What is clinical research?
Clinical Research involves studies using volunteers to test new methods of screening, prevention, diagnosis, or treatment of a disease. A clinical trial is used to determine if an investigational drug or therapy is both safe and effective. Clinical trials also determine new ways of using existing drugs or therapies.
Clinical trials are required by the Food and Drug Administration (FDA) before any medication can be used by the general public. Institutional Review Boards(IRB) and Ethics Committees provide oversight for clinical studies and ensure strict FDA Guidelines are followed. Clinical trials are carefully designed and monitored to ensure the safety of patient volunteers. Most trials involve some risk of harm or injury to the patient, although it may not be greater than the risks related to routine medical care or disease progression. IRB decides that the risks of participation have been minimized and are reasonable in relation to anticipated benefits prior to approving a clinical study. These risks and study protocol requirements will be described in the informed consent document.
Every clinical study is led by a principal investigator, who is often a medical doctor. Patients are closely monitored throughout the study via physical exams, laboratory tests and other medical procedures. Patients will also receive study-medication, at no charge throughout the course of the study. Typically, participants continue to see their usual health care providers while enrolled in a clinical study. By having his or her usual health care provider work with the research team, a participant can make sure that the study protocol will not conflict with other medications or treatments that he or she receives.
Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future. The results of these studies can make a difference in the care of future patients by providing information about the benefits and risks of therapeutic, preventative, or diagnostic products or interventions.
For more information, you may visit this website for National Institutes of Health: