It is no secret that the productivity of clinical development has been challenged by the effectiveness of existing endpoints, especially in rare diseases. The ability of sensor-based digital health technologies (DHTs) to “provide a broader picture of how participants feel or function in their daily lives” offers insights that are impossible with established tools but are fundamental to how the agency evaluates the efficacy and safety of new medical products. Better yet, they could also increase trial access and “potentially enable the inclusion of diverse and underrepresented populations.”
How to use DHTs?
The guidance clarifies that the agency expects in a regulatory submission –
✅ How the DHT is fit-for-purpose for use in the clinical investigation
✅ Descriptions of the endpoint(s)
✅ Risk considerations with DHT use, including clinical and privacy-related risks
✅ Training material and operational guidance
✅ Data management plan, including collection, storage, transmission, and archiving
What constitutes “fit-for-purpose" is a key focus during the regulatory engagements in our experience. The submission is expected to include evidence supporting verification, validation and usability of the DHT – the sponsors can leverage evidence from the literature and prior submissions if available.
Again, the agency notes here DHT data could be used for both COA and Biomarker -- and they demand different types of justification and evidence. While this guidance discusses that such justification is needed in the submission, the specifics are beyond the scope of this guidance – the sponsors should refer to other established guidances dedicated to those topics. In particular, the use as COAs will need to follow the FDA Patient-Focused Drug Development Guidance Series.
Ultimately, digital health is still a nascent field. Rather than absolute statements, the FDA left room for the study team to make their own judgements. This is welcome given that DHT use in clinical research is still evolving. Here are my thoughts on the best practices –
Source data is discussed, but the definition is broad. Ultimately the sponsor is responsible for demonstrating the accuracy and traceability of DHT-derived data. We continue to advocate that retention of high frequency raw data from sensor-based DHTs is the most robust and future-proof path forward.
The definition of “device” is out of this guidance’s scope, and the agency suggests that in most cases medical device clearances are not required. On the other hand, as the sponsor is responsible for the performance, safety, and effectiveness of DHT devices, the burden of such proof can often be reduced significantly in the presence of medical device clearance.
The ability to manage software updates during the trial is emphasized in several sections of the guidance, as failure to do so could result in potential alterations of data and measures mid-trial. Transparency from the DHT provider in this regard is important for the sponsor to manage and track this aspect of DHT use.
While the FDA gives examples of consumer devices, it’s likely dedicated device(s) and platform(s) for clinical research will be necessary in the foreseeable future, especially in phase I-III trials, given the FDA’s requirements outlined in the guidance.
We have a practical guide for clinical researchers that breaks down the FDA’s final guidance on DHT use in clinical investigations, which includes a checklist to help study teams navigate the relevant considerations when evaluating if a sensor-based DHT is fit-for-purpose and considerations when evaluating clinical endpoints from DHT data.
ActiGraph has supported many trial sponsors in engagements discussing DHT use in clinical trials with the FDA. We look forward to more in the future, as this guidance release signifies FDA acknowledgement of DHT value and the increasing use of them in clinical trials.
To learn more about using wearable digital health technology in your clinical trial, reach out to your ActiGraph account manager orcontact ustoday.