Image from: Harvey, BJ, Lang ES, JR Frank, eds. The research guide: a primer of residents, other health care trainees, and practitioners. Ottawa: Royal College of Physicans and Surgeons of Canada; 2011.
In a clinical trial, participants receive specific interventions according to the research plan or protocol created by the investigators. These interventions may be medical products, such as drugs or devices; procedures; or changes to participants' behavior, such as diet. Clinical trials may compare a new medical approach to a standard one that is already available, to a placebo that contains no active ingredients, or to no intervention. Some clinical trials compare interventions that are already available to each other. When a new product or approach is being studied, it is not usually known whether it will be helpful, harmful, or no different than available alternatives (including no intervention). The investigators try to determine the safety and efficacy of the intervention by measuring certain outcomes in the participants. For example, investigators may give a drug or treatment to participants who have high blood pressure to see whether their blood pressure decreases. Clinical trials used in drug development are sometimes described by phase. These phases are defined by the Food and Drug Administration (FDA).
From the U.S. National Library of Medicine.
The following tools and checklists can help you appraise the quality of clinical trial methods and reporting in order to determine the trustworthiness of the study findings.