Understanding Digital Health Technologies (DHTs) in Clinical Trials

Jan 2, 2024 | News |

Understanding Digital Health Technologies (DHTs) in Clinical TrialsDigital health technologies (DHTs) are becoming more prevalent in clinical investigations and having the correct knowledge on how to utilize these technologies is essential if you choose to implement them. 

On December 21, 2023, FDA released the final guidance document entitled “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations,” draft guidance from December 2021.  

This guidance provides recommendations for those involved in clinical trials on how to best utilize digital health technologies (DHTs) that are fit-for-purpose for remote data acquisition throughout the course of a clinical trial. DHTs have the potential to allow sponsors to run decentralized trials, possibly with more diverse or underrepresented patients that would not have access or consented to participate in a traditional clinical trial. When assessing which DHT is most suitable to use in a specific clinical trial, both the clinical trial population and the minimum technical/performance specifications must be determined. The design of the DHT should also be included in the consideration, as the design can impact how or if the trial population uses the technology based on the DHT difficulty. In some cases, the subjects can use their own DHT or technology (such as an Apple watch) since they are more familiar with it. However, bringing your own DHT should not be a barrier to enter the study as the Sponsors should consider providing DHTs for the study. 

Despite what piece of DHT is proposed to be used within a clinical trial, a description of why the DHT is fit-for-purpose in the context of that trial must be included in the regulatory submission to FDA. The submission must also include a clear description of data flow from initial collection to the first durable electronic data repository, or database, which needs to be maintained until the end of the record retention period and cannot be altered. Verification and validation activities must be performed to prove that the chosen DHT is fit-for-purpose for the trial. A list of potential verification and validation activities is provided within the guidance. Submissions should also include a description of the endpoint(s) collected through a DHT or multiple DHTs as well as the statistical analysis plan that addresses how the data collected from a DHT is analyzed. DHT updates or changes can lead to lapses in data collected that can affect analysis, thus a discrepancies log should be maintained for each DHT. After any updates or changes, it is the sponsors responsibility to ensure the DHT remains fit-for-purpose.  

A glossary and two appendices are provided at the end of the guidance document. Appendix A and B provide examples of potential DHTs and justifications for DHT selections in clinical trials, respectively. To read the finalized guidance from FDA, click below.  

Guidance for Industry (fda.gov) 

Are you planning on designing a clinical trial that utilizes one or more DHTs but are unsure where to start? MEDIcept has an experienced clinical department that can help design and manage your next clinical trial. Reach out to sales@medicept.com to learn more about how MEDIcept can support your clinical trial in 2024!


Guidance for Industry (fda.gov) 

Emily Sawtell – Associate Consultant