pandemic as adjunct therapy. The program that I use allows both patient and clinician interaction that has been really important, but also does not replace our relationship. So I think, and that writer is, I mean, that's a very important comment in that really finding that balance, and if you think about how this could be used as a complete or in a complete model of care where that is part of one's armamentarium to address addiction, I think that is really an important approach. So I think that's a great comment and one that we would hopefully in the future would be commonplace that this would be part of a complete model of care. Thank you. And then there are some questions, but I figure we can save those for the Q&A at the end. Great, great. So we will circle back to these questions and others that I will pose later in the presentation, but thank you for those questions and keep those comments coming in. I certainly appreciate it, and this will likely be, and I've already demonstrated that this will be a fruitful discussion. So thank you for those. So let me move on to the overall landscape of digital therapeutics. And this is something that really we thought long and hard about at the National Institute on Drug Abuse, specifically in the Division of Therapeutics, is the overall landscape. And as you might imagine, there have been a rapid shift over the last decade with the development of digital therapeutics or digital tools. And many of those that are in the marketplace or available have not been clinically studied. And that has really caused us to think through how do we really focus in on those that we can ensure has the clinical validation, the scientific rigor that we expect from medications, for example, and or devices. And so that is really one area that we really took an honest inventory and established really a partnership. And I'll talk a little bit about that, of where we wanted to move this really landscape that is out there. So as you might imagine, the development efforts have far outpaced validation studies. And if you were to do a quick Google Play search or go into any of the Apple stores, there are over hundreds. There are hundreds of touted digital tools, right? And I'm not saying it's specific to substance use, but general health or others. There are hundreds that really are touted to address specific issues. So with that landscape, it is important to really bring some type of order and ensuring that there is a trusted entity responsible for reviewing the clinical effectiveness and usability of digital therapeutics, as well as authorizing digital therapeutics that are worthy for patient consideration. And to me, I think those two are really at the core of why this process can be an important one. Not to say that it's the only one, but an important one in that it is ensuring that patients know what are worthy of their consideration. So in essence, it is to bring less chaff, more wheat to this overall landscape. And that was really at the impetus behind us moving in this direction in a way that really moved our portfolio. So the question here is to validate or not to validate? That is the question. And the reason why that is the question is with the target population, it's important that the validation in the target population for digital therapeutics have the same level of rigor as traditional medications and or devices. And that's full stop why I think the validation aspect of this is important. And so the reason why NIDA values the FDA process is that it provides an independent assessment of risk, safety, and effectiveness. And that's similar to the process that medication development undergoes. So that is, again, a key feature and a key aspect of why this is an important process and why NIDA values this specifically. And currently, digital interventions can be given without FDA review and authorization. And whether FDA review, and this is speaking to one of the comments that came in earlier, requires depends on several aspects, including the level of risk associated with the intervention. And also, while several products on the market were tested in clinical studies and shown to be effective, there is no standard that patients can rely on to be ensured of their efficacy. And so that is, I think, is the important area that is worth noting and highlighting is that the patients can rely and be assured that this is an efficacious and effective intervention. So let me switch gears and really to note that oftentimes the treatment population for substance use disorders are at high risk, and both during the cessation phase of treatment as well as when a patient, if a patient, might relapse. So that is something that is important when we think about the clinical validation process. So how do we really come to this whole process of the FDA and NIDA? And this is a joint partnership, a memorandum of understanding that was established in 2019 that allows regular contact between agencies and sharing information about digital therapeutics. And we prioritize in this MOU three areas for development. First is funding opportunity on digital therapeutics for substance use disorders, which is available currently, and I'll talk about that in a subsequent slide, and develop collaboration on presentations as well as to applicants on the authorization process. This is not a terribly old process. This is something that many developers and others, again, when you think