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nQuery is a clinical trial design platform used for the design and monitoring of adaptive, group sequential, and fixed sample size trials. It is most commonly used by biostatisticians to calculate sample size and statistical power for adaptive clinical trial design. nQuery is proprietary software developed and distributed by Statsols. The ...
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]
Sample size determination or estimation is the act of choosing the number of observations or replicates to include in a statistical sample. The sample size is an important feature of any empirical study in which the goal is to make inferences about a population from a sample. In practice, the sample size used in a study is usually determined ...
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 ...
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 open-label trial, or open trial, is a type of clinical trial in which information is not withheld from trial participants. [1] In particular, both the researchers and participants know which treatment is being administered. [1] This contrasts with a double-blinded trial, where information is withheld both from the researchers and the ...