For FDA Real-Time Trial Monitoring
Live Clinical Trials, Powered by Objective Hand Data
The FDA's new pilot program will monitor clinical trial data in real time to speed safe approval of new therapies. Digits Health gives sponsors and sites the streaming, structured, regulator-ready hand-function endpoints that real-time monitoring requires.
A new era of real-time trial oversight
The FDA's 2026 pilot lets the agency review trial data as it's collected — instead of waiting for end-of-study filings. Sponsors that can stream high-quality, objective data will move first.
Real-time
Continuous review of incoming trial data, instead of one snapshot at the end of the study.
Faster
The pilot is explicitly aimed at speeding patient access to safe and effective therapies.
Structured
To stream usefully, endpoints must be quantitative, standardized, and audit-ready.
Why traditional hand assessments can't stream
Real-time monitoring assumes the data flowing to the FDA is comparable across sites, days, and raters. Goniometer-based hand assessments rarely are.
Inter-rater variability
Manual goniometry varies by 7–9° between raters — noise that can bury or fake a treatment effect when reviewed in real time.
Site-to-site drift
Different clinics, different rulers, different habits. Multi-site trials accumulate measurement drift the FDA reviewer has to untangle.
Paper-bound workflow
Hand-written ROM values keyed into an EDC days later defeat the entire point of streaming, real-time oversight.
Sparse follow-up
Patients only get measured at scheduled visits, leaving the regulator blind to what happens between them.
How Digits fits the FDA pilot
Digits replaces the goniometer and the paper form with a camera-based, computer-vision pipeline that produces structured, time-stamped, exportable hand-function data — the kind of data real-time review was designed for.
Real-time data flow
Every assessment a participant completes is captured digitally and exportable on demand — no transcription lag between the patient and the regulator.
Objective endpoints
Computer-vision ROM, dexterity, and volume measurements remove inter-rater variability so a trend is a trend, not a rater change.
Decentralized by design
Participants assess at home on any device with a camera. Trials reach more patients, more often, without adding site burden.
Standardized protocol
One assessment script across every site and every visit. The endpoint your statistical analysis plan defined is the endpoint that gets collected.
Audit-ready exports
Structured exports with timestamps, device metadata, and protocol version — ready for an EDC, a sponsor data lake, or an FDA reviewer.
Patient-friendly
A voice-guided, hands-free assessment that takes minutes. Better adherence means denser, more useful data over the trial.
Endpoints validated in peer-reviewed research
Digits' measurements are not a black box. Each endpoint we surface to a clinical trial is supported by published validation studies.
Finger joint ROM
MCP, PIP, and DIP flexion and extension across all digits. Test-retest ICC > 0.75 across joints; AR-based flexion within ~10° of goniometry.
Létourneau et al., J Hand Surg, 2024
Finger dexterity
Remote tapping-based dexterity outcomes validated against the Nine-Hole Pegboard Test, the gold-standard dexterity metric.
Kuchtaruk et al., J Hand Ther, 2024
Hand volume / edema
Webcam-based digital hand volume measurement compared to water displacement and figure-of-eight techniques.
Katouzian et al., J Hand Ther, 2025
From participant to FDA reviewer
A trial-grade pipeline that gets objective hand data into the hands of regulators in hours, not months.
- 1
Participant assesses
Voice-guided protocol on any camera-enabled device, at home or at the clinic.
- 2
Data structured
Computer vision converts video into quantitative endpoints with full metadata.
- 3
Sponsor monitors
Centralized dashboards show site-level adherence, data quality, and emerging trends in real time.
- 4
Regulator streams
Audit-ready exports flow continuously into the EDC and on to FDA real-time review.
Trials Digits is built for
Anywhere a sponsor needs an objective, repeatable measure of hand function across sites and across time.
Inflammatory arthritis
DMARDs, JAK inhibitors, and biologics for rheumatoid arthritis and psoriatic arthritis — quantify joint mobility and dexterity changes between dosing visits.
Osteoarthritis
Symptomatic and disease-modifying OA therapies — track hand-function trajectories across long enrollment periods without flooding sites.
Post-surgical & trauma
Tendon, fracture, and reconstruction studies — measure recovery curves at home rather than at scheduled clinic visits.
Neurology & rehab
Stroke, MS, and Parkinson's trials where dexterity and ROM are sensitive markers of treatment response.
Built with regulated trials in mind
Digits Research Connect is engineered around the controls trial sponsors and regulators already expect.
Standardized protocol
Versioned assessment scripts so every visit captures the same endpoint.
Time-stamped records
Every measurement carries the timestamp, device, and protocol version it was captured under.
Structured exports
CSV / JSON exports designed to drop into EDCs and statistical pipelines.
Multi-site coordination
Centralized dashboards for sponsors and CROs running distributed studies.
Bring Digits into your next live trial
Whether you're preparing a submission to the FDA's real-time monitoring pilot or designing the next generation of decentralized trials, our team can help you wire objective hand assessments into your protocol.