about the landscape, this is not a process that many have used or are familiar with. So the goal is really to provide that insight across agencies to applicants on the authorization process. And we also prioritize developing a joint commentary on research priorities and validation process. So this MOU, in short, provides guidance to grant applicants to help navigate this process on submission as well as authorization and accelerate the progression of these technologies through the regulatory path. So in short, those are the three areas that we prioritize and have decided to focus on as the steps forward across agencies. When thinking through the FDA regulatory pathways for digital therapeutics, I just want to go through some of the areas that are worthwhile to consider. Not everything applies to digital therapeutics, but I just wanted to provide a brief snapshot of the regulatory pathway. So as I mentioned before, general wellness is one area, and those are low-risk devices that do not make diagnostic or therapeutic claims. So these that classify as general wellness do not need clearance. There is the premarket approval pathway that are germane to high-risk Class III medical devices. That FDA inspection is required. This is not relevant to digital therapeutics but would apply to, I would say, things like deep brain stimulators, for example, pacemakers, that type of invasive type of tool. The 510K pathway is low- to moderate-risk devices, must demonstrate equivalence to a predicate device. FDA decreasing 510K submission in favor of de novo, and I'll talk about the first authorized digital therapeutics that received that de novo pathway, which is novel to low- to moderate-risk devices, a new product classification. And finally, this was noted also by someone in the chat about the Breakthrough Devices Program giving priority review for medical devices and device-led combination products. And this is really to put those products that are, again, breakthrough status at the top of the queue for review. So I wanted to really go over this interaction of this process interacting with the FDA. And this is just a sample of early interaction. And FDA's Center for Devices and Radiological Health, and I should mention that as part of the MOU, so it's between NIDA and CDRH, they review the treatments that meet the definition of a medical device for safety and effectiveness. And so the FDA has established mechanisms like this that I laid out here in front of you as the voluntary pre-submission process or queue submission, which provides opportunities for developers and investigators to engage in discussions with the FDA about their products. So for example, developers can discuss topics such as regulatory requirements that may apply, if any. So again, not every digital therapeutic would undergo this process, but they would determine at that time whether or not any regulatory requirements would apply. The appropriate regulatory pathway that the digital therapeutics meet, the definition of a medical device, clinical study design considerations, including the proposed patient population, as well as study endpoints and assessments, study comparators, data analytic plans, et cetera. And also, which is important, is the cybersecurity measures to consider. And so that is, I think, the value that NIDA sees with the FDA process and this pre-submission or queue submission process. And this provides an opportunity to obtain FDA feedback prior to the IDE or marketing submission. They provide written feedback on the, or an optional meeting. The pre-submission are not intended for pre-review of data. And the purpose is to clarify feedback, not respond in real time to new information. So I listed the guidance document here for further review and consideration. And this really just outlines the pre-submission process that really sets the stage for the aspects of priorities and clinical validation. So let's really switch gears to how this is classified, the medical device definition. And the definition of a medical device is specified in Section 201H of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 321. And there you will see that this lists the term device, meaning an instrument apparatus implement, including any component, part, accessory, which is intended for use in a diagnosis, goes down to cure, mitigation, treatment, or prevention of disease. The other definition is intended to affect the structure or any function of the body. And it goes down to the following, but I just wanted to underscore those areas on the intended use. And that's really where we think about kind of demarcating what meets the criteria of a medical device definition is the intended use for diagnosis, cure, mitigation, treatment, or prevention of disease, and or affect of structure. So the first definition would be germane to some digital therapeutics. So that would really fall into the category of a medical device definition. So again, emphasizing that not all digital therapeutics meet that definition. So when is an IDE needed? And that is an investigational device exemption. And so when a device is a significant risk, and that is, takes into account not only the device, but the target population the device is intended to be used in, in the overall study design. So 21 CFR 812.3 defines significant risk as one intended as an implant to purported to purported or represented to be used for supporting sustaining human