In December 2021, FDA issued draft guidance, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, which provides guidance for clinical trial sponsors, investigators and other interested parties on using DHTs to acquire data remotely during clinical trials. The guidance provides recommendations intended to facilitate the appropriate use of DHTs in clinical trials evaluating medical devices and drugs.
On February 10, 2022, the FDA’s Small Business and Industry Assistance unit hosted a webinar during which the FDA provided an overview of the draft guidance, clarified the agency’s position regarding the use of DHTs during clinical trials and answered questions from stakeholders. The FDA is soliciting comments on the draft guidance until March 22, 2022.
Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations
A DHT is “a system that uses computing platforms, connectivity, software, and/or sensors, for healthcare and other related uses.” DHTs span a broad range of portable instruments, both hardware and software, that generate clinical measurements (e.g., glucose levels). DHTs, which often run on general-purpose computing platforms (e.g., a mobile phone or smart watch), may be useful in clinical trials to record data directly from study subjects and to collect a broad array of information that provides a better picture of how patients feel or function in their daily lives.
DHTs used in a clinical trial must be suitable, or fit-for-purpose (i.e., the level of validation associated with the DHT must be sufficient to support its use by study subjects and interpretability in the clinical trial). Sponsors should consider the following when assessing whether the DHT is fit-for-purpose:
- whether the clinical event or characteristic of the disease or condition of interest lends itself to measurement by DHTs;
- the proposed trial population’s adoption of, and ability to use, the technology (e.g., education, language, age and characteristics of the DHT) as directed in the protocol;
- the design of the clinical trial (e.g., ease of use may influence whether study subjects will use the DHTs for the duration of the clinical trial and in the manner described in the protocol)1; and
- whether the participants’ own DHTs or other general-purpose computing platform (e.g., mobile phone) may be appropriate to reliably collect or facilitate the collection of data during the trial.
Sponsors should also complete verification and validation analysis. A verification analysis should confirm that the selected DHT accurately and precisely measures its intended physical parameter (temperature, pressure, etc.) over time.2 A validation analysis should confirm that the selected DHT “appropriately assesses the clinical event or characteristic in the proposed participant population.”3 If an endpoint measured by a DHT is novel, a sponsor should endeavor to justify use of that endpoint.
Additionally, sponsors are advised to consider study subject risks associated with use of the DHTs, including clinical risks (e.g., evaluate the physical features of the DHT for risk of injury) and privacy-related risks (e.g., potential disclosure of identifiable information via a breach of the DHT or general-purpose computing platform). Sponsors are advised to ensure the informed consent process addresses the use of a DHT in a clinical trial. And, sponsors are encouraged to ensure study subjects and personnel are trained on using DHTs and, as applicable, general-purpose computing platforms.
The February 10, 2022, FDA webinar clarified and expanded upon key aspects of the draft guidance document. In particular, the Q&A session provided insight into the agency’s thinking regarding the use of DHTs during a clinical trial, including:
- whether marketing authorizations are required for DHTs that are medical devices intended only for use in clinical trials;
- recommendations for engaging with the agency regarding the use of a DHT during a clinical trial;
- appropriate considerations for selecting a DHT;
- appropriate use of a patient’s own DHT or computing platform during the clinical trial;
- verification, validation and usability studies;
- evaluation of the interoperability of a DHT to ensure the secure transmission of data and intended performance of electronic interfaces;
- considerations for selecting clinical trial endpoints;
- informed consent and risks to study subjects when using DHTs; and
- recommendations for handling DHT updates and changes during the clinical trial.
- FDA Draft Guidance for Industry, Digital Health Technologies (DHTs) for Remote Data Acquisition in Clinical Investigations, at 6.
- Id. at 9.