What is a clinical/medical research study?
Before an investigational medication can be approved as a treatment for a specific illness or disease, researchers must prove that the investigational medication is safe and that it works. They do this by testing the investigational medication in many research studies. These are also called clinical trials, clinical studies, or clinical research studies. Even after a medicine is “approved” for doctors to prescribe, clinical research studies can continue to be conducted to increase understanding about how a particular medicine can be most effectively used by doctors. The medicine being investigated in a clinical research study is called an “investigational medicine”. Without clinical studies, new medications cannot be developed.
Why do people participate in clinical research studies?
People participate in clinical research studies for various reasons including:
- Gaining access to investigational medical treatments that may not be otherwise available
- Helping researchers understand if and how an investigational medications works and why
- Helping others in the future who have the same illness or disease
What are the different phases of clinical research?
Clinical research studies are traditionally divided into four phases. Each phase is designed to gather specific information about the study drug or treatment.
In preclinical development, also named preclinical studies or nonclinical studies, is a stage of research that begins before clinical trials (testing in humans) can begin, and during which important feasibility, iterative testing and drug safety data are collected. The main goals of pre-clinical studies are to determine the safe dose for first-in-man study and assess a product's safety profile. Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.