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On December 22, 2021, the Food and Drug Administration (FDA) released draft guidelines for sponsors, investigators, and other interested parties on the use of digital health technologies (DHT) to acquire data remotely from participants in clinical surveys. DHTs (such as wearable devices and sensors) are playing a growing role in clinical research, accelerated by the need for decentralized clinical trials and remote patient monitoring during the COVID-19 pandemic. While primarily intended for sponsors of studies using DHTs, the guidelines raise issues that developers and manufacturers of these technologies will want to be aware of, given the ways in which their products might be used in a use case. clinic larger than initially expected. Comments on the draft guidelines are awaited March 23, 2022. The full text of the guidance can be viewed here.

What is DHT?

DHT is defined as a system that uses computer platforms, connectivity, software, and / or sensors, for healthcare and related uses. For example, an app that uses a smartwatch’s sensors to collect heart rate information might be a DHT. DHTs allow data to be transmitted over long distances, increasing the opportunities for patients to participate in trials and to collect patient data more frequently. The guide details some key considerations for study sponsors when using DHT for clinical investigations.

Selection of an appropriate DHT for the clinical investigation

When selecting a DHT for use in a clinical investigation, sponsors should ensure that it is “fit for use” – meaning that the level of validation associated with DHT is sufficient to support its. use and interpretability in the survey. In determining that a DHT is suitable for use, the FDA recommends that sponsors consider:

  • the clinical event or characteristic of the disease / condition being measured

  • the proposed test population, including whether usability studies are needed

  • clinical investigation design

  • characteristics of DHT that may influence trial participants’ use (for example, whether a subject would use DHT for the duration of a trial).

The sponsor should provide an explanation of why DHT is suitable for the clinical study in a pre-market submission (i.e., a request for clearance or 510 (k) approval). The explanation should contain basic information about DHT (e.g. data collected by DHT is carried out.

Technology verification, validation and usability

Verification and validation studies should demonstrate that the event or clinical feature to be assessed (eg, heart rate) is measured consistently and accurately in the study population. The FDA provides the example that a DHT that captures the steps of a healthy participant may not be applicable to participants with Parkinson’s disease, who may have a shuffling gait. Sponsors should take into account the performance specifications of DHT, identify the conditions under which DHT operates reliably (e.g. temperature range), and ensure that different brands of DHT (e.g. smartphone apps ) collect the same data.

Validation studies, including usability studies, should assess the use of DHT in the target population, including comparison of measurements performed by DHT against baseline measurements (e.g., steps counted by DHT versus steps counted per observation), factors that can affect the accuracy or precision of DHT (eg, placement of a wearable sensor on a wrist relative to a hip), physical interference with the measurement, and other factors. The FDA notes that sponsors can take advantage of verification and validation data made available by manufacturers of DHT.

Using DHT to Collect Data for Clinical Parameters

Promoters using DHT to collect clinical parameters must be justified in a pre-marketing application. If a DHT captures a new endpoint, the sponsor should provide information on the relationship between the endpoint and other well-established endpoints and on the reliability of the proposed endpoint. At the same time, an analysis of the data collected from the DHT should be discussed in a statistical analysis plan which, among other things, addresses how missing or erroneous data will be handled, as well as defines and pre-specifies endpoints and data. sources per participant.

Technological risks

Unique privacy risks may arise when DHT is used in a clinical investigation. In particular, the guide recommends that sponsors take into account the risk of potential disclosure of identifiable information through (i) a violation of DHT and (ii) end user license agreements or terms of service that allow the sharing of data with the manufacturer of DHT and / or other third parties. Thus, sponsors must ensure that safeguards are in place to secure the data collected and transmitted by DHT. Although the guidelines also outline considerations for record protection and retention (familiar territory for study sponsors), the use of DHTs may present additional complexities when recording and transmitting this data. For example, the specific data elements and data format collected by DHT, including all relevant associated metadata, may be different from what a study sponsor has dealt with with more traditional medical products.

Implications

In addition to the key considerations above, the guide provides a handful of other considerations as well as appendices with specific examples of how different types of DHT can be incorporated into a clinical investigation. Sponsors using new DHT technology in clinical studies, or collecting new endpoints using DHT, should consider early engagement with the FDA center responsible for the medical product (i.e. – say CDER) to discuss the use of DHT and its specific attributes and performance characteristics, prior to conducting the study. It can save a company valuable time and resources if the FDA disagrees with the proposed DHT or its intended use in the study.

Copyright © 2022, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XII, Number 7