Wearables, Sensors, and Apps Part 2 – Development and Qualification of Digital Health Technologies in Drug and Biological Product Development

August 29, 2023By Adrienne R. Lenz, Principal Medical Device Regulation Expert

Following up on our first post discussing Digital Health Technologies (DHTs) (here), this post will focus on development and qualification of DHTs for use in clinical trials for drug development.  Earlier this year, FDA hosted a public meeting, Understanding Priorities for the Use of Digital Health Technologies to Support Clinical Trials for Drug Development and Review, intended to bring together key stakeholders, such as patients, biopharmaceutical companies, DHT companies, clinicians, and academics, to understand the priorities for the development of DHTs for use in clinical trials.

Verification and validation of DHTs for use in clinical trials were topics on the minds of many, based on the questions raised by participants during the public meeting.   The draft guidance Digital Health Technologies for Remote Data Acquisition in Clinical Investigations (which we previously blogged on here) includes information on selection, verification, validation, and usability of DHTs and was referenced frequently in responses to participant questions.

It was noted that while there is a goal for consumer level usability, a lot is riding on the data generated by these devices, so there is also a need for rigorous development and validation of DHTs.  At the same time, it was noted that a perspective similar to CDRH’s approach to software as a medical device (SaMD) is desired, so that some of the verification can be done at the sensor level and used across studies, and tools for clinical care and clinical trials can have similar standards for data quality.

Considerations for verification and validation that were discussed included the level of accuracy needed between the DHT and the “gold standard,” as well as sources of variability.  It was also emphasized that DHTs need to be validated in the context of their use and be shown to be fit for purpose.  For example, studies using actigraphy in various disease areas, including Parkinson’s Disease, Atopic Dermatitis, and Heart Failure, were discussed and it was apparent that, while the underlying sensors may be similar, the specific information to be evaluated would vary and, therefore, validation in each population would be important.  It was also noted that validation studies should include normal participants as there is not extensive historical data on what “normal” looks like, given that the use of DHTs in studies is still relatively new.

As many individuals are already users of wearables and have mobile devices, there is a desire from the patient perspective to be able to use their own devices, which they are comfortable using, and to avoid the hassle of having two devices throughout a trial.  While desirable for patients, validation on multiple platforms can lead to challenges.  Identification of technical specifications for underlying hardware or a “white list” of hardware specifications may be an approach that could demonstrate interoperability between DHTs and hardware, allowing a bring-your-own option for some clinical trials. However, being fit for purpose must also be considered; while it might be acceptable to have multiple device types used for a natural history endpoint, studies using sensors to collect data for primary endpoints, e.g., for comparing drug A to B or placebo, may need more consistency to ensure data quality is sufficient for analysis.

If a DHT is a medical device, a common question is whether or not an IDE is needed to use the DHT in a clinical trial of a new drug.  FDA clarified that a medical device used as a DHT in a clinical study of a new drug would not need an IDE if is being used in accordance with its intended use, if its use is considered a non-significant risk, or if its use is considered a significant risk and necessary information to support the use is included in the IND.  It was noted that FDA’s digital health inbox (digitalhealth@fda.hhs.gov), managed by the Digital Health Center of Excellence, could be used to get questions answered on the regulatory status of a DHT used in a clinical trial.

Our takeaway from the public meeting with respect to development and qualification of DHTs for use in drug and biologic clinical trials is to carefully consider the patient’s perspective in light of the requirements for the DHT that are related to the study design and the data to be collected.  A systematic approach similar to that used in development of SaMD (including, for example, design controls) is recommended.