Regulatory spotlight
We offer selected excerpts from relevant guidances and other FDA materials below, to help you get oriented and understand their significance. It is your responsibility to fully examine and interrogate FDA guidances in detail. Click through on individual resource links to be taken to the primary source material.
Remote data acquisition
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations
There is a need for comprehensive validation and verification processes for DHTs.
Ensuring data security and privacy is a significant concern.
Usability issues for diverse populations need to be addressed.
There is a lack of clarity on whether certain DHTs meet the definition of a device under the FD&C Act.
The guidance does not establish legally enforceable responsibilities.
Recommendations
Ensure DHTs are fit-for-purpose for clinical investigations.
Implement robust data security measures to protect participant information.
Conduct usability evaluations to ensure DHTs can be used by intended populations.
Engage with FDA early to discuss the use of DHTs in clinical investigations.
Develop a risk management plan to address potential issues with DHT use.
Regulatory Considerations
Verification and validation should be addressed regardless of device classification.
Sponsors should ensure compliance with data protection and privacy regulations.
FDA evaluates DHT data based on endpoints, medical products, and patient populations. Sponsors can engage with FDA’s Q-Submission Program for feedback on DHT usage in clinical trials.
Sponsors should understand the legal implications of using DHTs in clinical investigations.
The guidance provides recommendations but does not establish legally enforceable responsibilities.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“In choosing an appropriate DHT, sponsors should consider the clinical event or characteristic of the disease or condition of interest that is to be measured, identify appropriate technical and performance specifications of a DHT, and consider the proposed trial population who will be using the DHT. In addition, sponsors should consider the design of the clinical investigation, and the characteristics of the DHT that may influence trial participant use (e.g., the design of its user interface).”
– Section IV.A (Selection of a Digital Health Technology and Rationale for Use in a Clinical Investigation), p. 8–9, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“The design and operation of the DHT and other technologies should be considered to determine if the DHT is fit-for-purpose. DHT design (e.g., material, size, weight, appearance, portability) and ease of use may influence whether trial participants will use the DHT for the duration of the clinical investigation and in the manner described in the protocol. These factors may be particularly important for DHTs that are wearable, where comfort and convenience may influence a trial participant’s ability and willingness to use the DHT for the duration specified in the protocol.”
– Section IV.A.3 (Design and Operation of DHTs and Other Technologies), p. 9, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“To select the appropriate DHT for a clinical investigation, the sponsor should identify the minimum technical and performance specifications of the DHT. If applicable, the sponsor should identify a specific product or products (e.g., model and/or version) that meet the minimum technical and performance specifications for a DHT to remain fit-for-purpose. If new models and/or versions of the DHT or other technologies become available during the trial, the sponsor could consider adding those models and/or versions if they meet the minimum technical and performance specifications.”
– Section IV.A.2 (Technical and Performance Specifications), p. 9, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“Among other characteristics, education, language, age, health/physical condition, and technical aptitude of trial populations should be considered to ensure that trial participants will be able to use the DHT as intended for the purposes of the trial and to facilitate inclusion of diverse populations in whom the product is intended to be used.”
– Section IV.A (Selection of a Digital Health Technology and Rationale for Use in a Clinical Investigation), p. 9, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
“Sponsor-provided DHTs or other technologies to support their operation should be available as an option to ensure that participants who do not bring their own are not excluded from the clinical investigation for that reason. Sponsor-provided telecommunication services should also be made available as needed so that participants who have no or limited access to these services are not excluded from the clinical investigation.”
– Section IV.A.4 (Use of a Participant’s Own DHT and/or Other Technologies), p. 10–11, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations, Final, 2023 (FDA)
Clinical trials with decentralized elements
Conducting Clinical Trials With Decentralized Elements
Coordination challenges with multiple locations in DCTs.
Variability in data collection across decentralized locations and remote tools.
Challenges in implementing certain statistical approaches in DCTs.
Need for DHTs to be accessible and suitable for all trial participants.
Ensuring compliance with local laws and regulations.
Recommendations
Develop clear protocols for integrating decentralized elements into clinical trials, specifying remote and in-person activities.
Use digital health technologies (DHTs) and electronic systems to streamline data acquisition, informed consent, and investigational product tracking.
Provide training for all stakeholders, including trial personnel, local health care providers, and participants, on decentralized processes.
Implement robust safety monitoring plans to address adverse events in decentralized settings.
Ensure compliance with local and international laws governing telehealth, data privacy, and investigational product use.
Regulatory Considerations
Maintain compliance with FDA requirements under 21 CFR parts 312 and 812 for drug and device trials, respectively.
Document all trial activities and data flows in trial protocols and data management plans, ensuring traceability and integrity.
Ensure informed consent processes meet FDA standards and provide clear communication to participants about decentralized trial activities and data handling.
Address investigational product accountability by documenting IP distribution, storage, and return or disposal.
Design electronic systems for decentralized trials to comply with 21 CFR part 11 requirements for data reliability, security, and confidentiality.
Some summaries are generated with the help of a large language model; always view the linked primary source of a resource you are interested in.
“The guidance…Digital Health Technologies for Remote Data Acquisition in Clinical Investigations provides recommendations…[including] selection of DHTs for use in clinical trials; verification, validation, and usability evaluations; use of DHTs to collect data for clinical trial endpoints; training on the use of DHTs; and management of risks related to the use of DHTs in clinical trials.”
– Section III.C (Digital Health Technologies), p. 5, Conducting Clinical Trials With Decentralized Elements, Guidance for Industry, Investigators, and Other Interested Parties, September 2024 (FDA)
“Sponsors should ensure that DHTs used in a DCT are available and suitable for use by all trial participants. When a trial permits participants to use their own DHTs, sponsorprovided DHTs should be available as an option to ensure that participants who do not have a protocol-specified DHT are not excluded from the DCT for that reason (e.g., lower socioeconomic groups who cannot afford the DHT). Sponsor-provided telecommunication services should also be made available as needed so that participants who have no or limited access to these services are not excluded from the clinical investigation.”
– Section III.C (Digital Health Technologies), p. 6, Conducting Clinical Trials With Decentralized Elements, Final, 2024 (FDA)
Once you’ve read the guidances, explore these best practices from the field:
Industry spotlight
Gathers real-world examples, case studies, best practices, and lessons learned from peers and leaders in the field relevant to this section. Use these insights to accelerate your work and avoid common pitfalls.