Abstract: A clinical trial is a research study that involves human volunteers, on whom the effectiveness of a new drug is tested. In other words, clinical trials are carried out to find out if proposed treatments work on human beings. A clinical trial for a specific new drug takes nearly 910 years to reach the completion stage. It comprises four stages, all of which are closely monitored and evaluated by investigators, physicians, nurses and para-medical staff. These professionals discharge the critical function of recording the data and analysing the same for regulatory purposes. Clinical trials are conducted within the regulatory frameworks of the drug approving countries, such as the US Food and Drug Administration.
A clinical trial for a drug costs anywhere between US$350m and US$500m,which is about 40% to 50% of the total cost of drug development. In the last few years, outsourcing of clinical trials to developing countries such as India has increased steeply due to significant cost and time reduction advantages. No wonder, in the last one year , number of clinical trials taking place in India have more than doubled. |
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