A clinical study involves research using human volunteers (also called participants) that is intended to add to medical knowledge. There are two main types of clinical studies: clinical trials (also called interventional studies) and observational studies. ClinicalTrials.gov includes both interventional and observational studies.
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.
EWMRI specializes in “late phase” (Phases 2 through 4) research studies, which means that participants are required to have the disease or condition being studied. Participants are typically asked come to our office for brief outpatient visits once or twice a month. The goal of these visits is to measure effectiveness of the drug or device being studied, and to monitor for safety.
All new medications are required to be tested for safety and effectiveness prior to the U.S. Food and Drug Administration (FDA) will allow them to become available to the public. You can find more information on the clinical trial process at the U.S. NIH site http://clinicaltrials.gov
