Clinical study design is the formulation of clinical trials and other experiments, as well as observational studies, in medical research involving human beings and involving clinical aspects, including epidemiology . It is the design of experiments as applied to these fields. The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP) 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.
Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and medical ethics.
