From Concept to Validation
Digital health technologies (DHTs) can address critical limitations in the current drug development process, offering innovative solutions to longstanding challenges such as recall/rater bias, ecological validity, lack of patient-centricity, and insufficient sensitivity of traditional outcome measures.
Despite this promise, new technologies like DHTs can be met with hesitancy due to a lack of definitive proof of the value they bring to clinical development programs. However, as more and more ‘early adopters’ begin to integrate DHTs into their clinical trial operations and regulatory bodies acknowledge their usefulness, the narrative is shifting.
In this issue, we share more around the increasing momentum behind DHT adoption that underscores these technologies are not a short-lived trend and will play a pivotal role in shaping the future of drug development.
Crossing the Chasm: Real-World Value Realized from DHTs in Clinical Trials
Read 4 real-world case studies of clinical trials that incorporated DHTs. We assess the aspect of clinical trial design that DHTs impacted and the value this helped clinical trial sponsors realize in these specific use cases.
Navigating the FDA DHT Guidance: Perspectives from Across the Industry
This webinar began with an outline from the FDA of the DHT guidance that serves as a framework for the development, assessment, and implementation of DHTs in clinical trials. The following discussion featuring a diverse, experienced panel touched on the multidisciplinary approach to DHT integration, how the DHT guidance fits into the regulatory landscape, practical advice and resources for developing verification and validation evidence, and more!
Demystifying AI: A Review of the Fundamentals and Applications in Drug Development
The number of regulatory submissions to CDER with AI/ML components increased from one submission in 2016 to 132 submissions in 2021, with the most frequent being for endpoint assessments and biomarker assessments, i.e. digital endpoints using AI-enabled digital health technology.
In this blog, Ali Neishabouri , Head of Data Science at ActiGraph, reviews the history of AI, clarifies key concepts and common questions, and delves into its application using sensor-based wearable data and its use in drug development.
New Reports Added to the Patient-Focused Digital Measures Library
In our Navigating the FDA DHT Guidance roundtable webinar, the panel discussed how when DHTs are used to collect data for a clinical outcome assessment, the FDA's DHT guidance and Patient-Focused Drug Development guidance series should be used in conjunction and are meant to work together.
We've added 5 new full reports to our Patient-Focused Digital Measures Library, where we highlight how digital measures can track aspects of health that are meaningful to patients, in indications such as asthma, cancer cachexia, osteoarthritis, psoriasis, and pulmonary arterial hypertension.
ADDS 2025: Deadlines Approaching
Mark your calendars for the ActiGraph Digital Data Summit 2025, taking place February 10-12 in Pensacola Beach, FL! Sunday, October 27, 2024 is the last day to submit your abstract for the Scientific Poster Session. It is also the last day to register for ADDS 2025 with Early Bird Pricing and save up to 50% off your registration.
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Webinar | Vital Sign Monitoring Using Wearable PPG Technology: From Concept to Validation
October 23rd @12PM ET
In this session of Digital Health Monthly, Mathieu Lemay (CSEM) will present the latest development on PPG and novel measures it enables, and Matthew Patterson, PhD (ActiGraph) will present the results from a clinical validation study performed on those measures captured by the ActiGraph LEAP wearable device.
Join us to learn more about the steps taken to develop and validate cardiac measures such as heart rate and heart rate variability. We'll plan time for Q&A to help answer your questions about integrating this new technology into your research.
Conferences | Connect with the ActiGraph team
4th Annual Clinical Trial Innovation Summit
Oct. 22 | San Francisco, CA. Meet with Digital Endpoint Consultant Richard Kimble during this PanAgora Pharma event to learn more about how digital measures can support more human-centered clinical trials.
Obesity Week
Nov. 3-6 | San Antonio, TX. Set up time with Richard Kimble to discuss how digital measures of physical activity and sleep can support your clinical development program with more precise and robust evidence.
Huntington Study Group
Nov. 7-9 | Cincinatti, OH. Reach out to Digital Endpoint Consultant Michael Philcock to learn more about how continuous, objective data from wearable DHTs can provide a deeper understanding of Huntington disease symptoms.
7th Annual Digital Implementation Summit
Nov. 13th | Cambridge, MA. Don't miss the presentation by Jeremy Wyatt during the Operationalizing Digital Measurement Tools session at this PanAgora Pharma event!
Medidata NEXT
Nov. 13-14 | New York, NY. Visit with ActiGraph team members Sarah Bell and Matt Biggs to get an insider look at our digital health technology solution.