Clinical research is about collecting data that helps to establish the efficacy and safety of a medical device or a drug. The researcher must run trials that the device or drug must pass before it goes into the market. Since it is a trial, it means that some drugs will fail. Testing might take years because after each stage, the results must be approved.
In Miami, clinical research involves human trials, but these come at a later stage after the device or drug has passed the laboratory and animal tests. Researchers must send information to the FDA (Food and Drug Administration) for it to be approved. After approval for human testing, the drug undergoes the following stages:
During this stage, the aim is to determine how safe the device or the drug is. The process takes months and will involve working with between 20 and 100 volunteers. The study looks at how the device or drug in question affects humans. It looks at crucial body processes, including excretion, metabolism, and absorption. The researchers need to know with clarity what side effects the drug has. Over 60% of prescriptions will go through this phase successfully.
This phase is designed to test the drug’s efficacy. It can last up to 24 months depending on the type of drug and will involve hundreds of patients. Most clinical researchers pick the patients randomly and divide them into groups. One group receives the medication on trial, and the other gets a “control” drug, which can be a placebo or a standard drug known to treat the disease. These studies have to be “blind” so that the researchers do not know which patients receive which drug. That way, investigators can compare the results without bias to know how well the drug works. Close to 30% of all experimental medicines will pass this stage.
Tests in this stage are random and blind. They include several thousand people. Since the testing is done on a large scale, it can last for years. It is meant to give both the FDA and the pharmaceutical company a comprehensive understanding of how effective the drug is and to cover the possible reactions to it. 90% of the drugs that make it to this stage will pass. After they do, the FDA approves the drug for marketing.
Tests conducted during this stage are mainly for surveillance. The company will have different objectives ranging from comparing the drug with others on the market to monitoring the effectiveness of the drug in the long term. The idea is to see how the drug affects the quality of the life of the patient. This stage also tests to see how the new drug holds against traditional therapies. A drug can be banned or restricted depending on how it does during this study.
Different research centers will have set guidelines for how one may participate in a clinical trial. Whether you are a patient or a healthy person who is looking to make a buck, one must always be careful before enrolling for a test. Be sure that the reputation of the research lab you consider is solid.