Digital Health Technology Derived Biomarkers and Outcome Assessments for Remote Monitoring
Rakonda Medley: Good afternoon, everyone. We will get started in a couple of minutes. Rakonda Medley: Okay, we're going to go ahead and get started. Good afternoon, everyone. My name is reconda medley and welcome to the digital health technology derived biomarkers and outcome assessments for remote monitoring and endpoint development. Webinar, we have a full house, so we will start off with a presentation of slides, followed by questions and answers. Please submit your questions in the chat section feature below, and they will be answered at the end of the presentation we ask that you please always remain muted and keep your video off. Rakonda Medley: The presentation will be recorded and placed on our Youtube page. I will be sending that link along with the presentation slides to everyone that has registered. I will now turn it over to our Program. Director, Dr. Carol Taylor Birds.
Carol Taylor-Burds - NINDS: Thanks for conduct and thanks everyone for joining. Today. Carol Taylor-Burds - NINDS: We do have a lot to cover. So we're gonna jump right in. Carol Taylor-Burds - NINDS: Briefly, we're going to be going through a little bit of background. We're going to do some introductions about the program staff Carol Taylor-Burds - NINDS: on today and then get into some background funding opportunities. Some terms that people need to be familiar with Carol Taylor-Burds - NINDS: the scope of the the funding opportunity. And I each participating institute focus areas. Carol Taylor-Burds - NINDS: And then we will wrap up with some question and answers.
Carol Taylor-Burds - NINDS: and, as Donna said, we ask everybody to hold the questions till the end. Carol Taylor-Burds - NINDS: but feel free to start entering them in the chat as they come up. Carol Taylor-Burds - NINDS: So I'm Carol Tilbert. I'm a program director at the National Institute of Neurological Disorders and stroke in our translational division. Carol Taylor-Burds - NINDS: I'm joined here by my colleagues, and I'd ask each of them to just briefly introduce themselves. Carol Taylor-Burds - NINDS: Starting with my colleague, Dr. Christy Hardy.
Kristi Hardy: Hi, I'm Christy Hardy. I'm a program director in the division of clinical research at Ninds. And Kristi Hardy: I am certainly somebody who can also answer questions about any and yes and and yes, participation in the snowfall, along with Carol. Carol Taylor-Burds - NINDS: Thanks, Christy, and data. TELEPHONE_USER: Hi, everybody! I'm Dana Wolf Hughes. I am a program officer in the Division of Cancer Control and Population Sciences at the National Cancer Institute. And I hold a portfolio that includes digital health technologies, data, science and risk factor assessment. yuan Luo: Hi! My name is Yuan Law. I'm the program director with the National Institute on Aging, and with the branch of clinical intervention and diagnostic branch.
yuan Luo: I manage the applications related to the biomarkers, including digital technology direct bumachers. yuan Luo: Thank you for coming. Carol Taylor-Burds - NINDS: Thanks everybody. Carol Taylor-Burds - NINDS: Alright. And I. We also have with us. Carol Taylor-Burds - NINDS: Dr. Sadisa, silou and Centil gounder, who are health program specialists at Ninds, and will be moderating our Q. And a. This afternoon. Carol Taylor-Burds - NINDS: as well as reconna medley our operations Coordinator, who you met already.
Carol Taylor-Burds - NINDS: and with that we're going to ahead and just go ahead and jump right in. Carol Taylor-Burds - NINDS: So we want to start off by talking a little bit about why do we need validated, remote assessments? Carol Taylor-Burds - NINDS: And we know that it's critical to increase participation and representation in in clinical trials. Carol Taylor-Burds - NINDS: But we also know that many people can't participate because it's too challenging to travel to the clinical sites Carol Taylor-Burds - NINDS: because of barriers such as distance, time cost, etc. Carol Taylor-Burds - NINDS: The other major value of remote assessments is from the ability to gather more frequent measurements which may detect a response to an intervention that is missed when measurements are only made every few months or years.
Carol Taylor-Burds - NINDS: however determining what to measure how to measure it and how often to measure it, not to mention how to analyze and interpret the results requires significant development and validation, and requires input from multiple stakeholders. Carol Taylor-Burds - NINDS: So the goals of this funding opportunity Carol Taylor-Burds - NINDS: are to encourage collaboration across disease areas to pool resources and support research to generate the data needed for the development, analytical validation and proof of concept, clinical validation of digital health technology derived assessments and monitoring biomarkers Carol Taylor-Burds - NINDS: to be used as future endpoints in clinical trials for 3 or more disease areas. Carol Taylor-Burds - NINDS: Now, there is a lot packed into those goals, and we're gonna break that down just a little bit more to go over some of the terminology.
