Data from digital health technologies (DHT), including wearable sensors like Apple Watch, Whoop, Oura Ring, and Fitbit, are increasingly being used in biomedical research. Research and development of DHT-related devices, platforms, and applications is happening rapidly and with significant private-...
2021年,美国FDA发布的关于“临床研究中远程数据采集的数字健康技术”(“Digital Health Technologies for Remote Data Acquisition in Clinical Investigations”)的指南草案,被视为一个具有标志性意义的事件。 该指南提供了从使用DHTs的终点收集到临床试验中DHT的验...
Digital health technologies (DHTs) have brought several significant improvements to clinical trials, enabling real-world data collection outside of the traditional clinical context and more patient-centered approaches. DHTs, such as wearables, allow the collection of unique personal data at home over ...
in addition to providing benefits such as optimizing patient overall health status, improving clinician effectiveness and efficiency, lowering overall healthcare system costs, and providing public health and data science benefits2. DHTs that are regulated as, or function alongside, ...
In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” This framework goes ...
3:25 pm Digital Health Technology (DHT)-Derived Physical Activity and Performance in Cancer Cachexia Carrie A. Northcott, PhD, Head of Digital Sciences, Biomeasures, Endpoints and Study Technologies (BEST), Pfizer Cachexia is prevalent across cancer types and results in weight loss, muscle wastin...
DHT data can be extracted and aggregated at different levels of granularity. For example, the raw signal can be aggregated at the epoch-level (e.g. minute-level), or it could be aggregated at a coarser day- or week-level. See Appendix2for an illustration of the hierarchical structure of...
Digital health technologies and drug reimbursement As digital health technologies (DHTs) or "wearables" continue to advance, there are key considerations for drug sponsors to consider to ensure that the data generated by DHTs are acceptable to payers. ...
Digital biomarkers are critical in the analysis of patient data. Clinical ink delivers best-in-class Digital Biomarkers Technology for clinical trials.
Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered onClinicalTrials.govfor four chronic neurological ...