There has been an increasing use of digital measures in drug development recently. New wearables technologies can help expand the sources of evidence that we can use to make more reliable treatment decisions. Regulatory bodies across the globe are also beginning to realize the power of such technology in improving clinical research and are developing pathways for qualification of digital technology-based methodologies. For regulatory submissions, the use of wearables technology in a clinical trial requires assembly of an evidence dossier to explain the link between the disease and the measurement ascertained by the wearable, the reliability of the wearable in providing accurate measurements, the functional way in which the wearable will be used to assess various factors, and more.
Below are seven steps that you can follow to create an effective evidence dossier to support the use of wearables in clinical trials.
Step 1: Describe Intended Goal for the Wearable Provide clear and concise description of intended goal for the wearable technology in the context of the clinical trial, including specific endpoint definition(s), where the endpoint will be positioned in the overall endpoint hierarchy, the clinically meaningful aspects of health to be measured, and the targeted labelling claim or other intended regulatory use.
Step 2: Concept of Interest for Measurement It is important to clearly state whether the concept being directly measured is the meaningful aspect of health itself or is a concept that will be measured and shown to have a good relationship to the meaningful aspect of health (i.e. be used as a surrogate measure).
Step 3: Context of Use In this step, the sponsor needs to clearly state how the wearable is intended to be used to assess time, physics, study design. This includes elements such as disease(s) and target population(s), clinical trial design, guidelines for obtaining valid measurements, timing of assessment within a day (e.g., assessed in the morning) or relative to other activities during a day (e.g., not within 1 hour of prior vigorous activity) and duration of assessment at each timepoint of measurement.
Step 4: Content Validity Documentation Content validity means ensuring that the device-derived endpoint has an adequately strong relationship to the intended meaningful aspect of health and is sufficiently comprehensive for the intended claim of benefit. You need more extensive evidence when the endpoint is indirectly measuring the intended meaningful aspect of health, whereas it is easier when the chosen endpoint is measuring this directly.
Step 5: Construct Validity of the Ability to Detect Change Once the device’s content validity has been established, the regulatory bodies consider additional measurement properties for review, i.e., reliability, construct validity, and ability to detect change. This includes providing evidence that the clinical values of the endpoint obtained from the wearable device, as filtered and transformed by the specified algorithms, can be interpreted as the intended concept of interest for measurement (i.e., construct validity) which is equivalent to the use of a reference method. You also need to offer evidence that a sensor-based endpoint can identify differences in scores over time in individuals or groups (like those in the clinical trials) who have changed with respect to the measurement concept.
Step 6: Clinical Interpretation Provide definition of the methods for analyzing the results between groups. Sponsors should define guidelines for the amount of change that can be viewed as minimally, moderately, and highly clinically important to patients.
Step 7: Technology Specific Plans In this final step, you need to detail all means to control data capture and to enable analysis. It is important to provide the critical information describing how patient assessments using the wearable technology will be implemented in a consistent and reliable manner within a clinical trial protocol, and to provide detail on data management and statistical analysis.
To learn more about the regulatory aspects of Wearables Clinical Trials, click below.