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Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.

ABSTRACT: The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific and regulatory challenges. To better understand and address these regulatory science gaps, a working group of the Clinical and Translational Science Awards Program convened the Regulatory Science to Advance Precision Medicine Forum focused on digital health, particularly examining gaps in the use, validation, and interpretation of data from sensors that collect and tools that analyze digital biomarkers. The key findings and recommendations provided here emerged from the Forum and include the need to enhance areas related to data standards, data quality and validity, knowledge management, and building trust between all stakeholders.

SUBMITTER: Adamo JE

PROVIDER: S-EPMC7204775 | biostudies-literature | 2020 Jan-Apr

REPOSITORIES: biostudies-literature

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Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.

Adamo Joan E JE Bienvenu Ii Robert V RV Dolz Felipe F Liebman Michael M Nilsen Wendy W Steele Scott J SJ

Digital biomarkers 20200101 1

The proliferation of digital technologies and the application of sophisticated data analysis techniques are increasingly viewed as having the potential to transform translational research and precision medicine. While digital technologies are rapidly applied in innovative ways to develop new diagnostics and therapies, the ultimate approval and adoption of these emerging methods presents several scientific and regulatory challenges. To better understand and address these regulatory science gaps, ...[more]

PMID: 32399511

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Project description:Innovative tools are urgently needed to accelerate the evaluation and subsequent approval of novel treatments that may slow, halt, or reverse the relentless progression of Parkinson disease (PD). Therapies that intervene early in the disease continuum are a priority for the many candidates in the drug development pipeline. There is a paucity of sensitive and objective, yet clinically interpretable, measures that can capture meaningful aspects of the disease. This poses a major challenge for the development of new therapies and is compounded by the considerable heterogeneity in clinical manifestations across patients and the fluctuating nature of many signs and symptoms of PD. Digital health technologies (DHT), such as smartphone applications, wearable sensors, and digital diaries, have the potential to address many of these gaps by enabling the objective, remote, and frequent measurement of PD signs and symptoms in natural living environments. The current climate of the COVID-19 pandemic creates a heightened sense of urgency for effective implementation of such strategies. In order for these technologies to be adopted in drug development studies, a regulatory-aligned consensus on best practices in implementing appropriate technologies, including the collection, processing, and interpretation of digital sensor data, is required. A growing number of collaborative initiatives are being launched to identify effective ways to advance the use of DHT in PD clinical trials. The Critical Path for Parkinson's Consortium of the Critical Path Institute is highlighted as a case example where stakeholders collectively engaged regulatory agencies on the effective use of DHT in PD clinical trials. Global regulatory agencies, including the US Food and Drug Administration and the European Medicines Agency, are encouraging the efficiencies of data-driven engagements through multistakeholder consortia. To this end, we review how the advancement of DHT can be most effectively achieved by aligning knowledge, expertise, and data sharing in ways that maximize efficiencies.

Dataset Information

Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.

Publications

Translation of Digital Health Technologies to Advance Precision Medicine: Informing Regulatory Science.

Similar Datasets

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