What is Clinical Research? 

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use.  This is accomplished through clinical trials.

Clinical trials are experiments or observations that are designed to answer specific questions, such as whether a new treatment or device is safe and beneficial to people.  From start to finish, clinical trials are long, careful processes, which can take many years to complete. Clinical trials involving medications and devices start in a laboratory and may include testing the treatment in animals. If a new treatment shows promise it may move to testing in people in the form of a clinical trial.

Clinical trials show us what works and what doesn’t work.  They are the best way to learn and test different options to treat different medical conditions.

Clinical trials are classified according to their phase (I, II, III or IV).

• Phase I trials test an experimental treatment on a small group of 20–100 healthy volunteers or people with a disease/condition to judge its safety and to find the correct drug dosage.
• Phase II trials test an experimental treatment on a group of several hundred people with a disease/condition to judge the efficacy (how well does it work) and side effects of the treatment.
•  Phase III trials test an experimental treatment on a group of several hundred to several thousand volunteers or people with a disease/condition to gather more information about its effectiveness (efficacy) and monitoring of its safety through adverse reactions. If the FDA agrees that the clinical trial results are positive, it will approve the experimental drug or device.
• Phase IV trials test a treatment on a group of several thousand volunteers or people with a disease/condition and may occur after FDA approval. A device or drug's effectiveness and safety are monitored in large, diverse populations. Sometimes, the side effects of a drug may not become clear until more people have taken it over a longer period of time.