Clinical trials have always been commonplace in the testing of drugs and new medical procedures and devices so as to ascertain their safety and efficacy and to allow for the improvement of such products before they are deemed fit for use. Initially, testing is usually carried out in the laboratories on human cells and sometimes on animals. Once these initial tests are successful, the data is sent to the Food and Drug Administration (FDA) for approval to carry out the testing on humans. Once the FDA approves the data, research can then be carried on in form of human clinical trials. Human clinical trials typically take place in four phases. Each phase is a separate human clinical trial on its own and once a phase is complete researchers are required to hand in their findings to the FDA for subsequent approval. If the FDA is not satisfied with the results of that particular human clinical trial they could order the phase to be redone or ask for the research to be discontinued. The first phase of human clinical trials aims at determining the effects of the drugs or the device and usually involves a small number of healthy volunteers usually less than 100 and takes several months. In most cases these volunteers are paid to participate in the human clinical trial since they are exposing themselves to a risk (a drug or device that has never been used before on humans). At the end of this phase researchers usually have information on side effects for different dosages, absorption and metabolism rates and how the drug is excreted. These are the safety aspects of the drug. Once the drug is approved as being safe for human use by the FDA, the human clinical trials proceed to the second phase where the efficiency of the drug is tested. In this phase which can last up to two years, the experimental drug is given to one group of patients in the human clinical trial while another control group receives what is known as a placebo or standard treatment. These studies are usually blinded meaning that neither the researchers nor the patients know who is receiving the placebo and who is receiving the experimental drug. This aims at ensuring the objectivity of the data and to reduce chances of researchers interfering with data to gain approval for subsequent phases. Phase three of human clinical trials which is carried on after approval of the phase two data by the FDA carries out research on the effectiveness and safety of the drug but on a wider scale with thousands of patients being tested using the blind testing method. This allows the FDA and pharmaceutical companies to get a larger picture and a more thorough understanding of the drug’s effectiveness. Once this stage of the human clinical trial is passed pharmaceuticals get approval to market the drug. The final phase of human clinical trials is a post marketing surveillance which is conducted on the drug or device. This aims at comparing the drug with other similar drugs in the market, checking its long term usefulness and impact on quality of life and determining its cost effectiveness relative to other treatments.
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Clinical trials have always been commonplace in the testing of drugs and new medical procedures and devices so as to ascertain their safety and efficacy and to allow for the improvement of such products before they are deemed fit for use.
Mary Major is the author of this article on Genome Research. Find more information on Cloning here.
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