life, sustaining the, or, or substantial importance in diagnosing, curing, mitigating, treating disease, and otherwise preventing impairment in human health, and serious risk to health, safety, and welfare. So there it's, it should be noted that when we talk about the overall study, the target population includes, you may have it where the device itself may not be significant risk, but the target population. So for example, may have a patient population or a higher risk for suicidal ideation, for example, or suicide risk. And even with risk mitigation, mitigations put in place in the study design, the study could be considered a significant risk. So again, this really classifies, can be in the, the device itself and or the target population. So the study risk determination, this is an opportunity to obtain FDA feedback on whether your proposed study is significant risk or non-significant risk study. And the FDA provides a written letter outlining whether the proposed study is determined as significant risk or non-significant risk. Here too is the guidance for the study risk determination. So switching gears into developing these digital therapeutics for substance use, substance use disorder and points to consider. So I don't want to, I won't go too deeply into all of these points, but I just wanted to highlight several points of consideration while we're on the topic of clinical validation, because I think it's important to highlight the areas of behavioral treatments that have provided decades of research, in many cases, like contingency management that we know works extremely well and very powerful, and other interventions, other cognitive behavioral treatments, and others that have really shown to be effective. So the design considerations take into consideration the type of behavioral therapy, how does this device implement the principles of behavioral therapies, the indicated use can be as an adjunct or a standalone intervention, and also non-clinical testing considerations are also an important consideration when thinking about developing and evaluating this as software validation. And so this is some guidance on the content of pre-market submission for software contained in medical device. And as I mentioned at the outset, we are considering digital therapeutics as those software platforms with the intention of treating, managing, or preventing substance use disorder. Other clinical testing consideration include human factor and usability testing, as well as applying human factors and usability engineering to medical devices, as well as ways to evaluate safety and effectiveness in a clinical trial. Those are ideal study testing considerations, and I just wanted to highlight the FDA guidance on that in terms of usability engineering medical devices. So medical device trials differ from drug studies in many ways, and device studies are designed to support a reasonable assurance of safety and effectiveness, and that is really the goal of devices and how they differ from medication trials, for example. And endpoints of interest can be highly diverse between studies, dependent on indication for use being sought, and clinical trials should be designed to support the indication and target population. So I just wanted to note several other points to consider and recommend evaluating the safety and effectiveness of a device in the population for which it is to be indicated. So whether or not it is specific versus general use, and time frame should be delineated in the research study itself, evaluating the primary endpoint. So considering the time course of the specific substance use disorder, and do patients have an initial immediate response and or relapse, so the time course of that is an important aspect of these clinical validation studies. An endpoint should be pre-specified to include one or more safety endpoints, as well as one or more effectiveness endpoints. Right, so additional points should include sham control versus usual care, and when applicable, considerations need to account for placebo effects, and treatment groups having equivalent time on task. As I mentioned before, adjunctive use or standalone patients can be on usual care, but the protocol should delineate what usual care constitutes. So that is an important demarcation here on adjunctive approaches. And if used as a standalone, protocols should have specific plans for patient safety. Protocols should plan for how patients will be washed from medications or other usual care when applicable, and also need to account for placebo effects. So those are, I would say, important areas to consider when developing these studies or evaluating these studies for effectiveness. And I highlighted some inclusionary criteria as well that is important for the target population, and some statistical considerations as well. So I won't go over all of those, but I just wanted to note those as part of these points to consider. Right, so coming to our next discussion, and I wanted to really pose this as the second question to think about endpoint measures for digital therapeutics. And when measures are obtained from a digital therapeutical mission can be used to provide clinically meaningful data on how a patient feels or function. And I think, you know, the question here now is, are there ways in which digital therapeutics could give bias assessment? And so that is really a question that I wanted to pose to the audience