Exploratory Clinical Trial (ECT)

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An Exploratory Clinical Trial (ECT) is a Clinical Trial that is performed prior to dose escalation and safety and tolerability trials.



References

2019

First-in-human (FIH) studies are a subset of exploratory studies, when the ATIMP is the first time translated from non-clinical studies to humans. The design of FIH clinical trials with ATIMPs deserves specific considerations. For example, the extrapolation from non-clinical pharmacodynamic, pharmacokinetic/biodistibution and toxicity data to the human situation may be limited, depending on the relevance of the non-clinical animal model(...)

 Exploratory studies with ATIMPs are often designed as phase I/II trials, combining features of phase I and phase II design. Examples are trials with GTMPs in patients with monogenetic disease, where dose escalation and determination of a recommended dose is followed by an extension phase, to include additional patients on the recommended dose level and to further explore the efficacy of the GTMP. The trial protocol should define the methodology to move from the dose-escalation phase to the extension phase, and how this is captured in a substantial amendment.

2009