Digital health technologies (smartphones, smartwatches, and other body-worn sensors) can act as novel tools to aid in the diagnosis and remote objective monitoring of an individual’s disease symptoms, both in clinical care and in research. Nonetheless, such digital health technologies have yet to widely demonstrate value in clinical research due to insufficient data interpretability and lack of regulatory acceptance. Metadata, i.e., data that accompany and describe the primary data, can be utilized to better understand the context of the sensor data and can assist in data management, data sharing, and subsequent data analysis. The need for data and metadata standards for digital health technologies has been raised in academic and industry research communities and has also been noted by regulatory authorities. Therefore, to address this unmet need, we here propose a metadata set that reflects regulatory guidelines and that can serve as a conceptual map to (1) inform researchers on the metadata they should collect in digital health studies, aiming to increase the interpretability and exchangeability of their data, and (2) direct standard development organizations on how to extend their existing standards to incorporate digital health technologies. The proposed metadata set is informed by existing standards pertaining to clinical trials and medical devices, in addition to existing schemas that have supported digital health technology studies. We illustrate this specifically in the context of Parkinson’s disease, as a model for a wide range of other chronic conditions for which remote monitoring would be useful in both care and science. We invite the scientific and clinical research communities to apply the proposed metadata set to ongoing and planned research. Where the proposed metadata fall short, we ask users to contribute to its ongoing revision so that an adequate degree of consensus can be maintained in a rapidly evolving technology landscape.
These websites are extensively used, they promote drug awareness, and they help patients to avoid possible pro-arrhythmic drugs. Visitors find the websites valuable but should note their limitations.
Background:The Multiple Sclerosis Outcome Assessments Consortium (MSOAC) was formed by
the National MS Society to develop improved measures of multiple sclerosis
(MS)-related disability.Objectives:(1) To assess the current literature and available data on functional
performance outcome measures (PerfOs) and (2) to determine suitability of
using PerfOs to quantify MS disability in MS clinical trials.Methods:(1) Identify disability dimensions common in MS; (2) conduct a comprehensive
literature review of measures for those dimensions; (3) develop an MS
Clinical Data Interchange Standards Consortium (CDISC) data standard; (4)
create a database of standardized, pooled clinical trial data; (5) analyze
the pooled data to assess psychometric properties of candidate measures; and
(6) work with regulatory agencies to use the measures as primary or
secondary outcomes in MS clinical trials.Conclusion:Considerable data exist supporting measures of the functional domains
ambulation, manual dexterity, vision, and cognition. A CDISC standard for MS
(http://www.cdisc.org/therapeutic#MS) was published, allowing
pooling of clinical trial data. MSOAC member organizations contributed
clinical data from 16 trials, including 14,370 subjects. Data from
placebo-arm subjects are available to qualified researchers. This
integrated, standardized dataset is being analyzed to support qualification
of disability endpoints by regulatory agencies.
Aiming to emulate the successful accelerated development of HIV/AIDS drugs, the Critical Path Institute (C-Path), in collaboration with the Engelberg Center for Health Care Reform at the Brookings Institution, has formed the Coalition Against Major Diseases (CAMD). Members include 6 nonprofit groups representing patients' interests, 15 leading pharmaceutical companies, the US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), 2 institutes of the National Institutes of Health (NIH)-the National Institute on Aging (NIA) and the National Institute of Neurological Disorders and Stroke (NINDS)-and representatives from academia. The coalition's purpose is to transform the drug development paradigm for neurodegenerative diseases and serve as a model for other major diseases.
The recent failures in Phase III AD studies are not likely due to insufficient cognitive decline in the control groups. A meta-analytic approach using all available data provides a robust understanding of placebo effect, disease progression, and potential interpretation of treatment effects, and offers a useful tool to aid in both trial design and interpretation.
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