Using Digital Devices to Collect Patient Data in Clinical Trials

Over the last two years, particularly with the disruption caused by the pandemic, the use of digital technologies in health care has increased exponentially. COVID-19 has had a huge global impact on clinical trials from outright trial cancelations to challenges in recruiting participants. Necessary restrictions on travel and physical contact limited research sites’ abilities to conduct on-site activities, such as patient visits, recruitment, consenting, and diagnostic procedures.

An increased focus on decentralized clinical trials, enabled by digital technologies, has raised concerns among investigators and regulators over the balance between benefits to patients and managing risks to them. Concerns about privacy and usability are also part of the public discourse.

The FDA has recently posted draft guidance regarding “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.” The guidance, aimed at investigators, sponsors, and other stakeholders, is available for public comment until March 2022.

The draft guidance primarily addresses the use of digital health technology (DHT) to acquire data remotely. This can include the use of wearable technologies and sensors to monitor patient vital signs, or the use of smartphones for self-reporting. Besides clinical and physiological data, other information collected can include psychological, behavioral, or functional data.

Digital health technologies are not limited to hardware. Software platforms can include electronic patient-report outcomes or clinical outcome assessments. Some clinical trials can include a combination of multiple DHTs.

The following are some of the issues that investigators and research sites should keep in mind when evaluating the use of digital health technologies.

Define technology selection criteria
The FDA advises sponsors to ensure that a DHT is fit-for-purpose. In other words, the DHT should be validated and sufficient to support its use and interpretability in the clinical investigation. Issues to consider include:

  • The proposed trial population and how the technology may influence participation. This includes education, language, age, and digital literacy. Some participants may need DHTs or computing platforms that support large text, bigger buttons, and foreign language translations to allow for inclusion of diverse populations.
  • The design and operation of the DHT should be appropriate for the study participants and their environments. Wearable devices should be comfortable and convenient to ensure participants’ ability to adhere to the protocol. Operational needs include battery life and power supplies, Internet or Wi-Fi access, notifications and alerts in appropriate languages, among others.

Investigators need to evaluate the use of patients’ own devices or computer platforms. There are several advantages and disadvantages to consider. This includes the familiarity of a DHT for a patient and the convenience of using a technology they already have. However, clinical and technical specifications may require a more specialized DHT to ensure precision and accuracy of the data collected.

To ensure that access to participate in trials relying on DHT’s and/or computing platforms is equitable, provisions may also need to be made to make such technology available to potential trial participants who may not have access to such technology on their own.

Validate and verify the technology
The FDA distinguishes the processes of validating and verifying the selected technology to ensure they are “fit for purpose.” Verification ensures that the technology measures accurately and precisely over time. Validation confirms that the technology appropriately assesses the clinical event or characteristic in the proposed participant population.

This initial evaluation process will ensure that the selected DHT appropriately assesses the clinical event or characteristic in the proposed participant population.

Sometimes the DHT manufacturers can provide verification and validation data.

Define clinical endpoints
The protocol should include a description of the clinical endpoints or endpoints measured by the DHT. A precise definition includes the type and timing of assessments, as well as the tools used for the assessments.

Develop a statistical analysis plan
A statistical analysis plan (SAP) supports transparency and reproducibility in research.

Generally, it starts with a description of the data collected during the trial. It provides a comprehensive and detailed description of the strategy, rationale, and statistical techniques to be used to assess the collected data.

Identify and mitigate risks
Sponsors, investigators, and institutional review boards (IRBs) should consider any risks to trial participants associated with use of the DHTs for data collection. These risks can include loss of patient privacy and clinical risks.

Sponsors should address how they will manage or reduce the risk of potential disclosure of identifiable information. This includes understanding end-user license agreements of computing platforms. In some cases the sponsor may need to work with manufacturers to modify the end-use license agreement.

Include risks in informed consent
Informed consent should include a description of the risks, including privacy issues and plans to mitigate such risks. The informed consent process should explain the type of information that will be collected by the DHT and how that information will be used and monitored.

The informed consent process should specify who may have access to data collected through the DHT during or after the clinical investigation, and for how long.

It should also include information about the end-user license agreement or terms of use that may allow DHT manufacturers to gain access to or even share the collected information. End user agreements for software are notoriously lengthy and complex. Investigators must ensure that participants understand the risks.

If trial participants stand to incur additional costs, such as data use charges, as a result of using DHTs or computing platforms this information should also be addressed as part of informed consent.

The use of technology to collect patient data in clinical trials holds a variety of promising benefits. But investigators, sponsors and IRBs should be clear in their understanding of the risks and have detailed plans for addressing them.

Additional resources
The FDA’s Digital Health Center of Excellence provides regulatory advice and support to the FDA’s regulatory review of digital health technology

The Clinical Trials Transformation Initiative has developed a suite of recommendations and resources for the use of digital technologies in decentralized trials.