The FDA (Food and Drug Administration) has released comprehensive guidelines outlining considerations for utilizing Digital Health Technologies (DHTs) in clinical investigations. This newly issued guidance, titled "Digital Health Technologies for Remote Data Acquisition in Clinical Investigations," addresses critical aspects that sponsors and stakeholders must evaluate to ensure the suitability and effectiveness of DHTs in clinical settings.
The FDA's guidance emphasizes the need for sponsors to engage with DHT manufacturers or relevant parties to gather essential information supporting the suitability of DHTs for specific clinical investigations. Although sponsors may not have control over the DHT's life cycle processes, they are responsible for ensuring its ongoing suitability throughout its usage in a clinical investigation.
Considerations for Using Digital Health Technologies
1. Selection of a Digital Health Technology
When selecting an appropriate DHT, sponsors need to consider various factors, including:
Clinical Trial Population: Consideration of demographics, health conditions, language, and technical capabilities of participants is crucial to ensure their ability to use the DHT effectively.
Technical Specifications: Identification of minimum technical and performance specifications for the DHT necessary for its intended use in the clinical investigation.
Design and Operation: Evaluation of DHT design elements, ease of use, feedback mechanisms, power requirements, data storage capacity, and operational specifications.
2. Design and Operation of DHTs and Other Technologies
Several key points must be considered regarding the design and operation of DHTs:
User Interface and Design: Factors like comfort, convenience, and user-friendliness influence participant adherence to using wearable DHTs for the study's duration.
Data Transmission and Blinding: Potential impact on participant behavior due to access to data or results from the DHT; consideration for maintaining blinding or masking of data when necessary.
Power and Operational Specifications: Factors such as battery life, data transmission frequency, and storage capacity must align with study protocol requirements to minimize missing data.
Environmental Factors and Cybersecurity: Consideration of environmental influences on DHT performance and implementation of robust safeguards against cybersecurity risks and unauthorized access to data.
3. Use of Participant's Own DHT and/or Other Technologies
Evaluation of allowing participants to use their personal DHTs or technologies they are familiar with:
Advantages and Disadvantages: Weighing the pros and cons of allowing participants to use their DHTs to reduce additional burden versus potential limitations, especially for highly specialized DHTs.
Sponsor-Provided Options: Ensuring availability of sponsor-provided DHTs and telecommunication services for participants without their own devices or limited access.
The FDA's guidance on Digital Health Technologies for Remote Data Acquisition in Clinical Investigations underscores the importance of meticulous consideration in selecting, evaluating, and maintaining the suitability of DHTs throughout clinical studies. Sponsors must address diverse participant needs, technical specifications, usability, data security, and participant access to ensure the successful integration of DHTs in clinical investigations. This guidance provides a crucial framework for stakeholders to navigate the complexities of incorporating DHTs into clinical research effectively.