FDA releases draft guidance on digital health technologies in clinical trials | McGuireWoods LLP
Recent advances in sensor technology and data transmission methods are expected to benefit clinical trials by facilitating data collection through digital health technologies (DHT). The United States Food and Drug Administration (FDA) defines a DHT as any system that uses computing platforms, connectivity, software, or sensors for healthcare purposes. On December 23, 2021, the FDA released draft guidance to provide recommendations to clinical trial sponsors, investigators, sites, and other interested parties on the use of DHTs to collect data remotely from trial participants. clinical tests.
- DHTs are an emerging tool for clinical trials that facilitate remote data collection.
- The FDA has released draft guidance on the use of DHT in clinical trials, including requirements for DHT-related policies and procedures.
- Sponsors, sites and investigators should carefully consider whether DHTs fit the purpose of the clinical trial. This requires consideration of participant populations, DHT design and usability, and possible use of personal devices (e.g., mobile phones) rather than provider-provided devices. ‘investigator.
- Sponsors, sites, and investigators should analyze DHTs for risks, including clinical risks associated with measurement errors and cybersecurity threats, privacy risks, and license agreements (when using personal devices) that could lead to unwanted data sharing and unique informed consent issues.
- Sponsors, sites, and investigators can manage the risks of using DHTs through proper record retention, training, and policies and procedures that address technical, security, privacy considerations and clinics.
Interested parties should submit comments and suggestions on the FDA’s draft guidance by Wednesday, March 23, 2022.
What is a DHT?
DHTs are systems that use computing platforms, connectivity, software, or sensors for healthcare purposes. This may include hardware, software, or a combination of hardware and software. DHT hardware consists of sensor hardware that facilitates continuous or intermittent recording of physiological or behavioral data. DHT software can provide and administer electronic clinical outcome assessments and reports. For example, a glucometer that collects and transmits data is a DHT.
Additionally, suppose the meter uses software that can be downloaded to participants’ mobile phones, on which participants can rate their perceived functioning each day. In this case, this software is also a DHT. Multiple DHTs can be used simultaneously in a clinical investigation to collect a range of useful information from remote participants.
The value of DHTs is evident when compared to more traditional intermittent test visits. Traditional modes of clinical data aggregation are hampered by the burden of travel to the trial site for participants, especially for participants with physical or cognitive limitations, those with time constraints, or geographically dispersed participants . Remote data collection through DHTs allows for continuous or more frequent data collection from participants, regardless of location or ability. DHTs also enable decentralized clinical trials with larger groups of participants.
The following information details the FDA’s proposed guidelines on the selection of DHTs and the identification and management of risks.
Sponsors, researchers, and sites should consider the following when selecting a suitable DHT for a particular clinical investigation. The ability to validate DHT data should be sufficient to support its use and interpretability in clinical investigation.
- Population. Consider whether the education, language, age, and technical aptitude of clinical trial populations affect reliable results. For example, DHTs may require large text or buttons, translated versions, or other changes to properly relate to the clinical trial population.
- Design and operation. Consider power requirements, data storage, operational specifications, environmental factors, and privacy and security requirements, all of which factor in the DHT to be used for a trial.
- Use of personal device or trial device. Consider whether familiar devices reduce certain loads. In all cases, devices must be technologically aligned and provided to participants who do not already own an eligible device.
The FDA guidelines highlight the following risks associated with the use of DHT in clinical trials that sponsors, researchers, and sites should consider.
- Clinical risks. Analyze DHT for physical characteristics that could cause injury to participants; the risks of measurement error, in particular in situations where the measurements provide feedback on changes in the administration of the products investigated (eg glucometers); and cybersecurity risks that may impact functionality and the secure storage and transmission of data.
- Privacy Risks. Analyze DHTs to detect potential risks of disclosure of protected health information and vulnerabilities to malicious intervention and access. Additionally, determine if general purpose devices such as mobile phones have end user license agreements or terms of service that allow data sharing with manufacturers or other parties.
- Informed consent. As with any clinical investigation, disclose to participants the risks associated with the trial. This is very important when introducing DHT, which carries its own unique risks, into a trial. Investigators should explain to participants the information collected, the measures taken to ensure confidentiality and security, the potential costs related to DHT (for example., mobile phone data charges), and any issues with end user license agreements.
The FDA has proposed the following guidelines to limit the risks associated with the use of DHT.
- Good record keeping. When using DHT to record and transmit data, all data must be transferred and stored securely in a durable electronic data repository. The FDA has previously issued relevant guidance on this in Use of Electronic Records and Electronic Signatures in Clinical Investigations under 21 CFR Part 11 – Questions and Answers (June 2017).
- Coaching. All trial participants and personnel should be trained in the use of the selected DHTs before the trial begins. The training should cover everything from downloading data, connecting networks for transmission, and responding to DHT errors.
- Emergency policies and plans. Ensure appropriate policies are written and planned to protect against the threat of non-compliance with FDA guidelines. Here are the key policies and plans that sponsors and sites should establish before using DHT in clinical trials:
- Technical Support Policies and Procedures.
- Policies and procedures for resolving potential technical, privacy, and clinical issues.
- Security monitoring policies and procedures, specifically addressing abnormal security-related actions.
- DHT Data Logging Policies and Procedures.
- Policies and procedures for replacing and repairing hardware when malware is detected on a DHT.
The recent shift from analog clinical trials to decentralized clinical trials will continue due to the ability of DHTs to leverage varied and continuous data collection. The FDA is the first of many agencies to appreciate the risks posed by such technology in clinical trials. Sponsors, investigators, and sites should carefully consider all risks associated with the use of DHTs and develop policies about them.
As guidance from the FDA and other agencies changes the regulatory landscape, the authors of this article and digital health practice group McGuireWoods are ready to offer guidance. Please contact the authors of this article for more information on how these guidelines, if finalized, will impact clinical trial performance, and what sponsors, investigators, and sites should do to to prepare.