The term clinical research it’s the study and procedure carried out on pharmaceutical products. 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. So at this study, ones the drugs have been approved by FDA they continue into other phases.
A phase 1 study mostly evaluates the safety of the drug and the devices. 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. The study shows mainly how drugs or devices can react to human beings. It also studies the side effects, in which may occur when the dose is increased in the human body. The pharmaceutical products are mostly tested and need to undergo this first phase.
Phase 2 is to study the ability of both medicine and device used on humans. The study can almost take up to 2years, and it includes many patients. The patients in this phase are divided into two groups. The first group of patients get experimental drug and the second group receives the standard 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.
In phase three it includes blind testing and unsystematic way into thousands of patients. The phase takes a longer period so that the pharmaceutical companies can get the correct details and information about the product. When the product passes through this study phase, it can finalize the requirement that is needed for testing. 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.
Post-marketing is the 4 phase, and its conducted mostly after the drug or device has been approved for the consumers to use. The companies usually take a more significant part in this last phase. They need to compare other drugs and the new drugs that have been in the pharmaceutical market. They also need to monitor the impact and usefulness of the new product into the patient. They need also to determine the cost-effectiveness and the drug therapy that was before the new drug that was approved. 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 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.