Digital Health Framework
ISCTM Digital Health Tool Evaluation Framework
About the ISCTM Digital Health Working Group
Since 2023, an interdisciplinary team of sponsor representatives, digital tool developers, and digital measurement experts has convened as a Sub-Group of the ISCTM Working Group on Digital Measurement. The gap identified was a lack of operational evaluation criteria for factors critical to successful implementation of DHTs into trials, exclusive of issues addressed in the FDA guidance, those under purview of quality assurance teams and any qualification processes to ensure the tool is compliant with local regulations. Two working session were held at the ISCTM 2023 & 2024 Scientific Meetings, with collaborative follow up over the intervening and subsequent months.
About the draft Digital Health Technology Evaluation Framework
The resulting work product is an Evaluation Framework to guide sponsors in assessing DHTs by:
(1) Identifying key product features of DHTs critical to their clinical trial success and
(2) Describing the range of potential experience on identified features to aid in selection and facilitate further DHT development.
This document is available for download below and has been developed to support clinical operations teams in their assessment of digital health technologies intended for deployment in clinical trials or beyond. Its focus is on the operational implications of deploying the technology, rather than its scientific validity or regulatory compliance, or whether a digital health technology is fit for the clinically meaningful purpose that the sponsor is evaluating.
The document is intended to facilitate dialogue during the DHT evaluation process: (1) internally at sponsor companies about the pros and cons of various platforms, and (2) between sponsors and technology partners.
How can you use the Framework?
1. Download the Framework
2. Use it within your organization
3. Return to this site to provide your feedback (optional)
Download the ISCTM Fall 2024 Poster
Download the Digital Health Tool Evaluation Framework
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