One disease-specific program serving patients, clinicians and sponsors — with real-world evidence generated as a by-product rather than through a separate study.
A patient support program deployed in routine clinical practice, not as research. Because it is a care service, it can launch without ethics committee approval, and consent is written so the data can later support a study through a retrospective submission.
Continuous digital support between visits, with reminders, education, coaching and direct messaging to the physician in one app. Patient-reported outcomes, symptoms and side effects are simple to record.
A clinician dashboard alongside the patient app closes the care loop. Outcome data arrives as a by-product of care and feeds health economics, registries and benchmarking. EHR integration avoids double documentation.
Measurable persistence gains, a regulatory-grade real-world evidence package for market access, and aggregated usage and prescription insight by site and region.
Two conditions have to hold. The program must add value to the care pathway rather than friction. And clinicians are recognized as investigators and co-authors on any study built from the data.
From the patient and prescriber: validated PROMs and quality-of-life scores, daily symptoms, side effects and triggers, medication intake and adherence, prescription and platform usage, and wearable or sensor data.
From the hospital record: demographics and comorbidities, biomarkers and blood tests, clinical scores, treatment history, and real-world effectiveness at follow-up.
Deployed in musculoskeletal, neurology, obesity and immunology programs across Europe, with real-time data sharing to treating physicians.
Not to launch. It is a care service rather than research, deployed in routine clinical practice. But the exemption is narrower than it sounds: it holds only while the data serves care and program monitoring. The moment an analysis is published or submitted as evidence, an ethics opinion is required. For routine-care data that is a lighter, faster retrospective submission — possible only because consent was designed for it up front.
Aggregated, non-individual data. Record-level access runs through a Trusted Third Party rather than going to the sponsor directly.
Yes, provided consent was designed for it at the start. That is the reason the consent design matters before the program launches rather than after.
Yes, in both routes. The care-service route changes the ethics position, not the data protection position.
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