The term clinical research it’s the study and procedure carried out on pharmaceutical products. Moreover, its well known as a branch in the study of health science. Products that are used can cure and relieve diseases and also may be used in the surgical section of the study. So at this study, ones the drugs have been approved by FDA they continue into other phases.
At phase one it mainly the evaluation and safeness of the devices and drugs. The phase also has healthy volunteers. The volunteers are paid in participating in that whole study. It mainly shows how the pharmaceutical drugs and device react to the patients. Also, it shows the side effects that can occur once the dosage is increased. A certain percentage of experimental drugs are mostly tested and must undergo this 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 set of patients usually get the experimental drug while the other set gets the standard experimental treatment. Both the patients and investigators are blinded so that neither can know who has acquired the experimental drug. This helps the FDA to have the correct details about the new drug.
The next phase which is 3, it includes unsystematic and blind testing way in thousands of patient who have volunteered. Under this phase, it’s usually long and can take a more extended period for the pharmaceutical companies to have detail information about the device or drug. Drugs that pass through this stage may be able to finish the requirement of testing in this phase. After the completion of the third phase, pharmaceutical companies can request for its approval.
The last and most crucial phase is the fourth one and it’s known as post-marketing, and its mostly done once the product has been approved by FDA for the use or consumption by consumers. The pharmaceutical companies play a more prominent role in this fourth phase. They need to compare other drugs and the new drugs that have been in the pharmaceutical market. The monitoring of the new product on the impact, and its effectiveness into the consumers. 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 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.