Carol Taylor-Burds - NINDS: So first, st what are we talking about when we're talking about digital health technologies? And these are often referred to as sensor based digital health technologies as well. Carol Taylor-Burds - NINDS: And these are a system that uses computing platforms, connectivity, software or software help and or sensors for healthcare and related uses. Carol Taylor-Burds - NINDS: And so within the scope of this funding opportunity, we're talking about things like wearable sensors, mobile application based cognitive or functional assessments Carol Taylor-Burds - NINDS: and at home in monitoring technologies. Carol Taylor-Burds - NINDS: So when we're talking about biomarkers and clinical outcome assessments, I'm not going to read these definitions to you. But essentially, a biomarker reflects a biological process, while a clinical outcome assessment reflects how a person feels functions or survives.
Carol Taylor-Burds - NINDS: Now an endpoint may be either a biomarker or a clinical outcome assessment, but in either case it requires you to define how the biomarker or clinical outcome assessment is measured when it is measured, and a number of other details that need to be developed in order to develop the statistical analysis plan when you're designing a clinical trial. Carol Taylor-Burds - NINDS: So for this funding opportunity, when we're talking about biomarkers or clinical outcome assessments. We're really talking about digital health technology derived biomarkers and coas. So ones measured by digital health technologies. Carol Taylor-Burds - NINDS: So 2 more terms, we want to just quickly cover Carol Taylor-Burds - NINDS: concept of interest, which is pretty straightforward. Essentially, what is the biological, clinical, or functional concept that you're trying to measure Carol Taylor-Burds - NINDS: and then context of use is a brief statement to clearly explain how and when your biomarker or clinical outcome assessment is going to be used, and that should really address how they will be used to complement or replace existing assessments Carol Taylor-Burds - NINDS: as well as why they're needed. Carol Taylor-Burds - NINDS: So there are a lot of different types of validation, and I think most people are familiar with the 1st couple of these right validation. Most nih research includes some form of constructor contact, validation. Carol Taylor-Burds - NINDS: So this funding opportunity goes beyond that, and also is looking at fit for purpose, analytical and clinical validation. To assess the performance of the digital health technologies when they're used as proposed. So the analytical validation
Carol Taylor-Burds - NINDS: and to establish, if the digital health technology derived biomarkers or clinical outcome assessments can identify, measure or predict the concepts of interest intended. So the clinical validation. Carol Taylor-Burds - NINDS: So just to sort of Carol Taylor-Burds - NINDS: pull us together a little bit in a sort of straightforward example, you know, if we're talking about something like sleep, disturbance, as the concept of interest that you want to measure. Carol Taylor-Burds - NINDS: You might have several different technologies that you could use to measure it, so say away a risk worn or a body worn sensor. Carol Taylor-Burds - NINDS: and then the endpoint itself is going to be something like the total sleep duration, the number of wake ups. And so you've got in within that measurement, the algorithm measuring the biometric data from the wearable sensors
Carol Taylor-Burds - NINDS: to determine if the person's asleep or awake, the quantification of time of sleep versus awake. The number of events of wake ups over, say, 24 h of the night. Carol Taylor-Burds - NINDS: And then how many days is the assessment going to be made? What's the frequency? How many weeks or months are going to be monitored? So there's a lot that goes into that endpoint development. Carol Taylor-Burds - NINDS: So I again, these slides are all going to be shared Carol Taylor-Burds - NINDS: and and just listing out some examples of the types of questions that need to be considered when you're developing validating endpoint. Not all of these apply to every use case, and there are certainly other questions that should be considered as well. But this is just to give some examples. Carol Taylor-Burds - NINDS: So we're going to switch gears and talk about the funding mechanism and funding opportunity itself. Now. Carol Taylor-Burds - NINDS: So this is a phased ug, 3 3 cooperative agreement. Carol Taylor-Burds - NINDS: and the 1st phase can be one to 2 years, followed by a second phase, which can be 3 to 4 years, but these cannot exceed a 5 year Carol Taylor-Burds - NINDS: period.
Carol Taylor-Burds - NINDS: And just a reminder that you need to include the application it within the application. Both phases need to be included. Carol Taylor-Burds - NINDS: So what about scope? So within the 1st phase. Carol Taylor-Burds - NINDS: and this is examples of types of activities that can be included. This is not an exhaustive list, but Carol Taylor-Burds - NINDS: the 1st phase could include things like device, selection and analytical validation. Pilot studies Carol Taylor-Burds - NINDS: to optimize how you're measuring the the biomarkers or outcome assessments. Carol Taylor-Burds - NINDS: You could include things like head-to-head comparisons of different digital health technologies to select the best performing ones or evaluate generalizability to see if you can use multiple devices to measure the same Carol Taylor-Burds - NINDS: endpoints.
