Remote Monitoring in Clinical Trials During the COVID-19 Pandemic

A Decision Framework for Moving Clinical Assessments Out of the Clinic

When the COVID-19 pandemic disrupted in-clinic visits industry-wide, pharmaceutical sponsors were forced to rapidly rethink how clinical trial data gets collected, with little established playbook for doing so at scale. A paper published in Clinical and Translational Science, authored by Koneksa Health’s Elena Izmailova, Robert Ellis, and Christopher Benko, addresses the questions sponsors faced head-on: which assessments can move to remote collection, how do you know they’re still valid, and what does that shift mean for regulatory compliance?

What the Paper Proposes

• A decision tree for migration: The authors propose a structured decision tree to guide the migration of clinic-based assessments to remote collection, rather than leaving that decision to ad hoc judgment calls under pandemic pressure.
• Validity as a gating requirement: The framework treats validity, safety, and usability as non-negotiable checkpoints; an assessment doesn’t move to remote collection just because it’s technically feasible to do so.
• Regulatory implications addressed directly: The paper explicitly considers what moving an assessment to a remote or decentralized model means for regulatory acceptability, not just operational continuity.
• A response born of necessity, built for durability: While written in response to an acute crisis, the framework was designed to hold up beyond it, as a general approach to clinic-to-remote migration decisions in any circumstance, not just a pandemic.

Why This Still Matters for Trial Design Today

This paper captures a turning point in how the industry thinks about trial design: remote and decentralized data collection stopped being an emerging idea and became an operational necessity almost overnight. The decision framework proposed here, evaluating each assessment’s validity, safety, and regulatory fit before migrating it out of the clinic, remains directly applicable to any sponsor building a decentralized or hybrid trial today, pandemic or not.

This is the same rigor Koneksa Health applies when helping sponsors decide which endpoints are ready to move to remote or continuous collection, and which still require in-clinic oversight.

Reference: Izmailova ES, Ellis R, Benko C. Remote Monitoring in Clinical Trials During the COVID-19 Pandemic. Clin Transl Sci. 2020;13(5):838-841. doi:10.1111/cts.12834. PMID: 32526077.