What are clinical studies?July 15, 2013 2013-07-15 17:38
What are clinical studies?
Clinical study, and Clinical trial both signify the same — a scientific endeavor to find out how a novel drug or treatment works in humans. Through clinical studies, medical practitioners find a novel and a better way to thwart, perceive, identify, manage, and treat ailments.
In a clinical study, human volunteers are subjected to new interventions according to the clinical study plan or protocol laid out by the study investigators. These interventions may be medical related, such as novel drugs or medical devices; medical procedures; or changes to volunteers’ conduct, for e.g., food intake. Clinical trials may evaluate a new medical methodology by comparing it to a standard one that already exists in the market or to a placebo or to no medication. Some clinical studies judge against methodologies that already exist to each other.
When a novel product or a method is being studied, it is not typically known whether it will be useful, detrimental, or effective than existing alternatives. The clinicians or investigators try to conclude the safety and efficacy of the intervention by gauging certain outcomes in the human volunteers.
Each clinical study of a drug, medical device, biological product are regulated by a government body called regulatory authority and the clinical study must be reviewed, accepted, and monitored by an institutional review board (IRB) or institutional ethics committee (IEC). An IRB or IEC is made up of medical practioners, researchers, social scientists, and members of the community.