Clinical study design is the formulation of trials and experiments, as well as observational studies in medical, clinical and other types of research (e.g., epidemiological) involving human beings. The goal of a clinical study is to assess the safety, efficacy, and / or 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 (e.g. Food and Drug Administration). 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.
This topic covers: Types of Clinical Study Designs, Descriptive studies: Case reports, Case series, Population study, Explanatory studies: Observation studies, Aggregate observation studies, Individual observation studies, Case-Control Study, Importance of Control Groups, Types of Control groups, Cohort Study, Types of Cohort studies, Cross-sectional Study/CrossOver study, Interventional / Experimental studies, Randomized controlled trials, Randomisation, Blinding in randomised controlled trials, Direct end point in Clinical study, Surrogate end point in Clinical study, Parallel Design / Parallel Group Study and Bias.