today, and provide your thoughts and comments in the chat on whether or not digital therapeutics could give bias assessment. And I think the other question is the value on really correlating and making sure that independent biomarkers confirm subjective reports as well. So I think it's a balance. And again, we're getting back to the first question about that balance. So that's something that feel free to provide your thoughts, feedback, suggestions, comments in the chat. And with regard to digital therapeutics and how it's differed from medication is that FDA only has the ability to authorize non-medication, which is distinct from the approval given to medication. So that is something that is important to know is that the FDA has the ability to authorize and not approve given in their authorities. And Dr. Acklin, while we wait for folks to make their comments in the chat, some people did say that your voice is trailing off a little bit. So I don't know if maybe the microphone's a little bit too far away. It's not picking up on some of the quieter things you say. All right. Well, thank you. Thank you very much. Is this better? Yes, that's perfect. Okay, great. So I'll break for a second and see if there's any comments in the chat. Let's see, given on time, let's just hold off on that and then circle back at the end so I can go through the data here. And I will say that the changing landscape really, the Affordable Care Act, I will say, really set the stage for digital therapeutics in many respects. And in 2017, the FDA approved the first digital therapeutic for substance use disorder treatment from Paratherapeutics. And so they launched a commercial version of the therapeutic education system called RESET. And this study demonstrated improvement in substance use abstinence and increased retention in outpatient program compared to outpatient treatment alone. So there you can see the data across from the days on the trial and the B-frame there at the bottom right. And you can see the retention 80% compared to 64% when combined as an adjunct to standard therapy, which is pretty remarkable. And which is particularly of note is that this was effective among those who were non-abstinent at treatment entry. So I highlighted that initially. And so the paratherapeutics utilize the FDA de novo classification pathway for the approval or the authorization of this digital therapeutic. So I won't go into, but just to say that NIDA has really been supportive of digital therapeutic studies. This is one, the first R43, R44 is a project that I launched back in early part of 2019 to establish digital therapeutics as adjunct to increase medication adherence and really to focus in on behavioral interventions that we know have a robust literature like contingency management. So the goal here was to provide primary endpoints that for example, adherence to FDA approved medication, reward and contingencies to be delivered in a self-sustaining manner. So this is to provide a complete platform to deliver reinforcement. And so that is one, and we currently have available developing digital therapeutics for substance use disorder with specific indications highlighted below. I won't go into all of the examples, but I just wanted to note some of the examples here and really focus on finalizing and validating digital therapeutic in the study population, really honing in on efficacy endpoints, for example, dependence days of abstinence. And I wanted to highlight several others, but I won't go through this exhaustive list, but I just wanted to highlight some of the key priority areas that are some exemplars during the UG3 phase of this funding opportunity. So as another example is a recent study that was published last year in 2020, that focused on smartphone-based incentives to prevent smoking cessation during pregnancy. And you can see in the chart here that there's a comparison between incentives and best practices and this digital intervention based on contingency management developed by Dynamicare showed increased smoking cessation in women smokers during and after pregnancy compared to best practices. So the primary endpoint was biochemically confirmed smoking abstinence. And there you can see from early pregnancy all the way through 24-week postpartum, from early pregnancy all the way through 24-week postpartum, the incentive group was very robust in terms of smoking and abstinence throughout the process. So that was, I think that's another important aspect of digital therapeutics to highlight and the effectiveness of, for example, contingency management. So I know we're getting close on time. I want to make sure to get through all of these remaining slides, but this slide in brief is really to highlight a study that was done back in 2008 that showed digital therapeutics was as effective as clinician-delivered treatment. And this was in a medication treatment for opiate use disorder and both being superior to standard care. So that was, I think, an important endorsement of digital therapeutics that can be used in ways as an adjunct, but I think studies to really demonstrate how effective as standalone, but more work is needed in that regard. Another study before I close and open it up for discussion here is a recent randomized clinical trial on novel smoking cessation treatment for patients with serious mental illness. And this is a study that was funded by NIDA and to evaluate learn to quit, which