Clinical Trials - Phase II

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Written by Vanessa Jones, B.A  | Medically Reviewed by Dr. Sunil Shroff, MBBS, MS, FRCS (UK), D. Urol (Lond) on Aug 28, 2014
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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.

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

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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