Carol Taylor-Burds - NINDS: you could evaluate factors that might interfere with the precision and accuracy of the measurements. And then there are things like finalizing the protocols before you go into the 3 phase Carol Taylor-Burds - NINDS: establishing final statistical analysis and data management plans. And so on. Carol Taylor-Burds - NINDS: You could also include activities like developing user informed consent and training materials for the 3 phase Carol Taylor-Burds - NINDS: and Carol Taylor-Burds - NINDS: you can. And just want to point out that the Nih justice. The year published some consideration points for using digital health technologies in your informed consent. And so I'd really encourage everyone to take a look at that.
Carol Taylor-Burds - NINDS: And that link is also in the funding opportunity. Carol Taylor-Burds - NINDS: In addition. Carol Taylor-Burds - NINDS: you can include outreach activities to establish collaborations with communities that are historically underrepresented in clinical studies Carol Taylor-Burds - NINDS: which might include racial and ethnic minorities, individuals in rural populations or individuals with limited, limited English proficiency. Carol Taylor-Burds - NINDS: And this is actually going to be addressed in the community engagement plan, which is in the other attachments that we'll talk about in just a couple of slides. Carol Taylor-Burds - NINDS: So then, for the 3 phase. This is really going to be focused on doing that prospective, longitudinal clinical proof of concept validation study. So you're really looking at. How do these assessments perform. Carol Taylor-Burds - NINDS: If you can also include as part of your context of use if you want to, how do they? Carol Taylor-Burds - NINDS: how do they perform in response to a therapeutic or behavioral intervention. However, we want to point out, you know, these funding opportunities don't allow therapeutic clinical trials within the scope. So if you're evaluating the biomarker or outcome assessment
Carol Taylor-Burds - NINDS: in response or intervention, it needs to be as part of standard of care Carol Taylor-Burds - NINDS: or as an ancillary study to an existing clinical trial. Carol Taylor-Burds - NINDS: And then, if you're seeking or planning on seeking regulatory approval, then you can certainly include activities to support engagement with appropriate regulatory agencies such as an FDA critical path innovation meeting or one of the drug development tool programs. Carol Taylor-Burds - NINDS: So there are a few unique features of this funding opportunity that we want to just briefly touch on, to make sure people are aware of and and take a little bit more look at.
Carol Taylor-Burds - NINDS: And we're going to talk about most of these on the next couple of slides. Carol Taylor-Burds - NINDS: So first, st you know, we have all had many workshops, and we all know the importance of having partnerships with patient advocacy organizations, and really critical having people with lived, experience involved Carol Taylor-Burds - NINDS: in thinking about in terms of helping inform, study, design. Carol Taylor-Burds - NINDS: endpoint selection, and also thinking about, how do we increase community uptake? Carol Taylor-Burds - NINDS: So this is a little unusual for most funding opportunities. But this one does require that you include 3 or more diseases or conditions.
Carol Taylor-Burds - NINDS: And we're doing this because we really want to encourage not many, many different types of endpoints. They're all trying to measure the same concept of interest. But we want to look for where are their shared needs, and encourage some of that standardization Carol Taylor-Burds - NINDS: to happen early? Carol Taylor-Burds - NINDS: It also can help Carol Taylor-Burds - NINDS: to promote the collaboration and the pooling of resources because these are resource, intensive efforts. Carol Taylor-Burds - NINDS: And finally, I want to just point out that we're not going to tell you how to define a disease or a condition. So it's up to you in your application. You need to include, how are you defining it? And then you want to specify and justify how you're defining what is a distinct disease Carol Taylor-Burds - NINDS: or condition? And what's the shared endpoint needs across all 3. So why were they selected? Why are they appropriate?
Carol Taylor-Burds - NINDS: So again, the goals of the funding opportunity are to develop and validate remote assessments in order to get. Carol Taylor-Burds - NINDS: you know, help generate the evidence needed to get endpoints that can be used as primary or secondary endpoints in clinical trials? Carol Taylor-Burds - NINDS: And again addressing the context of use. Carol Taylor-Burds - NINDS: How would these be used? What types of clinical trials? And this is a broad definition. This might be therapeutic development. This could be rehabilitation studies. This could be behavioral interventions. But why are these types of assessments needs? Why are these concepts of interest important to measure? Carol Taylor-Burds - NINDS: And what's the limitation of existing assessments, you know? How are how are these going to be an advantage? Carol Taylor-Burds - NINDS: So there are a number of other attachments within the funding opportunity. The 1st 3 are required. Carol Taylor-Burds - NINDS: and we're gonna talk about the 1st one a little bit more. Carol Taylor-Burds - NINDS: Also, of course, if you're using an associated clinical trial, having the the clinical trial protocols and consent. Consent forms included is important.
