Across neurology, cardiology, respiratory, and psychiatry, the technology to measure what matters most to patients already exists. What's missing is the shared evidence, scientific consensus, and regulatory alignment needed to put it to work.
Ametris is launching a bold expansion of DECODE into new indications with unmet measurement need: Amyotrophic Lateral Sclerosis (ALS), Chronic Obstructive Pulmonary Disease (COPD), Heart Failure/Cardiomyopathy, Sleep Disorders, Depression, Schizophrenia, and Parkinson's Disease.
This is more than seven new projects, but rather a coordinated, pre-competitive effort to close measurement gaps that no single sponsor or technology provider can close alone. By uniting pharmaceutical and biotech partners, clinicians, regulators, and patients around each shared challenge, DECODE builds the validated, patient-centered digital measurement tools that accelerate the adoption of digital health technologies (DHTs) across clinical development, moving treatments closer to the patients waiting for them.
Each initiative begins with a measurement challenge that limits how confidently we can detect meaningful change for patients. Here's the opportunity within each:
Neurology
Clinic-based functional assessments are infrequent and physically demanding for patients with progressive mobility loss, often missing meaningful change between visits. Continuous, sensor-based digital measures could capture disease trajectory with greater sensitivity — and far less burden on patients and caregivers.
Respiratory
Exacerbations often go undetected until a patient reaches crisis, narrowing the window for early intervention in clinical research. Wearable and remote respiratory monitoring could surface objective, real-world signals of decline long before the next scheduled visit.
Cardiology
Subtle shifts in cardiac function and functional capacity are easy to miss between episodic clinical assessments, delaying detection of both decline and treatment benefit. Continuous digital measures of activity and cardiac signals could provide the ongoing window into disease trajectory that today's visit-based model cannot.
Sleep disorders
Polysomnography remains the gold standard for assessing sleep, but it is costly, burdensome, and impractical to repeat over time. A validated, wearable-based sleep measure could make continuous, real-world sleep data a routine part of clinical evidence generation.
Psychiatry
Patient-reported outcomes remain central to depression research, yet they are collected episodically and are subject to recall bias. Passive digital measures of behavior and activity could complement traditional assessments with objective, continuous signals of symptom change.
Psychiatry
Cognitive and functional change can be difficult to detect through periodic clinical assessment alone, particularly between visits in a notoriously heterogeneous condition. Digital measures of speech, activity, and social engagement offer a path toward more sensitive, continuous assessment.
Neurology
Motor fluctuations can vary hour to hour — a pattern infrequent in-clinic exams are structurally unable to capture. Continuous, sensor-based measures of tremor, gait, and dyskinesia could reveal the full picture of disease fluctuation and treatment response.
These seven initiatives extend a model that's already working. DECODE's active initiatives are already turning shared measurement challenges into validated, regulatory-ready digital measures across oncology, dermatology, and metabolic disease.
Established with the Digital Medicine Society (DiMe) and leading oncology and immunology sponsors, DECODE CRS is building the evidence needed to safely expand outpatient access to CAR-T and T-cell engager immunotherapies by standardizing how Cytokine Release Syndrome is detected and managed.
Partners:
Digital Medicine Society (DiMe), Boehringer Ingelheim
Building on DiMe's foundational research, this initiative is verifying and validating a wearable-based digital measure of nocturnal scratching to advance research in atopic dermatitis, psoriasis, and similar dermatological conditions by capturing the itch-scratch cycle that disrupts patients' sleep and quality of life.
Partners:
Johnson & Johnson Innovative Medicine, Takeda, UCB, IQVIA
Founded with partners Novo Nordisk and Eli Lilly, DECODE Obesity is developing validated digital measures that capture the functional and behavioral dimensions of treatment response, going beyond the scale to reflect what really changes for patients.
Partners:
Roche, Novo Nordisk, Eli Lilly, AstraZeneca, AbbVie
Pool resources to address evidence gaps too costly or complex for any single organization to solve alone.
Co-design workstreams and share deliverables with fellow working-group members.
Engage regulators early to build consensus on methodology, evidence expectations, and context of use.
Gain an early start evaluating and implementing validated digital measures in your own programs.
DECODE initiatives are already underway with leading sponsors and scientific partners across oncology, dermatology, and metabolic disease.
