The term used for the study of pharmaceutical products is known as clinical research. Its a critical branch in the healthcare science study. 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.
In phase one the device and drugs are evaluated for effectiveness and safeness. The main period can usually take months, and it may have healthy volunteers of 30 to 100. The patients that take part in this study are paid, and mostly it may take a longer period of months. It mainly shows how the pharmaceutical drugs and device react to the patients. The study also shows the side effects that may come up once the product is increased regarding dosage. 65% of experimental drugs are usually tested and must undergo that 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. Patients and investigators are blinded so that neither of them know which group is has acquired the experimental drug. This helps the FDA to have the correct details about the new drug.
In phase 3 the unsystematic procedure and blind testing are done to patients who have volunteered. It can take multiple years, and it gives FDA and pharmaceutical companies to have detailed comprehension of the drug or device. When the product passes through this study phase, it can finalize the requirement that is needed for testing. After the completion of the third phase, pharmaceutical companies can request for its approval.
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 companies usually take a more significant part in this last phase. They must be able to compare both the old and new products that have been used in the market. The monitoring of the new product on the impact, and its effectiveness into the consumers. They need also to determine the cost-effectiveness and the drug therapy that was before the new drug that was approved. The phase can be on the device or the drug. The result that are found in the fourth studies can either make the device or drug to be taken out of the pharmaceutical market, this fourth phase is the most important and vital in the study of clinical research.