Carol Taylor-Burds - NINDS: And then Carol Taylor-Burds - NINDS: if you're planning on commercializing, the technology or the software algorithms being used, then you'd want to include an intellectual property plan. Carol Taylor-Burds - NINDS: We assume most people are going to include letters of support from patient advocacy, organizations or collaborators, and so on. But technically, that's not a requirement. Carol Taylor-Burds - NINDS: So let's just talk about the timeline and milestones a little bit more.
Carol Taylor-Burds - NINDS: So first, st this is the information that's in the funding opportunity. Carol Taylor-Burds - NINDS: You want to include both quantitative milestones and qualitative progress milestones. Carol Taylor-Burds - NINDS: And we're going to talk about a couple of examples here.
Carol Taylor-Burds - NINDS: So we looked at funding opportunity or in the description funding opportunity. We have this ug, 3 3 phase mechanism. Carol Taylor-Burds - NINDS: And so you want to make sure that milestones should include both the annual milestones and the go no go milestones, and this can be up to 3 pages in the other attachments. Carol Taylor-Burds - NINDS: So the annual milestones are going to help demonstrate continued progress, whereas the go no go. Milestones are going to transition. Carol Taylor-Burds - NINDS: You know this is the transition point between the Ug, 3 phase and the 3 phase, and you want to think about these in terms of deliverables. Carol Taylor-Burds - NINDS: What are the deliverables? Boom that Carol Taylor-Burds - NINDS: 1st phase to show that you have what you need to move on to the 3 phase, and that it's going to be useful and feasible.
Carol Taylor-Burds - NINDS: So for the timeline and proposed milestones. These are just a couple of examples. Carol Taylor-Burds - NINDS: You don't have to use them exactly like this just to give you an idea of what we're looking for. Carol Taylor-Burds - NINDS: So a progress milestone for a ug, 3 phase might be something like completing the feasibility study. Carol Taylor-Burds - NINDS: Using the digital health technologies and obtaining input from people with lived experience to collect input on device selection, study protocols and so on. Carol Taylor-Burds - NINDS: And you're going to want success criteria. How do you demonstrate that you have successfully met this milestone.
Carol Taylor-Burds - NINDS: Then you want to briefly justify why you selected those success criteria. Carol Taylor-Burds - NINDS: So an example of a ug, 3 3 transition go. No go. Milestone might include something like Carol Taylor-Burds - NINDS: performance milestone, something where we're going to determine which of the digital health technologies tested in the Ug, 3 phase Carol Taylor-Burds - NINDS: met the performance criteria and can still be used in the 3 phase. Carol Taylor-Burds - NINDS: So success criteria might include things like the usability, accuracy, reliability, and so on.
Carol Taylor-Burds - NINDS: And again, you want to think about the justification in terms of why you selected those performance criteria. Why are those important to measure and and show? Carol Taylor-Burds - NINDS: So finally for a 3 phase, because this is going to be a prospective longitudinal study. You're going to be thinking about things like the recruitment Carol Taylor-Burds - NINDS: of the number of participants and the quality metrics used for obtaining the data. And you might also want to really think about not just the total number of participants. But are you mean sufficient numbers for each of the diseases or conditions, or the overall diversity goals. Carol Taylor-Burds - NINDS: And for all of these milestones, just remember that you really want to be quantitative, and you've got again 3 pages to to document this and include your timeline Carol Taylor-Burds - NINDS: and really thinking about, how are you going to demonstrate continued success.
Carol Taylor-Burds - NINDS: So non-responsive studies. Carol Taylor-Burds - NINDS: I won't read this either, but I really want to make sure that everyone takes a look at this in the funding opportunity. Because if you're a non-responsive study. You can be administratively withdrawn before review. Carol Taylor-Burds - NINDS: If you have any questions about whether or not you're eligible, please do reach out because this we don't want you to go through the effort if Carol Taylor-Burds - NINDS: if it's not going to be within scope of the funding opportunity.
