{"product_id":"9783032404398","title":"Digital Health Technologies for Drug Development Practical Guide","description":"\u003ch1\u003eDigital Health Technologies for Drug Development\u003c\/h1\u003e\u003ch2\u003ePractical Guide\u003c\/h2\u003e\u003ch3\u003eMarta Karas | Junrui Di | Vanja Vlajnic\u003c\/h3\u003e\u003cdiv\u003e\u003cb\u003eMedical \/ Biostatistics\u003c\/b\u003e\u003c\/div\u003e\u003cbr\u003e\u003cdiv\u003e\u003cp\u003eThis book provides the first comprehensive, end-to-end guide to the use of Digital Health Technologies (DHTs) in clinical trials and drug development. DHTs, including wearable sensors and smartphone-based assessments, are transforming the way clinical evidence is generated throughout drug development. By enabling continuous, objective, and patient-centered measurement of physiology, behavior, and real-world functioning, these technologies are redefining clinical endpoints and expanding the possibilities of decentralized and data-driven clinical research. \u003cbr\u003eBringing together contributions from statisticians, clinicians, data scientists, clinical operations leaders, regulatory experts, technology developers, and patients themselves, it follows the complete lifecycle of a digital measure - from identifying clinically meaningful concepts of interest and selecting fit-for-purpose technologies, to analytical validation, clinical validation, regulatory considerations, and implementation in global clinical trials.  \u003cbr\u003eAt its core is an extended treatment of data analysis methods, with chapters on signal processing, functional data analysis, dimensionality reduction and clustering, pattern segmentation, free-living smartphone data, endpoint validation, designs such as N-of-1 studies and micro-randomized trials, and pre-clinical applications. Dedicated chapters address the regulatory landscape, and the volume closes with perspectives from stakeholders across the ecosystem on where the field is heading. \u003cbr\u003eServing as both a practical reference and a methodological guide, this volume is intended for researchers and professionals working in pharmaceutical and biotechnology companies, academia, contract research organizations, regulatory agencies, and digital health technology companies. It equips readers with the scientific, analytical, and operational foundations needed to successfully integrate digital health technologies into modern drug development and ultimately improve patient care.\u003c\/p\u003e\u003c\/div\u003e\u003cdiv\u003e\n\u003cp\u003e\u003cstrong\u003eDr. Marta Karas\u003c\/strong\u003e is a statistician on Takeda's Quantitative Sciences team in Cambridge, MA, with more than ten years of research experience in digital health. She specializes in the study design and statistical analysis of wearable device data in clinical trials, leveraging digital health technologies to improve the measurement of patient outcomes in drug development. She has led statistical analysis of multiple clinical trials in areas such as hypersomnolence disorders, plaque psoriasis, and amyotrophic lateral sclerosis. Her publication record includes methods for preprocessing, aggregating, and segmenting patterns in raw sensor data; resampling methods for sample size estimation; regularization methods for regression; digital technology validation studies; and digital biomarker development and evaluation in clinical studies. Dr. Karas completed postdoctoral training in the Department of Biostatistics at Harvard University and holds a Ph.D. in Biostatistics from Johns Hopkins University and Bachelor's and Master's degrees in Mathematics from Wroclaw University of Science and Technology. Outside of work, she enjoys connecting with people, running, and hiking.\u003c\/p\u003e\r\n\u003cp\u003e\u003cstrong\u003eDr. Junrui Di\u003c\/strong\u003e is an experienced biostatistician and data scientist with a decade of research experience in statistical and machine learning methodologies for digital health technologies. His work focuses on study design and the modeling of high-dimensional, high-frequency data from wearable devices and mobile sensors, particularly for patient-centered and decentralized clinical trials. From 2019 to 2024, he served as a statistical lead at Pfizer Inc., where he advanced digital health solutions across clinical trials and contributed to digital endpoints for atopic dermatitis and heart failure. Since 2024, he has served as lead data scientist at Dexcom Inc., focusing on the development and validation of continuous glucose monitoring technologies. Dr. Di earned his Ph.D. in Biostatistics from Johns Hopkins University, his M.S. in Biostatistics from Georgetown University, and his B.A. in Applied Mathematics from the University of California, Berkeley. Outside of work, he enjoys cooking and music.\u003c\/p\u003e\r\n\u003cp\u003e\u003cstrong\u003eDr. Vanja Vlajnic\u003c\/strong\u003e leads the data science and statistical development programs for several late-stage assets at Bayer. He is the co-lead of the Biostatistics Innovation Center AI group and is highly involved in developing methodologies for the analysis of high-dimensional data in the clinical space. Dr. Vlajnic holds a Ph.D. in Systems Engineering from Colorado State University, a Master’s of Applied Statistics from Penn State University, a Master’s of Experimental Psychology with a focus in Behavioral Neuroscience from Seton Hall University, and an MBA from Boston University. With over 10 years of research experience, he has published in the areas of wearables and biosensors applied to the pharmaceutical space, machine learning applications to clinical data, causal learning and causal inference, clinical assessment tools in schizophrenia, and visual perception. He has been a co-lead of the DIA IDSWG AI subteam, a member of the American Statistical Association, and a member of the Vision Sciences Society.\u003c\/p\u003e\n\u003c\/div\u003e\u003cbr\u003e\u003ctable\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublication Date: \u003c\/td\u003e\n\u003ctd\u003e16 December 2026\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003ePublisher: \u003c\/td\u003e\n\u003ctd\u003eSpringer Nature Switzerland\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eImprint: \u003c\/td\u003e\n\u003ctd\u003eSpringer\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eISBN-13: \u003c\/td\u003e\n\u003ctd\u003e9783032404398\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003ctr\u003e\n\u003ctd\u003eFormat: \u003c\/td\u003e\n\u003ctd\u003eHardback\u003c\/td\u003e\n\u003c\/tr\u003e\n\u003c\/table\u003e","brand":"Springer Nature Switzerland","offers":[{"title":"Default Title","offer_id":53984068173964,"sku":"9783032404398","price":197.99,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/0710\/9545\/1788\/files\/9783032404398.jpg?v=1787748382","url":"https:\/\/lateknightbooks.com\/products\/9783032404398","provider":"Late Knight Books and Services, LLC","version":"1.0","type":"link"}