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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. 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.
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Search interest data over the past 12 months indicates that this topic periodically attracts global attention. Sudden spikes often correlate with major news events, public statements, or geopolitical developments.