Carol Taylor-Burds - NINDS: So I am going to. Now turn it over to my colleague Carol Taylor-Burds - NINDS: Christy, who's going to talk a little bit about the ninds effort. Kristi Hardy: So we just want to review research areas that might be of particular interest to the various institutes that have signed on to this effort and for ninds. Most of you are aware that we are going to be interested in applications that assess priorities for neurological conditions, and this includes conditions across the lifespan. Kristi Hardy: We particularly acknowledge that some of these measurements that may be needed if you're studying pediatric populations versus elderly populations, or others, may be really really different and require distinct efforts. And so we welcome responsive applications that address different areas of the lifespan Kristi Hardy: and this Nofo is particularly aligned with our most recent strategic plan. Kristi Hardy: and in that plan it was noted that ninds really is dedicated to developing and validating biomarkers and outcome measures as a specific priority, and another priority for our Institute is to promote health equity for individuals with neurological conditions, specifically, by supporting efforts to be inclusive in validation studies Kristi Hardy: and and to develop remote assessments that can hopefully promote inclusion and reduce barriers to participate in clinical trials.
Kristi Hardy: And Kristi Hardy: we also just wanted to talk about some related notos that you may want to check out as you are exploring it. Whether this or other opportunities may be the most appropriate mechanisms for your research studies. And so here are several projects and funding opportunities in which ninds is participating. That may also be really appropriate and relevant for your research that we encourage you to, to check out. Carol Taylor-Burds - NINDS: Thanks. Christy. yuan Luo: Hi! This is Yuan. Again, about the Nia interest. On this funding opportunity. We share many interests with nds and Nci. On developing this funding opportunity as a leading research, a Federal agent for research on Adrd research. We are focused with this no-fall to encourage applications to develop validate yuan Luo: and verification of remote digital monitoring biomarkers yuan Luo: and a digital clinical outcome assessment for age-related neurological disorders. And Adrd
yuan Luo: Adrd serve as an example what Carol mentioned for this particular novel. We encourage to shared outcome assessment for multiple diseases, so such as Adrds, Lbd. Ftd. And late and vascular related Vcid and mixed measures. yuan Luo: We also support the scientific collection of data, systematic collection of data and scientific analysis of data and disseminate of informations, interpret yuan Luo: clinical, meaningful informations. yuan Luo: Just know for Fitzvah Alliance with Nia mission as a.
yuan Luo: We know that age is a risk factor for many chronic diseases that impacts on social economics, and our mission is to meet these challenges by providing research support yuan Luo: for the genetic, biological and behavior, social research on aging. yuan Luo: and also to support the research resources and the information dissemination. yuan Luo: This also means the Nia Napa yuan Luo: research implementation milestones, for example, milestone 9 is to developing minimum invasive yuan Luo: biomarkers. And 11 is enable technology for disease monitoring. So those are identified experts and written into law in 10 years ago.
yuan Luo: and we also have joint effort to promote disease, to to promote health equity, because this is a perfect, remotely accessible biomarkers or devices can overcome those barriers for participations. yuan Luo: Thank you. yuan Luo: Oh, sorry. There are some related funding opportunities. The 1st one is a validation, clinical and analytical validation of biomarkers for ad Adrd, and this can be mostly can be fluid biomarkers. But it can also includes the digital derived biomarkers.
yuan Luo: We also have the notice of special interest for small business, for early detection, and also the next 1, 20 0 4 8 is for digital technology, for early detection. Adrd, which is r. 1 r. 21 mechanisms. yuan Luo: And as we see, this fits the pipeline for the digital biomarker development in an earlier stage and the current. There's no voice for the endpoint assessment. yuan Luo: And we also have recently proved the concept which has not released of any opportunities. Also, including
yuan Luo: the infrastructure building is a national center for accelerating use of a digital health technology, Adrd research that will create some repository harmonization. And so on. yuan Luo: And we also have approved for standardization of digital tools that are more suitable for small business applicants. yuan Luo: Thank you. Carol Taylor-Burds - NINDS: Great thanks, and Dana. TELEPHONE_USER: Thanks, Carol, so to give a little bit of an overview about Nci's focus for this funding opportunity. We're aligned broadly with anything that is in the Nci's mission and our scientific priorities which are outlined on our website and focus on the development and validation of cancer-specific digital monitoring biomarkers, clinical outcome assessments and endpoints.
TELEPHONE_USER: I do want to note, given sort of the requirement of this funding opportunity to have 3 or more sort of diseases that in cancer. We, we look at cancer as a group of diseases. And so applicants can define each cancer type or subtype. And so we include within this subtype definition, molecular subtypes as separate diseases as justified scientifically in your application. TELEPHONE_USER: Some areas that we are particularly interested in receiving sort of TELEPHONE_USER: applications in are proposals that look at addressing unmet needs in high risk, understudied or underserved cancer populations, and that includes individuals with, say, early onset cancers, rare cancers or pediatric cancer survivors, for example, as well as rural patient communities developing and validating digital TELEPHONE_USER: biomarkers to monitor cancer treatment, related symptoms, sequelae and or outcomes, and that could include, for example, adverse events, late effects, toxicity, pain, etcetera. TELEPHONE_USER: Those that are interested in maybe using a digital health technology that is collecting analyte data from an electrochemical dht is of interest. Those that are monitoring physiological status or clinical outcomes associated with physical function, nutrition, or dietary status, or outcomes related to physical fitness such as aerobic capacity or sleep or Circadian disruption.
TELEPHONE_USER: And then those Dht measured remote digital biomarkers to monitor treatment response and inform potentially down the the line treatment selection dosing and adaptive designs TELEPHONE_USER: next slide. TELEPHONE_USER: So in terms of related nofos, I want to sort of point out that these change all the time, and so I encourage everyone to go to the Nih guide, not just for Nci, or but just even for anything at Nih that's funded. A few of these include smart Health, which is an interagency program with the National Science Foundation and all the participating Ics. On this webinar TELEPHONE_USER: also participate in. There's 1 focused on academic and industrial partnerships TELEPHONE_USER: as well as a couple of no sees. One is a validation of digital health and AI tools
TELEPHONE_USER: that Nia is also signed on to. And then another one focused on technology development for cancer control and population sciences which is aligned with our Imat and Itcr programs. And so if you Google, Imat, Imat or Itcr, those are 2 programs that fund a lot of technology in molecular and information technology. TELEPHONE_USER: And then, lastly, there's a funding opportunity released out of Nibib focused on quantum sensing technologies next slide. TELEPHONE_USER: So I also want to mention that the office of behavioral and social Sciences research is signed on to this funding opportunity. This can sometimes cause confusion for the community. Because Obssr is not a funding agency, they are not able to hold and fund grants. They are able to work with individuals like Carol, Christy, Jan, and I to support research TELEPHONE_USER: that is going to be funded by Nih. And so we just want to note that. And if you are interested in something in the behavioral and social sciences reach out to one of us as the program officers, and we can connect with Obssr in the background TELEPHONE_USER: next slide.
TELEPHONE_USER: and then, lastly, in terms of the budgets for this initiative and the need for prior approval in the funding opportunity. It notes that budgets are not limited, but need to reflect the needs of the proposed project. TELEPHONE_USER: However, if you are going to request over $500,000 or more in direct costs in any year. Each of our institutes requires prior approval. TELEPHONE_USER: In addition, while these links here take you to each institute, I want to note that it's really important to reach out to one of us early and often about this, because each of our institutes have different processes and procedures for you to be able to gain approval, and so going to the links here are really helpful to get a general sense of what that looks like. TELEPHONE_USER: But also you're going to need to proactively talk to a program officer as soon as possible. If you anticipate this going over $500,000 or more.
TELEPHONE_USER: Next slide. Tjerignimin Adissa Silue: Thank you. So another important part of the application is the data managing and sharing policy. So Nih has a commitment to making the results of any research Tjerignimin Adissa Silue: available, and to also promote the sharing of scientific data. Tjerignimin Adissa Silue: Therefore, applications that are either planning to to generate data will need to submit a data and managing sharing plan. Tjerignimin Adissa Silue: These plans are not part of the scored Peer review criteria, but are going to be reviewed by the Nih program staff, and also those program staff will have to approve the plans prior to the award.
Tjerignimin Adissa Silue: So Nih does expect investigators to again plan and budget for the management of the sharing of the data as well as again submit the data management plan for review, but also comply with the approved data management plan. The link below also kind of gives more information about that, and also shares data, managing plan examples that can be utilized to formulate your own Tjerignimin Adissa Silue: excellent. Tjerignimin Adissa Silue: Finally, the receipt date. The 1st receipt date to this novel is February 21st 2025.
Tjerignimin Adissa Silue: The link to the notebook can have it has more information about the application due dates, upcoming, as well as the review and award cycles for the upcoming receipt dates in the future. Tjerignimin Adissa Silue: Looks like Tjerignimin Adissa Silue: again. We would like to thank you for attending the webinar, and we will now proceed to questions. Carol Taylor-Burds - NINDS: Alright. Thank you, everyone, and I'd invite my other colleagues to join the panel discussion. Now I see we've got a number of chats questions in the chat already. Carol Taylor-Burds - NINDS: and Adisa and Sentil are going to moderate that and read those. Carol Taylor-Burds - NINDS: and we will answer accordingly. Thanks. Senthil Gounder | NINDS: Okay? I'm reading the 1st question.
