What is a clinical research study?
Clinical research studies are designed to test the safety and effectiveness of investigational drugs before they are submitted to the U.S. Food and Drug Administration (FDA) for approval and for general use by the public. All clinical studies are conducted under the direction of healthcare professionals. Researchers must comply with guidelines and safeguards to protect study participants. In addition, an institutional review board (IRB) must approve every study. An IRB is an independent committee that is typically made up of physicians, statisticians, community advocates, and others, and that helps ensure that a study is ethical, and that the rights of the patient are protected. With these controls in place, the study begins. Potential participants are educated about possible risks and benefits to ensure that their decision to participate is well-informed. You may decide to stop participating in a clinical study at any time.
Researchers evaluate the effectiveness of new medications, treatments and devices through clinical research studies. Investigational drug studies may involve comparing the study drug effectiveness and safety with other marketed medications or placebo (inactive drug), evaluating a drug for a new use, or evaluating different dosages or combinations of medications.
Clinical research studies are designed to test the safety and effectiveness of investigational drugs. All clinical research studies are conducted under the direction of healthcare professionals. Researchers must comply with guidelines and safeguards to protect study participants. In addition, an institutional review board (IRB) must approve every study. An IRB is an independent committee that is typically made up of physicians, statisticians, community advocates, and others to help ensure that a study is ethical and that the rights of the patient are protected.
A “Clinical Research Study” or “Clinical Trial” is the scientific term for a test of drugs or medical devices in people. These tests are done to see if the product is safe and effective for people to use. By taking part in a clinical study, you can try a new treatment that may or may not be better than those that already exist. You can also help others better understand how the treatment works in people and contribute to the advancement of science. Because the treatments being studied are new, doctors don’t always know what the side effects will be. Many side effects are temporary and go away when treatment is stopped, others may be permanent. The risks will always be fully explained to you by the researchers before you participate in a study. The US Food and Drug Administration (FDA) and the hospitals require that you be given a document called an “informed consent” that tells you all about the clinical study: the purpose of the research, how long the study will take, the risks, any p
