Phase II Trials

Phase II trials are generally the first studies with a new medicine in patients. They are usually conducted in a small number of patients who are monitored closely. These trials are often larger than Phase I trials.

Phase II studies are designed to find out if the medicine has a beneficial effect on the disease in question: They might compare the new medicine to an existing treatment or to a placebo. They also set out to determine the best dose range and how often the medicine should be given, and investigate the best way to manage any side effects.

A new medicine has to meet certain pre-set requirements before it can continue to Phase III trials. Phase I, II, and III trials are commonly known as ‘clinical development’.

: The four phases of clinical development differ in terms of their objectives and features.

Synonyms:

Phase II Study, Phase II Studies, Exploratory

Glossary: Hard Endpoint
Glossary: Phase I Trials
Glossary: Exploratory trials
Statistics in clinical trials: Sample populations
Researchers in clinical trials select sample populations from the whole patient population that the trial applies to, as it is not possible to run the clinical trial in the whole patient population. This is a standard statistical producedure. There are many things to consider in the selection of a sample population
Non-clinical development: Types of non-clinical study
There are several types of non-clinical study, each with its own objectives and specific requirements for completion.

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Phase II Trials

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