Significant advancements have been made in the usage and capabilities of Digital Health Technologies (DHT). DHTs are defined as an electronic method, system, product, or process that generates, stores, displays, processes and/or uses data within a healthcare setting. Please visit the EFPIA website or FDA website for more information. The ability to collect data remotely and, if needed, continuously vs. conducting intermittent trial visits, advancements in analytical methods, process enhancements to increase patient adherence, and transparency in the verification and validation of DHTs are all paving the way for using DHTs in clinical trial data submitted to regulatory and health authorities.
The large amount of data generated by DHTs can vary greatly. DHTs can be used as diagnostic, therapeutic, or surrogate endpoints. Implementing data standards throughout the clinical trial lifecycle facilitates data that is Findable, Accessible, Interoperable and Reusable (FAIR) and has the potential to accelerate clinical research. Developing recommendations for the storage and analysis of data from DHTs will improve integration of these data into the CDISC standards environment.
Goals and Objectives
The goal of the CDISC DHT sub-team is to develop standards for data generated from various digital health solutions (wearables, smartphones, applications, patches, etc). Our goal includes best practices for representing digital endpoints and its associated metadata (i.e., device data) in the SDTM format. Project scope will include examples of measurements from passive monitoring and active tests, and will incorporate Controlled Terminology and associated Codetable Mapping files for DHT data. In addition, the sub-team will collaborate with other initiatives (e.g., DEEP).
- Identifying domain(s) for the most commonly generated measurements from passive monitoring and active tests
- Defining Controlled Terminologies and Codetable Mapping Files for the most commonly used digital endpoints
- Adapting SDTMIG for Medical Devices to accommodate DHT needs
- Collaborating with cross-industrial DHT initiatives
- Releasing the first draft for Public Review
- Expanding the controlled terminologies and Codetable Mapping for the most commonly used and validated features
- Incorporating HL7 FHIR potentials
- Identifying potential needs for future CDISC standards development
How to Participate
The DHT sub-team seeks dedicated volunteers to provide expertise for this exciting and fast-evolving new project.
- Essential Skills:
○ A CDISC standards practitioner. Solid implementation experience with SEND, SDTM, and/or ADaM
○ Medical devices expert
○ QRS domain expert
- “Plus” Skills
○ Some familiarity with FHIR/HL7
○ Data science experience with DHTs
○ A member of an organizational standards council or governance body
- Time Period: Six-month commitment, or longer if able
- Hours per week: 4 to 6 hours, including meetings
- Weekly Meetings and Workshops: Recorded and available for review
If you would like to participate in this exciting project, please complete our Volunteer Form. and indicate DHT on the form as the Standards Development team.