FDA Offers Direction on Using Digital Health Solutions to Gather Trial Data Remotely
The FDA has taken a big step forward in guiding sponsors on decentralized trial approaches, issuing draft guidance on using digital health technologies (DHTs) to remotely obtain data from participants in clinical trials.
The 30-page guidance, published near the end of 2021, provides a number of recommendations for selecting DHTs for trials, verifying and validating them, using them to collect data for endpoints and identifying and managing their risks.
Any DHT being considered for a trial should be fit-for-purpose, the agency stressed in the guidance. That means that sponsors should think about the clinical event or characteristic of the disease/condition being measured, the proposed trial population and the design of the trial, as well as the characteristics of the DHT and how they may impact trial participant use. This is to ensure that DHTs don’t actually make trials more difficult for trial participants, sites and sponsors.
Sponsors should also consider whether the participants’ own DHT — such as a commercial activity tracker or continuous glucose monitor — or mobile phone, tablet or smart watch (called “general-purpose computing platforms” in the guidance) could be a reliable means of collecting data during the trial.
The guidance lists, in detail, a number of specific issues to consider when selecting a DHT and justifying its use in a trial. For example, it goes into specifics about the design and operation of the DHT hardware or software. A DHT’s physical design, such as its material, size, weight, appearance and portability, as well as ease of use, can play a big part in whether participants will use the technology for the length of the trial and according to the protocol. These factors may be more significant for wearable DHTs, the guidance advises. Power needs, too, can have an impact on the feasibility of a DHT for data capture and participants’ willingness to use it.
For validating and verifying that a DHT is truly fit-for-purpose for remote data collection, the section starts out explaining that the process may begin with benchtop studies, move on to testing in healthy volunteers and continue in individuals representing the population to be studied in the trial. These studies should include evidence that the clinical event or characteristic to be assessed, such as heart rate or step count, is consistently and appropriately measured. For instance, the guidance notes that a step-capture algorithm used in a DHT for a healthy participant may not work for participants with Parkinson’s. Usability testing should also point out and address any potential errors or issues participants may encounter while using the DHT. Sponsors may also use verification and validation data from the DHT manufacturer itself or other third parties when appropriate.
The guidance’s recommendations address some of the information that sponsors should include in their investigational new drug or investigational device exemption applications or their marketing applications, the FDA noted.
Any comments and suggestions on the guidance should be filed by March 23.
Read the full guidance here: https://bit.ly/3eCk0oZ.