Scope Study of Clinical Research

The study of pharmaceutical products is mainly known as clinical research. The study mainly takes part as a branch in the study of health science. The products that are used in this study may cure or treat diseases and can be used in surgical procedures. When the drugs are approved by FDA, they are set to be studied in other phases.

At phase one it mainly the evaluation and safeness of the devices and drugs. The main period can usually take months, and it may have healthy volunteers of 30 to 100. Each volunteer is paid for taking part in the study, and it may take a long period of up to several months. The study shows mainly how drugs or devices can react to human beings. Also, it shows the side effects that can occur once the dosage is increased. The pharmaceutical products are mostly tested and need to undergo this first phase.

The ability of both the device and drug are shown in phase two. The study can almost take up to 2years, and it includes many patients. In this group, the volunteers are divided into two groups. The first set of patients usually get the experimental drug while the other set gets the standard experimental treatment. The phase has firm procedures whereby both the investigator and patients don’t know which type of experimental drug has been used in each group. the phase helps the FDA to have correct information about the new product.

The next phase which is 3, it includes unsystematic and blind testing way in thousands of patient who have volunteered. The phase takes a longer period so that the pharmaceutical companies can get the correct details and information about the product. After the drug pass through this stage, they are most likely be able to finish the requirement needed in testing at this phase. When the completion of the third phase is done, the companies can request for the approval of the device or drug in the medicine market.

The fourth phase is the post-marketing, it usually done after the drug or device has been approved by the FDA for consumers to use. The pharmaceutical companies play a more prominent role in this fourth phase. They must be able to compare both the old and new products that have been used in the market. Also, it monitors the effectiveness and the impact of the drug in the patient. The cost-effectiveness is also done at this stage, and it consists of the older drug therapy and the new drug therapy that has been approved by FDA. The results that come out of this stage entirely determine whether the new pharmaceutical products can be removed from the market or to remain. The fourth stage is always vital in clinical research because it shows the actual results of a new product.

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