Decentralized study execution in difficult-to-reach populations with remote-capturable endpoints: lessons from the ReMEdi study in ME/CFS
The two structural conditions that make decentralized execution viable are a population that is genuinely hard to reach in a site-based model, and a set of clinical and safety endpoints that can be captured remotely. ReMEdi ran fully decentralized in ME/CFS, a population that meets both criteria: patients with mobility limitations, episodic symptoms, and geographic dispersion, with endpoints captured through ePRO, telehealth, and wearables rather than imaging or biopsy. This panel discussion walks through what that meant in practice for recruitment, retention, and remote endpoint capture, and how to assess whether your own indication is a candidate.
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
- A framework for assessing whether your indication is a candidate for full or hybrid decentralization, based on population reach and endpoint structure
- Operational proof points on recruitment timelines, retention, and data completeness in a fully decentralized model, with ReMEdi-specific benchmarks shared where available
- Transferable learnings across indications with structurally hard-to-reach populations (fatigue-related, CNS, pain, rare disease, Long COVID) and remote-capturable endpoints
- Practical design principles for remote and hybrid study designs that maintain regulatory-grade rigor
Register here
Meet the panel
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