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The term "clinical research" refers to the entire process of studying and writing about a drug, a medical device or a form of treatment, which includes conducting interventional studies ( clinical trials) or observational studies on human participants. [ 1][ 3] Clinical research can cover any medical method or product from its inception in the ...
The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. [ 1] For drug development, the clinical phases start with testing for drug safety in a few human subjects, then expand to many study ...
Clinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study ...
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. [ 1] The goal of a clinical study is to assess the safety, efficacy, and / or the mechanism of action of an investigational medicinal product (IMP ...
Preclinical development. In drug development, preclinical development (also termed preclinical studies or nonclinical studies) is a stage of research that begins before clinical trials (testing in humans) and during which important feasibility, iterative testing and drug safety data are collected, typically in laboratory animals.
Pivotal trial. A pivotal trial is typically a Phase III clinical trial in the multi-year process of clinical research intended to demonstrate and confirm the safety and efficacy of a treatment – such as a drug candidate, medical device or clinical diagnostic procedure – and to estimate the incidence of common adverse effects. [1]
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