Pharmaceutical clinical trials are research studies that explore whether a medical treatment is safe and work best for certain illnesses or groups of people. These studies follow strict scientific standards to protect patients while producing reliable research results.
Clinical trials are a part of a long and carefully managed process to bring new medicines to the market for patients to use for various acute and chronic medical conditions. The process starts by testing potential treatments in the laboratory, then it may be followed by animal testing, it then goes through a Food & Drug Administration (FDA) controlled clinical trials process of testing with human volunteers to ensure safety and efficacy, before it is made available to patients as either prescription or over-the-counter medication.
The FDA clinical trials process proceeds in four stages. It begins by a small group of healthy volunteers testing the medication, and later a larger group of volunteers that have the targeted medical condition test the medication for risks and benefits. Through this part of the research process, researchers may find that the new medication improves patient outcomes, offers no benefit over currently available treatments (if any), or causes unexpected harm to the patient.
Volunteers involved in clinical trials are referred to as research subjects, or subjects, and their involvement in a study is kept anonymous and confidential.
All of these results are important because they advance medical knowledge and help improve patient care.