is based on acceptance and commitment therapy that focuses on smokers with serious mental illness. So as you can see in the comparison, which the data are very compelling on the smoking behavior on reductions in cigarettes per day, you can see 12.3 compared to 5.9. And if you were to look at the bottom smoking abstinence, the 30-day point of abstinence, 30-day point prevalence, 12.1 compared to 3.1, which is, I mean, I think that's an important demonstration that how effective this can be. I think what's even, I would like to highlight even further is the usability and engagement data. And if you look at the app interactions, the learn to quit 847 app interactions compared to quit guide, which was the comparator in this study, 2.5. I mean, that's astounding in terms of how important engagement is when developing and really evaluating digital therapeutics. And the app duration in hours is also an intriguing metric to look at levels of engagement. So that has a direct correlation with the reduction in cigarettes per day, as well as 30-day point prevalence. So I just wanted to make note of that in terms of the clinical validation elements that I described throughout. Also engagement is, I would say, an important aspect of this as well. So I just wanted to close before we open up the discussion again to really focus in on why this effort we see as very important at the National Institute on Drug Abuse. And the FDA pre-market review is especially important in our view, given the growing number of marketed digital health solutions. And again, going back to the Google marketplace and Apple store, et cetera, many of which those products have limited to no clinical validation. So the FDA marketing authorization provides an important line of demarcation, giving patients and healthcare providers assurance about safety and effectiveness. Again, from a research perspective, the ability to have a tool that is reproducible and provides high fidelity is an important feature. So digital therapeutics that meet the definition of a medical device is safe and effective for its intended use. A prescription digital therapeutics receiving FDA regulatory authorization is required to demonstrate good manufacturing practices, data integrity, as well as compliance to quality system regulations. NIDA is committed to the treatment of substance use disorders, investigating or investing as well as investigating scientific and theory-informed digital therapeutics. Digital therapeutics help in many ways, maintain the potency of the behavioral intervention, become more easily implementable and sustainable to state-of-the-art practices. And the goal of the partnership between FDA and NIDA is the partnership goal in terms of improving design, development, and methods for delivering these interventions. And finally, I think the point here in all of this is really to not replace a clinician, but to really add to the armamentary of substance use treatment options for providers and giving patients the opportunity to help them understand and to help tease apart what are some of the effective digital therapeutic options out there and help really to separate the chat. So with that, I wanted to open up our general discussions before I get into any of the other aspects of the presentation in our final eight minutes. So I just wanted to really pose a general discussion on how the information presented today applied to your discipline or practice and how do you see any of this, any of the digital therapeutic interventions or any of the work details here fitting in your setting and your healthcare team. And so I just wanted to pose that final question to you all today. Thank you so much, Dr. Acklin. So folks, again, please raise your virtual hand if you would like to speak with Dr. Acklin. My colleague, Jennifer Lundstrom, will unmute you on her end. Additionally, you can post your questions to the Q&A. We have had some questions posted to the Q&A, so I will read those to you. Let's see. What are the apps that you recommend for DTX? So I'm very careful because I don't want to come across as endorsing any digital therapeutic, but I just wanted to really highlight what we look for in terms of scientific rigor, what we look for in terms of meritorious science. And so as opposed to describing kind of an exhaustive list, I just wanted to provide a few exemplars. So that's my way of saying that what we look at is ways of discerning the clinical validation process. And again, I think without providing any endorsement on any, really the projects that we have funded, they are peer reviewed. We know that it's rigorous in terms of the clinical design, et cetera. And that's why this partnership I think is so important in that there is that line of demarcation to ensure that there is an independent entity that can review on the safety, the effectiveness of these technologies. So again, that stamp of approval is an important aspect to this entire focus on digital therapeutic. So I don't know if I answered your question, but that's kind of my thoughts on that. Thank you so much. We have another question. If physicians and patients are utilizing the tool for the purpose of data entry, is the technology intended to integrate with an EMR or is it a standalone cloud-based product? Yeah, so that is a great question. And I know that there are products out there that correspond with EHR and others. So we have a very robust SBIR program