• Include these codes as defined in http://ncicb.nci.nih.gov/xml/owl/EVS/Thesaurus.owl version 📦1.0.0-ballot2

  Code	Display	Definition
  C54721	Early Phase 1 Trial	Exploratory clinical trials, in a small number of participants, that are conducted early in Phase 1. The investigational trial intervention is administered at a low dose for a limited time. Early Phase 1 trials provide insights into a variety of parameters such as pharmacokinetic, pharmacodynamic, and other biomarkers. They involve limited human exposure, have no therapeutic or diagnostic intent, and are not intended to assess clinical tolerability.
  C15600	Phase I Trial	Exploratory clinical trials that may be first-in-human, conducted in a small number of patients or healthy volunteers to evaluate clinical safety, tolerability, or therapeutic intent (pharmacokinetics and pharmacodynamics) of an investigational trial intervention.
  C15693	Phase I/II Trial	A single clinical trial that combines elements of Phase 1 and Phase 2 trials, which may begin as a Phase 1 trial and transition into Phase 2 based upon predetermined criteria.
  C198366	Phase I/II/III Trial	A study that begins as a Phase I study and transitions into Phases II and III based upon successful completion of each previous portion.
  C198367	Phase I/III Trial	A study that begins as a Phase I study and transitions into a Phase III study upon successful completion of the Phase I portion.
  C15601	Phase II Trial	Exploratory trials conducted to evaluate the safety and efficacy of the investigational trial intervention in patients with the disease or condition. Objectives may include, but are not limited to, clinical pharmacology, dose-ranging (dose-response, frequency of dosing), type of patients, or other characteristics of safety and efficacy.
  C15694	Phase II/III Trial	A type of clinical study that combines elements characteristic of traditional Phase II and Phase III trials.
  C217024	Phase II/III/IV Trial	A study that begins as a Phase II study and transitions into Phases III and IV based upon successful completion of each previous portion.
  C15602	Phase III Trial	Confirmatory trials conducted to demonstrate safety, efficacy and tolerability of the investigational trial intervention in patients with the disease or condition. Their objectives are to evaluate the overall benefit-risk relationship and may provide substantial evidence for regulatory approval and product information.
  C217025	Phase III/IV Trial	A type of clinical study that combines elements characteristic of traditional Phase III and Phase IV trials.
  C15603	Phase IV Trial	Post-approval (or post-marketing) trials conducted to further evaluate the safety and efficacy of an investigational trial intervention in its approved indication and may be conducted to address a regulatory requirement. These studies may explore use of the investigational trial intervention in the real-world setting of clinical practice and may also inform health economics and health technology assessments.

Expansion performed internally based on codesystem Fragment of NCIT Code System v1.0.0-ballot2 (CodeSystem)

This value set contains 11 concepts