Clinical trials are medical research that involves people. Individuals volunteer to participate in carefully conducted investigations that ultimately uncover better ways to treat, prevent, diagnose and understand human diseases.
Studies that test new treatments and therapies as well as long–term natural history studies, which provide valuable information about how disease and health progress.
Ideas for clinical research—also known as clinical trials or clinical studies—often originate in the laboratory or patient-care settings. Often doctors are prescribing the medication "off label" for uses that have not been officially investigated. After researchers test new therapies or procedures in the laboratory and in animal studies, the most promising experimental treatments are moved into clinical trials, which are conducted in phases. During a trial, more information is gained about an experimental treatment, its risks, and its effectiveness.
Clinical research is conducted according to a plan known as a protocol. The protocol is carefully designed to safeguard the participants’ health and answer specific research questions. A protocol describes the following:
Who is eligible to participate in the trial
Details about tests, procedures, medications, and dosages
The length of the study and what information will be gathered
A clinical study is led by a principal investigator, who is often a doctor. Members of the research team regularly monitor the participants’ health to determine the study’s safety and effectiveness. Patients are closely monitored by the clinical research staff and are consistently given feedback about their health and condition throughout study. Patient safety is the main priority of Greenville Pharmaceutical Research.