Participating in a clinical trial allows patients to receive potentially ground-breaking treatment or therapies that are currently in development, advancing the frontiers of scientific knowledge and treatment of disease. Clinical trials are important to develop new therapies and treatments. Most of the standard treatments accepted and used by doctors today are based on the results of previous clinical trials.
Clinical trials are strictly controlled research studies conducted on people. Each study is carefully designed to answer specific questions about a new treatment like a drug or a medical device to make sure it is safe and effective to use in people.
The details of the clinical trial, including all the tests and procedures used in the study, are outlined in a research plan, also called a protocol. The doctors, nurses, and scientists who run the clinical trial must follow the protocol and run the tests according to the strict rules set by the Food and Drug Administration (FDA) and other government agencies. The rules ensure that people who participate in the clinical trial are treated as safely as possible.
How am I protected if I join a clinical study?
A breadth of laws and regulations exist, as well as the ethical commitment of the research sponsors and institutions, to treat all patients with respect, beneficence and justice protect any patient who participates in clinical research. An Institutional Review Board (IRB) is in place at a St. Vincent Health to assure that these commitments are upheld.