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.
expert_opinion · Level V
Where this comes from
- Record sourced from PubMed, PMID 40118738.
- Also identified by DOI 10.1016/j.eururo.2025.03.001.
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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.
Medical subject headings
- Terminology as Topic
- Research Design
- Clinical Trials, Phase III as Topic
- Clinical Trials as Topic
- Clinical Trials, Phase II as Topic