A clinical trial is medical research involving people. There are two main types of clinical trials, observational and interventional.
The purpose of an observational clinical trial is only to collect data from study participants. The participant is not assigned to a particular treatment or any experimental medication or procedure. The data collected may help researchers determine any associations. An example of an observational study is collecting data from a group of smokers and non-smokers. This data is able to show a link between smoking and lung cancer.
The purpose of an interventional study is to determine the safety and effectiveness of a new therapeutic treatment such as a new medication or medical device. Some of the biggest medical breakthroughs over the last century that have become standard practice were first introduced to people through clinical trials.
The U.S. Food and Drug Administration (FDA) must give their approval in order for a clinical trial to begin. Data from laboratory tests and animal studies is reviewed to determine if there is reason to believe that the potential therapy will work as designed while being safe and effective in people. If the benefits of the potential therapy outweigh the risks, the clinical trial may begin.
Patient safety is the number one priority for any clinical research site. Each trial has eligibility criteria to make sure the trial is suitable for that individual. Prior to starting any study procedures, the potential participant goes through the informed consent process, where someone from the study team thoroughly reviews the trial requirements and an individual can make an informed decision about participating in the trial. Study participation is voluntary, and consent can be withdrawn at any point during the trial. If the study participant passes screening and is deemed eligible for the trial, they may start treatment and follow the trial schedule.
A clinical trial goes through different phases of clinical research where data from a set number of participants is analyzed, and if the treatment is deemed safe and effective, it moves along through the next phase. More participants are recruited to gather enough data to determine if the investigational product is safe and effective. The FDA may approve the product after the clinical trials are completed and the product may be introduced to the market and made available as a standard treatment.