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The phase II clinical trials aim to check the harmlessness
or degree of effectiveness of those (1 to 3) promising compounds that have successfully completed the previous stages.
Phase II clinical trials are carried out on 100 to 500 patients
suffering from the target disease. The patients are divided
into subgroups so that different tests may be conducted in
parallel fashion. A promising compound is, first of all, tested on a subgroup.
If the response of patients in this subgroup is not in conformity
with the study’s objectives, the trials are immediately
stopped. This phase allows :
- study of the side-effects and risks
associated with short-term use;
- analysis of the compound’s
impact on metabolism;
- optimization of the dosage and
treatment duration.
| Duration: 12 to 24 months
The compounds selected
are tested on 100 to 500 patients. At the end of these
trials, one or two molecules will be tested in phase
III. This phase lasts between
12 and 24 months.
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These tests are documented in compliance with the requirements
of the regulatory authorities. At the end of these trials, 1 or 2 molecules are retained
for phase III clinical testing. |
