In this episode, we explore the transformation of clinical trials through digital endpoints and connected sensors. Traditionally reliant on sporadic hospital visits and subjective self-reports, medical studies are now being enriched with continuous, ultra-precise data captured in the patient's daily life. From the long journey of regulatory validation with the FDA and EMA to the importance of Design Thinking in creating solutions that patients actually want to wear, this conversation highlights how technology is bridging the gap between the clinic and reality, while significantly reducing the burden on participants and their caregivers.

Topics covered:

• The limitations of traditional clinical trials and how digital endpoints bring objective precision.

• The complex, long-term pathway (sometimes taking over a decade) to get a new digital measurement accepted by regulatory bodies.

• A concrete case study: measuring stride and walking metrics in Duchenne Muscular Dystrophy.

• Shifting the mindset regarding the FDA and EMA: moving from fear to an open, collaborative dialogue.

• Data safety and device validation: why consumer-grade wearables aren't ready for official clinical data collection.

• The unexpected parallels between running a Formula 1 team and managing a clinical trial (teamwork, passion, and continuous innovation).

• Using Design Coaching and user-centric processes to design digital tools tailored to patients' and doctors' real needs.

• Future outlooks: reducing the required sample size for trials, leveraging telemedicine, and lowering the logistical burden on caregivers.

Credits :

Production : MedShake Studio

Animation : Anca Petre

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