Phase Iii
Posted in Uncategorized on 11/21/2010 11:30 pm by admin
Phase Iii
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Clinical Trails - Phases For Public Safety
Clinical trials are tests conducted to find out the safety and efficacy of drugs before they are launched in the market. Clinical trials are conducted on a small group of people and analyzed to see if there are any adverse reactions to a particular drug. These trials also monitor the effectiveness of drugs.
There are different phases of clinical trials that are closely monitored by regulatory bodies. Almost all pharmaceutical companies and biotechnology firms utilize an efficient Clinical Trials Management System (CTMS) to manage the huge amount of data that clinical trials produce. A quality Clinical Trials Management System helps track, collate and analyze data during clinical trials.
Here are the three different phases of clinical trials:
Phase I:
First test of a new drug for treatment of a particular medical problem. The test is done because the drug has shown some promise of a cure in the laboratory. Tests are done to find out if the treatment is safe. What is the best mode of administration of the treatment? What is the right amount of dosage? The first phase is done on a very limited number of persons.
Phase II:
If the results of phase I suggest that the drug is safe, then the company moves towards the second phase of clinical trials. Here the drug is tested to see if it helps patients. Here the sample size is large and the treatment may be administered to over a hundred patients. Common side-effects of the drug is tracked and analyzed.
Phase III:
In Phase III, the new drug is usually compared to the existing treatment to see if it helps patients better. Studies are done to see if the new drug fares better or worse than the existing ones. Or whether the new drug produces the same results as the old one. The trials are conducted over a large section of patients with half the number of patients receiving the new drugs while the other half receives the old one. The efficacy of the new drug is then studied through comparison. This phase of clinical trials is generally more complex.
The development in Information Technology and the stringent regulations of regulatory authorities have increased the need for quality pharmacovigilance system. These systems help make clinical trials and other drug development processes so much easier and quicker.
About the Author
Pharmacovigilance system helps safeguard public health. A Clinical Trials Management System helps monitor and manage clinical trials efficiently.
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