[1][3] Clinical research can cover any medical method or product from its inception in the lab to its introduction to the consumer market and beyond.
People with current or past experience of illness can provide a different perspective than professionals and compliment their knowledge.
Public contributors can also ensure that the research is presented in plain language that is clear to the wider society and the specific groups it is most relevant for.
[1][3] If the drug successfully passes through Phases I, II, and III, it will be approved by the national regulatory authority for use in the general population.
[8] In the United States, when a test article is unapproved or not yet cleared by the Food and Drug Administration (FDA), or when an approved or cleared test article is used in a way that may significantly increase the risks (or decreases the acceptability of the risks), the data obtained from the preclinical studies or other supporting evidence, or case studies of off label use are submitted to the FDA in support of an Investigational New Drug application.
These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials.