Clinical Trials - Phase II

Creator: Vanessa Jones
Keywords: effectiveness of drug , experimental drug , new drug ,controlled studies, Phase -II studies,

Written by - Vanessa Jones, B.A

Medically Reviewed by - Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond)

Last Updated on Aug 28, 2014

Clinical Trials - Phase II

In this phase the effectiveness and safety of the experimental study drug or treatment is evaluated by controlled studies. The study drug or experimental treatment is tested on a larger group of people ( 100- 300) compared to a phase I study. This second phase of testing may last from several months to two years.

Since this phase of the study is designed to see if the drug works, patients are given the highest dose that does not cause severe side effects (determined from the phase I study) and are closely observed.

Phase -II studies also help determine, risks associated with the drug as well as short term side effects. Based on the efficacy or toxic effects of the drug / treatment in a Phase -II trial the outcome of the development process could be decided, i.e if a Phase -III trial would be required.

Published on Aug 18, 2014
Last Updated on Aug 28, 2014

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Comments

jagan1206 - Jan 07, 2015

can any one give me different names given to different phases in clinical studies?

infoalcpl - Oct 29, 2010

My colleagues and I have just concluded one of India's most in-depth studies on "Clinical Trials in India". We have looked at various areas such as:
- Market Trends
- Growth Drivers
- Regulatory Bodies and Framework
- Major Players.
-Etc.
We interviewed over 200 individuals and firms to collect the data in what we believe is one of the most detailed study on the subject in India.

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