How decentralized study execution holds in a underserved, repurposing-stage population: lessons from the ReMEdi study in ME/CFS
Repurposing programs run on tighter operational margins than first-in-class assets. The commercial profile rarely supports a conventional site footprint, and the indications that draw repurposing interest (rare, neglected, or underserved) are often the ones the site-based model isn't built to reach efficiently. Decentralized models look promising on paper, but the operational question is whether they hold up in execution, particularly when data completeness can erode the further you move from a clinic. ReMEdi ran fully decentralized in ME/CFS, a population where the most severely affected patients are routinely excluded from research. This panel discussion walks through what that meant in practice for recruitment, retention, and remote endpoint capture in a Phase 2 repurposing study.
In this panel, 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
- Operational proof points on recruitment timelines, retention, and data completeness when you move away from site-based models, with ReMEdi-specific benchmarks shared where available
- Practical design principles for remote and hybrid study designs that maintain regulatory-grade rigor in repurposing programs targeting underserved indications
- A framework for selecting and integrating digital endpoints and wearables, including when continuous monitoring earns its place alongside patient-reported outcomes
- How operational decisions translate into program economics, with particular relevance for repurposing contexts where cost discipline is structural rather than optional
Register here
Meet the panel
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