The Wearable Is Not the Workflow: What FDA’s New DHT Push Means for Trial Operations

FDA’s focus is the measurement, not the gadget

FDA’s July funding opportunity is aimed at questions that matter to drug development: how digital measurements compare with traditional assessments, whether novel endpoints can address unmet needs, how continuous data should be evaluated, and whether DHTs can detect early manifestations of chronic disease. That places the emphasis on clinical meaning and data quality rather than novelty. ([fda.gov](https://www.fda.gov/science-research/science-and-research-special-topics/digital-health-technologies-dhts-drug-development?utm_source=openai))

FDA’s existing guidance applies the same logic. A DHT should be fit for its specific purpose, population, and context of use. Selection should account for the disease characteristic being measured, technical performance, protocol design, and participant factors such as age, language, health status, education, physical ability, and technical familiarity. ([fda.gov](https://www.fda.gov/media/155022/download))

This distinction matters during protocol development. A commercially successful wearable is not automatically a suitable clinical trial measurement tool. Likewise, a technically validated device can still fail operationally if the intended population cannot use it consistently or if the study team cannot detect and resolve problems quickly.

Digital feasibility should be completed before site feasibility

Traditional feasibility often asks sites how many eligible patients they can identify, whether the investigator has therapeutic-area experience, and whether the required equipment is available. A DHT-enabled protocol adds another layer: can the intended participants generate usable data for the required duration?

Sponsors should first model the participant’s actual workload. A protocol may replace one clinic visit while adding daily charging, syncing, surveys, wear-time requirements, password management, notifications, and troubleshooting. Those activities need to be evaluated together. Calling the study decentralized does not make the work disappear. It redistributes that work across participants, caregivers, sites, vendors, and sponsor teams.

The device should also be assessed in the intended setting. Heat, humidity, unreliable connectivity, limited data plans, shared phones, physical work, skin sensitivity, and competing caregiver responsibilities can all affect use. FDA specifically directs sponsors to consider power requirements, storage, data transmission, environmental conditions, alerts, network capacity, and the availability of sponsor-provided devices or telecommunications services when needed. ([fda.gov](https://www.fda.gov/media/155022/download))

• How many minutes of active participant effort are required each day and each week?
• Can the device be used comfortably during work, sleep, exercise, bathing, or caregiving?
• Are instructions and support available in the languages participants actually use?
• Does the site have visibility into adherence soon enough to intervene?
• What happens when a participant changes phones, loses connectivity, or travels?

Missing data is often an operating problem before it becomes a statistical problem

DHT protocols can generate large volumes of data, but volume does not guarantee completeness. A battery may go uncharged. Bluetooth may disconnect. An application may stop transmitting after an operating-system update. A participant may remove an uncomfortable sensor or misunderstand an alert. If the site learns about the gap two weeks later, the data may be unrecoverable.

FDA recommends prespecified plans to reduce and address missing data, including automated monitoring, alerts, reminders, run-in periods, and investigator outreach. The agency also calls for procedures covering device errors, loss, damage, replacement, software changes, and alternate data collection where possible. ([fda.gov](https://www.fda.gov/media/155022/download))

Published regulatory analysis similarly notes that battery life, storage capacity, acquisition schedules, participant characteristics, training, and data-transfer methods should be considered when planning for missingness. It also warns that hardware, software, or algorithm changes during a trial may require additional assessment or validation. ([nature.com](https://www.nature.com/articles/s41746-025-01513-5))

Operationally, this means a DHT data review plan should resemble a recruitment funnel or laboratory reconciliation process. Teams need defined thresholds, owners, and response times. A dashboard that displays missing data without generating an actionable workflow is only a reporting tool.

• Define what counts as acceptable wear time or completion before enrollment starts.
• Separate temporary transmission delays from true missing measurements.
• Assign responsibility for reviewing adherence by day, weekend, and holiday.
• Establish escalation thresholds for participant outreach and site notification.
• Track root causes so recurring device, training, or population-level issues can be corrected.

Site responsibilities must be explicit and budgeted

FDA assigns meaningful responsibilities to both sponsors and investigators. Sponsors should develop training, technical-assistance plans, risk-management procedures, safety-monitoring plans, data-transfer controls, and closeout processes. Investigators should help participants understand what is collected, how it will be used, who can access it, and how it will be monitored. Investigators may also need to train participants and review DHT data according to the safety plan. ([fda.gov](https://www.fda.gov/media/155022/download))

Those tasks have direct staffing and budget implications. Device setup can require more than handing over a box. Coordinators may need to create accounts, pair hardware, confirm transmission, document training, contact caregivers, resolve login problems, replace equipment, retrain participants after updates, and reconcile devices at closeout.

The budget should distinguish vendor technical support from site clinical responsibility. A vendor help desk may resolve pairing or password issues, but it cannot assess symptoms, explain protocol requirements, make safety decisions, or document investigator oversight. Sponsors should not assume that a centralized vendor eliminates local work.

• Include setup and test-transmission time in the screening or baseline visit assumptions.
• Budget unscheduled technical contacts and documented retraining.
• Define reimbursement and logistics for device replacement and return.
• Specify whether sites review raw measurements, processed alerts, adherence reports, or all three.
• Clarify coverage expectations outside normal site hours before contracting.

Remote collection can widen access or introduce a new exclusion criterion

DHTs may reduce travel and make studies more accessible to geographically dispersed participants. However, digital requirements can also exclude people who lack compatible phones, stable broadband, private space, technical confidence, or comfort with continuous monitoring. Research on decentralized trials has cautioned that digital approaches can worsen existing inequalities if access barriers are not deliberately addressed. ([pubmed.ncbi.nlm.nih.gov](https://pubmed.ncbi.nlm.nih.gov/39472759/))

Bring-your-own-device models illustrate the tradeoff. Familiar technology may reduce setup burden, but differences in hardware, operating systems, data plans, security settings, and software versions can complicate validation and support. FDA recommends making sponsor-provided technology and telecommunications available when needed so that people are not excluded simply because they do not own suitable equipment. ([fda.gov](https://www.fda.gov/media/155022/download))

Community sites can provide valuable input here because they see how a workflow performs outside a technology demonstration. Language, disability, health literacy, family support, employment patterns, and local connectivity should be considered during design, not treated as exceptions after enrollment begins. Experience from wearable research also shows that high compliance may depend on active onboarding, data monitoring, reminders, and individualized technical support. ([nature.com](https://www.nature.com/articles/s41746-024-01151-3))

A practical readiness test for DHT-enabled protocols

Before final site selection or activation, sponsors and CROs should conduct a short operational simulation with representative site personnel. The test should begin with device receipt and end with data confirmation, troubleshooting, replacement, and closeout. It should include the participant-facing materials, help-desk process, safety alerts, site dashboard, and documentation requirements.

The goal is not to remove every possible failure. It is to identify which failures could affect participant safety, endpoint interpretability, retention, or data integrity, then make ownership visible. Digital trial design is strongest when the technology is treated as part of the protocol’s clinical operating model rather than as a separate vendor workstream.

• Can a coordinator complete setup using only the approved study materials?
• Can the participant confirm that data are transmitting without seeing blinded results?
• Can the site identify a data gap within the protocol’s recovery window?
• Does the help desk know when to transfer an issue back to the investigator?
• Is there a documented path for abnormal measurements and urgent symptoms?
• Can a replacement device be issued without creating duplicate identities or data streams?
• Can the sponsor reconstruct device versions, updates, training, alerts, and interventions during an inspection?