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A human challenge study, also called a challenge trial or controlled human infection model (CHIM), is a type of clinical trial for a vaccine or other pharmaceutical involving the intentional exposure of the test subject to the condition tested. [1][2][3] Human challenge studies may be ethically controversial because they involve exposing test ...
A clinical trial participant receives an injection. 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 ...
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 ...
An academic clinical trial is a clinical trial not funded by pharmaceutical or biotechnology company for commercial ends but by public-good agencies (usually universities or medical trusts) to advance medicine. [1] These trials are a valuable component of the health care system; they benefit patients and help determine the safety and efficacy ...
Analysis of clinical trials. Clinical trials are medical research studies conducted on human subjects. [1] The human subjects are assigned to one or more interventions, and the investigators evaluate the effects of those interventions. [1][2] The progress and results of clinical trials are analyzed statistically. [3][4]
A randomized controlled trial (or randomized control trial; [2] RCT) is a form of scientific experiment used to control factors not under direct experimental control. Examples of RCTs are clinical trials that compare the effects of drugs, surgical techniques, medical devices, diagnostic procedures, diets or other medical treatments. [3] [4]
Clinical research is a branch of medical research that involves people and aims to determine the effectiveness (efficacy) and safety of medications, devices, diagnostic products, and treatment regimens intended for improving human health. [1][2] These research procedures are designed for the prevention, treatment, diagnosis or understanding of ...
Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. [1] Clinical data management ensures collection, integration and availability of data at appropriate quality and cost. It also supports the conduct, management and ...
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