Clinical Research
Clinical research is a “healthcare science branch” that determines the safety and effectiveness (efficacy) of medications, devices, diagnostic products, and treatment regimens intended for human use. These may be used for prevention, treatment, diagnosis, or for relieving symptoms of a disease.
Clinical research is different from clinical practice. In clinical practice, established treatments are used, while in clinical research, the evidence is collected to establish a treatment.
Clinical trials are a type of research that studies new tests and treatments and evaluates their effects on human health outcomes. People volunteer to participate in clinical trials to test medical interventions, including drugs, cells and other biological products, surgical procedures, radiological procedures, devices, behavioral treatments, and preventive care.
Clinical trials are carefully designed, reviewed and completed, and need to be approved before starting. People of all ages can take part in clinical trials, including children.
Regulations: Good Clinical Practice and Clinical Trials | FDA
Clinical Trials: What Patients Need to Know | FDA
Phase I trials
These are conducted on a small group of healthy volunteers on whom researchers test an experimental drug or treatment for the first time. The aim is to determine a safe dosage range and identify potential side effects.
Phase II trials
These are conducted on a larger group of people with the condition of interest to see if it is effective and further evaluate its safety.
Phase III trials
They are conducted on a larger group of people with the condition of interest. Researchers confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information to allow the experimental drug or treatment to be used safely. Upon completion of this phase, a new drug can be introduced to the market if approved by the FDA (The Food and Drug Administration).
Phase IV trials
These are conducted after a treatment is approved by the FDA for use. It provides additional information, including the treatment or drug's risks, benefits, and best service. Continuous monitoring of new drugs on the market helps determine efficacy and side effects and the potential withdrawal from the market if deemed necessary.