====== Study design ====== 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. ---- [[Method]]ological [[quality]] refers to the level of [[rigor]] and [[validity]] in the [[design]], [[implementation]], and [[analysis]] of a [[research]] study. In other words, it refers to how well a study has been conducted and how confident we can be in its findings. Some factors that can affect methodological quality include the [[sampling]] method, [[data collection]] techniques, the use of appropriate [[measure]]s and statistical analyses, the control of [[confounding]] variables, and the reporting of [[results]]. A study with high methodological quality is more likely to produce reliable and accurate results and to be considered trustworthy by other researchers and the scientific community.