A clinical study (sometimes called a clinical research study, trial, or protocol) is a way to determine appropriate dosing of new medications and use of medical devices as well as ensure they are safe and effective. Medications being researched for safety and effectiveness are known as investigational drugs or study drugs. Clinical trials involve the testing of these new investigational drugs or medical devices in phases that allow doctors and researchers to obtain reliable information about the drug or device and, at the same time, protects the patient.
Treatment trials test new treatments and may include new medications, therapies, devices or approaches to surgery.
Diagnostic studies are conducted to find new tests or procedures for diagnosing certain diseases or conditions.
Screening studies focus on the absolute best ways to detect certain diseases or conditions.
Quality of life trials looks at how different factors, including treatment, affect the quality of life for individuals living with specific diseases or conditions being studied.
Prevention studies test ways to decrease or prevent diseases or conditions from developing or getting worse. These studies may include medicines, vitamins, or other lifestyle modifications.
Phase I studies test a new investigational drug on humans for the first time. Determining the safety of a drug, therapy or device is the main objective of phase I and only a small number of volunteers are used for these studies.
Phase II studies test an investigational drug with a larger number of volunteers to learn more about side effects, how the body uses a study drug, and how effective the treatment is or how it helps the condition.
Phase III and IV studies use larger numbers of volunteers and may compare the investigational drug or therapy with a commonly used drug or therapy or a placebo (an inactive substance). Additional safety and effectiveness information is also collected during these studies.
