Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks. [ https://prsinfo.clinicaltrials.gov/definitions.html ]

This is just here as a test because I lose it

Term information

Subsets

NCIT_C132298, NCIT_C66737, NCIT_C66830, NCIT_C61410, NCIT_C67497

ALT DEFINITION

A study to test whether a new treatment has an anticancer effect (for example, whether it shrinks a tumor or improves blood test results) and whether it works against a certain type of cancer.

Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [after FDA CDER handbook, ICH E8]

Phase 2. Controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. NOTE: Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. [After FDA CDER Handbook, ICH E8] (CDISC glossary)

Contributing Source

CDISC

CDISC-GLOSS

Legacy Concept Name

Phase_II_Trial

Preferred Name

Phase II Trial

Semantic Type

Research Activity

UMLS CUI

C0282460

code

C15601

definition

Includes controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in participants with the disease or condition under study and to determine the common short-term side effects and risks.

A clinical research protocol designed to study a biomedical or behavioral intervention in a larger group of people (several hundred), to evaluate the drug's effectiveness for a particular indication in patients with the disease or condition under study, and to determine the common short-term side effects and risks associated with the intervention.

has exact synonym

Phase II Clinical Trial

Phase II Trial

2

Phase II Study

phase 2

Phase 2 Study

Trial Phase 2

PHASE II TRIAL

phase II trial

Clinical Trials, Phase II

Phase II Protocol

imported from

http://purl.obolibrary.org/obo/ncit.owl

Term relations

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