When a new drug is developed, its safety and effectiveness must be tested before it can be introduced into the medical marketplace and given to patients. North America and Europe used to be at the centre of clinical trials, but the last decade has seen a considerable increase in the number of clinical trials being conducted in developing countries such as India and China. These countries provide pharmaceutical companies with large numbers of volunteers, and the time taken to complete clinical trials is usually much shorter. However, there is growing concern that vulnerable people may be exploited by pharmaceutical companies. Some people claim that the basic rights of volunteers may be neglected in the interest of making research more convenient, efficient and cheaper. This Bioethics considers the ethical implications of testing new drugs, with specific reference to populations vulnerable to exploitation.
Clinical trials are carried out to test the safety and effectiveness of new drugs and vaccines. Such trials are divided into four phases and with each consecutive phase the number of volunteers (research subjects) increases (see Figure 1).
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