Phase II clinical trials

Phase II Clinical Trials

Phase II clinical trials (pronunciation: /feɪz tuː klɪnɪkəl traɪəlz/) are a critical part of the drug development process in biomedical research. They are designed to assess the efficacy and side effects of a new intervention or treatment in a larger group of people than Phase I trials.

Etymology

The term "Phase II" comes from the sequential nature of clinical trials, following Phase I. The term "clinical trial" originates from the Latin word "clinicus", meaning bedridden, and the English word "trial", meaning a test of the performance, qualities, or suitability of someone or something.

Description

Phase II clinical trials are conducted on a group of patients (usually 100-300) who have the condition that the new treatment is intended to treat. The main purpose of Phase II trials is to determine the dosage that will be used in Phase III trials, and to further evaluate the treatment's safety and effectiveness.

Phase II trials are often randomized controlled trials, meaning that patients are randomly assigned to receive either the new treatment or a placebo or standard treatment. This helps to ensure that any differences in outcomes are due to the treatment itself and not other factors.