Senthil Gounder | NINDS: So the 1st question is, or the implantable device that record data like neurotransmit simulators and cardiac device. In scope of this project. Carol Taylor-Burds - NINDS: So if if it requires Carol Taylor-Burds - NINDS: so one is going to be about the use case, right? So is it for monitoring biomarkers or clinical outcome assessments? Or is it a therapeutic device? So a therapeutic device is not going to be within scope. Carol Taylor-Burds - NINDS: If it's for monitoring and can collect data remotely, then it would be within scope. Tjerignimin Adissa Silue: All right.
Tjerignimin Adissa Silue: Next question is, is there a direct to second phase, option? Carol Taylor-Burds - NINDS: No. So with small businesses that can be an option. But in this case you need to include both the Ug. 3 and the 3 phase. Senthil Gounder | NINDS: The 3rd question is already answered by Dan. Senthil Gounder | NINDS: So if clinical trials so Senthil Gounder | NINDS: not permitted, how would sensitive to change the digital biomarker to assist.
Senthil Gounder | NINDS: So I'm going to skip that one, and then I'm going to go to the next question. Senthil Gounder | NINDS: Can the study settings be skilled nursing facility or long term, acute care facilities? Senthil Gounder | NINDS: Or is the setting strictly pure, patient, outpatient. Carol Taylor-Burds - NINDS: I think we would probably need to see a little bit more details, to understand exactly what's being proposed there, so I would encourage you to reach out whichever institute you think this would be Carol Taylor-Burds - NINDS: coming in, and we can clarify that. Tjerignimin Adissa Silue: Thank you. And the following question is for ninds are several diseases included as ftd. Tjerignimin Adissa Silue: Be included as 3 diseases.
Carol Taylor-Burds - NINDS: Right. So this again, it's going to be up to you to define what the disease is. Why, you're separating them as different diseases. Right? We know. Certainly in the neuroscience space, there's a lot going on with, how do we do a biological definition versus the clinical definition. So you really want to put in how you're defining it, why, you're defining it that way and justify it, and then reviewers will comment if they think it's appropriate or not. Senthil Gounder | NINDS: Okay, there is one more question Senthil Gounder | NINDS: or or the devices that Co conduct both monitoring and the therapeutic action in the scope. Carol Taylor-Burds - NINDS: So you can't have, and I know I ran through the exclusion criteria pretty quickly, so you can't have a clinical trial if the trial is to develop a therapeutic. Carol Taylor-Burds - NINDS: So if you're just looking at the monitoring aspect, but you're using the device that's already being given as part of standard of care. Carol Taylor-Burds - NINDS: And you're just looking at the data that you're analyzing from that device, collecting from that device and using it for Carol Taylor-Burds - NINDS: monitoring, that would be acceptable.
Carol Taylor-Burds - NINDS: But if you have any questions again, I think some of these get very nuanced. So if you have any doubt, I really encourage you to put together, draft aims, page, or a little description of the project, and then reach out. We can kind of talk through it more. Tjerignimin Adissa Silue: For now that's all the questions that we have. We encourage everybody to please submit the questions in the chat. Carol Taylor-Burds - NINDS: And I know we had a raised hand a minute ago. Carol Taylor-Burds - NINDS: If you want to ask your question, live feel free to raise your hand, and we can move to that now. Carol Taylor-Burds - NINDS: otherwise we'll just give it a few minutes. Yep, go ahead. Andrew Geronimo: Sorry I didn't. I didn't want to type the whole thing out. But, I want to know about the will. We be dinged for biomarker not being comprehensive for a disease. Because I think we've gotten that feedback before.
Andrew Geronimo: We're not addressing all the aspects of a disease or condition. If we have something very specific, like Andrew Geronimo: speech, but it doesn't address any of the motor changes that occur in the disease. Will will that be a negative. Carol Taylor-Burds - NINDS: So this is why the context of use is so important Carol Taylor-Burds - NINDS: because you really want reviewers to understand. What is it you're trying to measure. Why is that not being captured with the other assessments? This is when we say, you know, is it complementary to existing assessments? Or is it a replacement. So if this is something that's adding in. Carol Taylor-Burds - NINDS: you know, you're capturing something that can't be captured. Normally, you know, you want to make that clear to reviewers, what's the need? And why is this important to be able to measure? Carol Taylor-Burds - NINDS: Does that answer your question? Andrew Geronimo: Yeah, yeah, I have a follow. I have another question, though, and that's house
Andrew Geronimo: when we're considering different diseases and conditions. Andrew Geronimo: can our biomarker of, say, speech, for example, be a, you know, can it differ? In terms of exactly what it's measuring in in different neurological populations, for example, or do you want the Andrew Geronimo: specific outcome to be exactly the same across conditions? Carol Taylor-Burds - NINDS: Right? No, it's a good question. So we're thinking in terms of what's the concept of interest? What's the aspect of the disease that you're trying diseases that you're trying to capture. You're trying to look for standardized ones. Carol Taylor-Burds - NINDS: Right? There are a lot of shared concepts that are important to multiple diseases. Carol Taylor-Burds - NINDS: How exactly they're measured. This is going to help you aggregate some of that data and understand, do they change at different rates? Is there Carol Taylor-Burds - NINDS: disease specific aspects that you might be able to compare across these different disease populations. But you're still trying to measure that same concept of interest in 3 or more disease areas?
