Clinical rigor in fully digital, fully remote study execution: lessons from the ReMEdi study in ME/CFS
Fully digital, fully remote execution puts two clinical questions on the table: whether telehealth-based assessment matches the rigor of in-clinic, and whether any gaps matter for the clinical and regulatory picture. The Phase 2 ReMEdi RCT in ME/CFS tested that directly. Telehealth visits, ePROs, Oura continuous monitoring, and GripAble remote functional testing replaced the in-clinic workflow, in a population the traditional site-based model isn't built to reach. Dr. Beata Godlewska, Principal Investigator at the University of Oxford, joins to discuss how clinical rigor was maintained in practice and what continuous monitoring adds to clinical interpretation.
In this panel discussion, Meri Beckwith, Co-CEO of Lindus, Dr. Simon Bock, Clinical and Market Access, Portfolio & Innovation Manager at Tiefenbacher Group and Dr. Beata Godlewska, Principal Investigator for the ReMEdi trial, sit down to discuss how modern trial design is expanding what's feasible. Drawing on their experience running the ReMEdi study in Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS), they'll discuss how innovative trial design strategies enabled them to capture regulatory-grade data in a population historically excluded from research, how digital endpoints and wearables are providing more granular, remote, and patient-centric data, and how these methodological choices help sponsors work through the operational hurdles that commonly cause programs to stall.
The conversation will also cover the regulatory challenges and economic considerations that shape drug repurposing strategies, including how feasibility and commercial attractiveness factor into development decisions.
What you'll learn
- Where telehealth-based clinical assessment matches in-clinic, and where the differences sit
- What continuous monitoring data adds to (and complicates in) clinical interpretation
- How PI oversight was structured without an in-clinic touchpoint, and what made it hold
- What these clinical-rigor approaches imply for digital innovation programs across underserved indications
Register here
Meet the panel
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