Clinical Trial Design Task
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A Clinical Trial Design Task is a Experiment Design Task that produces a clinical trial.
- AKA: Clinical Study Design.
- Example(s):
- Counter-Example(s):
- See: Research Design, Scientific Control, Clinical Trial Management System, Decentralized Clinical Trial (DCT).
References
2021
- (Wikipedia, 2021) ⇒ https://en.wikipedia.org/wiki/Clinical_study_design Retrieved:2021-11-21.
- 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) 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.
Some of the considerations here are shared under the more general topic of design of experiments but there can be others, in particular related to patient confidentiality and ethics.
- 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) 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.
- ↑ Miquel Porta (2014) "A dictionary of epidemiology", 6th edn, New York: Oxford University Press. .