The Importance of Precise Scientific Communication: Nonrandomized Trials Should Not Be Described as Phase 3, and Registrational-intent Trials Should Not Be Described as Phase 2.

Inman, Brant A; Vickers, Andrew J · Eur Urol · 2025

expert_opinion · Level V

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Abstract

Standardized nomenclature for clinical trials is required so that the terms phase 1 (first-in-human dose-finding trials), phase 2 (trials to determine the safety and efficacy of a drug and the value of further research), and phase 3 (randomized trials against a standard of care) reflect the actual study design in question.

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