Study design in the context of "Natural experiment"

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⭐ Core Definition: Study design

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 (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 medical ethics.

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👉 Study design in the context of Natural experiment

A natural experiment is a study in which individuals (or clusters of individuals) are exposed to the experimental and control conditions that are determined by nature or by other factors outside the control of the investigators. The process governing the exposures arguably resembles random assignment. Thus, natural experiments are observational studies and are not controlled in the traditional sense of a randomized experiment (an intervention study). Natural experiments are most useful when there has been a clearly defined exposure involving a well defined subpopulation (and the absence of exposure in a similar subpopulation) such that changes in outcomes may be plausibly attributed to the exposure. In this sense, the difference between a natural experiment and a non-experimental observational study is that the former includes a comparison of conditions that pave the way for causal inference, but the latter does not.

Natural experiments are employed as study designs when controlled experimentation is extremely difficult to implement or unethical, such as in several research areas addressed by epidemiology (like evaluating the health impact of varying degrees of exposure to ionizing radiation in people living near Hiroshima at the time of the atomic blast) and economics (like estimating the economic return on amount of schooling in US adults).

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Study design in the context of Statistical theory

The theory of statistics provides a basis for the whole range of techniques, in both study design and data analysis, that are used within applications of statistics. The theory covers approaches to statistical-decision problems and to statistical inference, and the actions and deductions that satisfy the basic principles stated for these different approaches. Within a given approach, statistical theory gives ways of comparing statistical procedures; it can find the best possible procedure within a given context for given statistical problems, or can provide guidance on the choice between alternative procedures.

Apart from philosophical considerations about how to make statistical inferences and decisions, much of statistical theory consists of mathematical statistics, and is closely linked to probability theory, to utility theory, and to optimization.

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LINKED FROM (PARENTS)
← Natural experiment ← Statistical theory
LINKS TO (CHILDREN)
Clinical trial → Experiment → Observational study → Medical research → Human being → Clinic → Epidemiology → Design of experiments → Food and Drug Administration → Patient confidentiality → Medical ethics →