Phase II clinical trial
Phase II clinical trials are a part of the clinical research process focused on the effectiveness and side effects of a drug or treatment. They are typically conducted after Phase I clinical trials, which primarily assess the safety of the drug or treatment.
Overview[edit | edit source]
Phase II clinical trials are designed to evaluate the effectiveness and side effects of a new drug or treatment in a larger group of people than Phase I trials. These trials are often randomized and controlled, meaning that some participants receive the new treatment while others receive a placebo or standard treatment for comparison. The main goal of Phase II trials is to determine if the new treatment has an effect on the disease or condition being studied and to gather additional information about its safety and side effects.
Design[edit | edit source]
Phase II trials are typically designed as randomized controlled trials, with participants randomly assigned to receive either the new treatment or a control treatment. This design helps to reduce bias and ensure that any differences observed between the groups are due to the treatment rather than other factors.
In some cases, Phase II trials may be designed as single-arm studies, where all participants receive the new treatment. This design is often used when it would not be ethical or practical to use a placebo or standard treatment as a control.
Outcomes[edit | edit source]
The primary outcome of a Phase II trial is usually the response to the treatment, such as a reduction in symptoms or an improvement in survival. Secondary outcomes may include side effects, quality of life, and other measures of the treatment's impact.
Follow-up[edit | edit source]
If a Phase II trial shows that the new treatment is effective and has acceptable side effects, it may move on to a Phase III clinical trial. This is a larger study that compares the new treatment to the current standard treatment in a larger group of people.
See also[edit | edit source]
- Clinical trial
- Phase I clinical trial
- Phase III clinical trial
- Drug development
- Randomized controlled trial
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References[edit | edit source]
External links[edit | edit source]
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