that have really exhaustively looked into those types of questions. So there are some that link with EHR and some that do not, but that is an important question. And I think part of that general discussion is really how that might enter with HIPAA, for example, and ensuring that all of the infrastructure, for example, is built in place that would be able to talk between those types of devices and EHR. So I think that's an important question and that should be factored into building into those that would go forward as a digital product. Thank you very much. And we have another question. Could this be offered as a supplement to medications? Again, I think it certainly has been. There have been studies to look at or ongoing studies to look at digital therapeutics as standalone. There are those products that look at as an adjunct to behavioral treatments and those that really focus on adherence to FDA approved medication. So there are specific indications that some are seen as standalone. So the answer is yes. This can be used as a standalone option or some examples can be used as a standalone option and others that are used in combination with FDA approved medications. So yes. Great, thank you. Let's see. I think we have time for about one more question. If the digital therapeutics are available 24-7, I presume they are pre-recorded. How can the patient then interact with the therapeutic tool in real time? So the digital therapeutic that I described here, there's no clinician interaction. It is 24 hours insofar as there are modules of the intervention that can be accessed on demand. So you have access as you would with any other app on your phone, but it's the treatment that you have access to. The treatment modules that you would typically have in a face-to-face interaction with a clinician, but it's the digital therapeutic itself that the patient has access to in the various modules that comprise the behavioral treatment. Great, thank you so very much. Let's see. Yes, you can go ahead and proceed. I know we're on. I just wanted to highlight some of the FDA guidance documents and I know that I don't expect everyone to memorize this at all, but I just wanted to highlight that for reference and some references here. And should I note, Jen, I'll go over. Yes, you can go ahead and jump right in. Okay. So I'd like to make you aware of two resources offered through PCSS that may be of interest to this audience. First, the PCSS mentor program is designed to offer mentoring assistance to those in need of more one-on-one interactions with one of our colleagues to address clinical questions. You have the options of requesting a mentor from the mentor directory, or you can be paired with one. To find out more information, please visit the website using the link provided below. Second, PCSS offers a discussion forum, which is comprised of PCSS mentors and other experts in the field who will help provide prompt responses to clinical cases slash questions. There also is a mentor on call each month. This person is available to address any submitted questions through the discussion forum. You can create a new login account by clicking the image on the slide to access the registration page. This slide simply notes the consortium of lead partners organization that are part of the PCSS project. And finally, please reference this slide for contact information, website, Twitter, and Facebook handles to find out more information about resources and educational offerings. So with that, I know we're on time at two o'clock, so I want to thank you for your time, your attention, and questions. Thank you very much. And thank you, Dr. Acklin. We really appreciate you presenting today on this topic, and thank you all for joining.
Video Summary
Dr. Will Ackland, Director of the Behavioral Therapies Development Program in the Division of Therapeutics at the National Institute on Drug Abuse, presents a webinar on digital therapeutics for substance use disorders. He explains that digital therapeutics offer a complete model of care by delivering interventions with fidelity through a seamless delivery platform. He discusses the importance of clinical validation for digital therapeutics and highlights the partnership between the FDA and NIDA to review and authorize these interventions. Dr. Ackland also emphasizes the need to improve treatment efficacy, integrate behavioral interventions, and prioritize technologies that enhance the effects and efficiency of interventions. He presents research studies that demonstrate the effectiveness of digital therapeutics as adjunctive treatments for substance use disorders, including for smoking cessation and opiate use disorder. He explains the FDA regulatory pathways for digital therapeutics and the importance of endpoints and clinical testing considerations. Dr. Ackland also discusses the potential advantages of digital therapeutics, including reproducibility, engagement, reach, privacy, and cost-effectiveness. He concludes by highlighting the value of digital therapeutics in expanding treatment options for patients and integrating them with traditional care models.
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Keywords
Dr. Will Ackland
Behavioral Therapies Development Program
Division of Therapeutics
National Institute on Drug Abuse
digital therapeutics
substance use disorders
clinical validation
FDA
NIDA
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