[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)[2] 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).
[4] 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.
Analytical When choosing a study design, many factors must be taken into account.
[citation needed] The ecological fallacy may occur when conclusions about individuals are drawn from analyses conducted on grouped data.
The nature of this type of analysis tends to overestimate the degree of association between variables.