On December 22, 2023, the U.S. Food and Drug Administration (FDA) released final guidance for industry, investigators, and other stakeholders entitled, “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The guidance provides recommendations on the use of digital health technologies (DHTs) for remote data capture from clinical trial participants and defines DHT as “a system that uses computing platforms, connectivity, software, and/or sensors, for health care and related uses.” This definition includes hardware such as wearables, sensors and eCOA computing platforms and their associated software applications.
Trial sponsors using DHT according to the recommendations in this final guidance may facilitate clinical trial efficiency. Trial objectives may be accomplished with smaller sample sizes (and reduced cost) because DHT’s dense, continuous, objective data on the participants’ functional ability throughout their daily lives is likely to provide a much richer picture of the participant’s ability than his/her own verbal reports or an observer’s perceptions collected on only a few occasions at study visits.
Further, remote data capture via DHTs is likely to make trial participation more convenient (al a hybrid or decentralized clinical trials) and may provide opportunities for individuals who are unable to participate in traditional trials due to inability to travel or other limitations that may result in underrepresentation and potential bias.
Digital health technologies (DHTs) promote many benefits, including increased diversity, equity and inclusion, improved clinical trial efficiency, and enhanced data quality.
The following previews the issues outlined in the guidance to help sponsors ensure their selected DHT is “fit-for-purpose”:
Considerations for selecting a DHT and rationale for use
The guidance discusses considerations for choosing a DHT including the parameter to be measured, the DHT’s technical specifications and usability, and the trial population and design. Detailed considerations are outlined pertaining to the clinical trial population, DHT specs, design, and operation, as well as for use of a participant’s own DHT, i.e., Bring Your Own Device (BYOD).
DHT description in a submission
In a submission, the sponsor should describe how the DHT is fit-for-purpose, including (but not limited to):
DHT verification, validation, and usability evaluations
Sponsors are advised to conduct these evaluations, which may involve a series of studies from benchtop through those with patients from the target population and should demonstrate that the DHT accurately and precisely measures its intended parameter(s) in the population of interest. Usability testing may be conducted to identify challenges that trial participants may experience when using the DHT and interoperability evaluation should be considered to ensure connected systems effectively and securely exchange information and that the data are interpreted appropriately.
Evaluation of endpoints involving DHT data
The submission should include a description of the DHT-acquired endpoint(s). The guidance outlines considerations for defining the endpoint as well as for handling both established and novel endpoints.
Trial design and statistical analysis considerations
The guidance outlines considerations for appropriate DHT trial design including thoughts on non-inferiority designs and recommendations to ensure a robust statistical analysis plan.
DHT risk considerations
Sponsors should consider both clinical and security risks of DHTs that may need to be assessed by the IRB and included in a submission. These risks should also be described in the informed consent document, and the guidance outlines considerations for the DHT-related information to include in the informed consent process.
Record protection and retention
Clinical trial data acquired via DHT should be securely transferred to and retained in a durable electronic data repository as part of the record of the clinical investigation. The guidance outlines recommendations when planning for investigational trial record retention.
Other DHT considerations
The guidance outlines additional recommendations pertaining to roles of sponsors and investigators, as well as for training and cases of DHT updates and data loss or other errors to help ensure data quality and integrity, participant protection, and satisfaction of regulatory requirements.
YPrime’s digital health technologies include eConsent, eCOA, and IRT. Please visit www.yprime.com to learn more about them or contact us for more information about using YPrime’s technology platform in your upcoming clinical trial.
REFERENCE
Digital Health Technologies for Remote Data Acquisition in Clinical Investigations. Guidance for Industry, Investigators, and Other Stakeholders. [Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations] (Accessed Jan 15, 2024)