Carol Taylor-Burds - NINDS: Does that make sense. Andrew Geronimo: I think so. Yeah. Carol Taylor-Burds - NINDS: And and again feel free to put together an aims page. And it's always easier to kind of talk this through Carol Taylor-Burds - NINDS: and a little bit more detail. If
Carol Taylor-Burds - NINDS: it's it gets a little bit nuanced. Andrew Geronimo: Okay. Thank you. TELEPHONE_USER: Carol. Can I add to that? Just to clarify? TELEPHONE_USER: This is again, this is monitoring, and it's also sort of endpoints and outcome assessments. So we would imagine that the TELEPHONE_USER: some of these measures across diseases would generally perform the same. Say sleep, because that you're just using it for monitoring versus if you were using as a therapeutic, which is why that is excluded from this funding opportunity. We're focusing specifically on this window of biomarkers and endpoints. Carol Taylor-Burds - NINDS: Yeah, thanks, Dan, important. And again, you know, we want to emphasize, we are encouraging collaboration. Right? So these are going to be
Carol Taylor-Burds - NINDS: larger teams because of the different disease areas. Carol Taylor-Burds - NINDS: So really looking for you to reach out to other groups with shared interests and try to put proposals Carol Taylor-Burds - NINDS: together and come in together. Tjerignimin Adissa Silue: We do have a a comment in the chat, and I'm not sure if you can comment on it is, how many application do you anticipate it to be funded. Carol Taylor-Burds - NINDS: Right. So we all know that right now we don't know what the budget is, and that it is a fiscally challenging time.
Carol Taylor-Burds - NINDS: So we don't know the answer to that at this point. Carol Taylor-Burds - NINDS: and we will stay tuned and see what happens. Carol Taylor-Burds - NINDS: So yeah, that's all I can. All I can add for right now.
Carol Taylor-Burds - NINDS: and we'll give it just a couple more minutes if people are thinking about questions. Otherwise we can always end a little early, and people can get a few minutes before their next meeting. Radoslav Raychev: I have a question. Sorry. It probably pertains to a similar question asked before about Radoslav Raychev: specific biomarkers and disease process. So is it Radoslav Raychev: expected this could be neurologic, specific biomarker, it could be Radoslav Raychev: any biomark, let's say, heart rate, or Radoslav Raychev: or glucose, or or is it preferred to be a neurologic specific biomarker. Carol Taylor-Burds - NINDS: So it's gonna depend on your context of use, your Carol Taylor-Burds - NINDS: patient populations. How are you going to use it? What's what is it you're trying to capture with those markers. Why is it important for the diseases that you're including?
Carol Taylor-Burds - NINDS: Right? That's really, again, how is it going to be used? And why is it important? Carol Taylor-Burds - NINDS: And then, of course, it also depends on which populations you're targeting. So Carol Taylor-Burds - NINDS: we have Nci on here. We have nia, so we're going beyond just the neurological as long as it's within one of the other participating institute missions. Radoslav Raychev: Thank you. Carol Taylor-Burds - NINDS: And one other thing I'll just add. So we are going to be posting the slides, and these will be sent out to everyone. We do have some links to some other
Carol Taylor-Burds - NINDS: information. And this is just going to be for people's awareness. There's some resources, not any particular endorsement, but other information that people can explore if they're sort of thinking about what they want to do or looking for, what else is going on in their areas. Carol Taylor-Burds - NINDS: All right. Carol Taylor-Burds - NINDS: I think that might be Carol Taylor-Burds - NINDS: all wrap hopefully. That was helpful for everyone. I really want to thank all my colleagues again for participating in this.
Carol Taylor-Burds - NINDS: and we're looking forward to hearing from all of you. Rakonda Medley: Thank you. Everyone. Happy holidays have a good afternoon.
2024-12-14 23:15
