Clinical Research & Clinical Trials

Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research involving human beings. The goal of a clinical study is to assess the safety, efficacy, and the mechanism of action of an investigational medicinal product or procedure, or new drug or device that is in development, but potentially not yet approved by a health authority. It can also be to investigate a drug, device or procedure that has already been approved but is still in need of further investigation, typically with respect to long-term effects or cost-effectiveness. A randomized controlled trial is a type of scientific experiment which aims to reduce bias when testing a new treatment. An adaptive clinical trial is a clinical trial that evaluates a medical device or treatment by observing participant outcomes on a prescribed schedule, and modifying parameters of the trial protocol in accord with those observations.