It is not unusual for any of us to take medication on an intermittent basis, if not a daily basis. How do we know what we are taking? How do we know it is safe?
The FDA (Food and Drug Administration) is the federal agency responsible for regulating the sale of food, drugs, and cosmetics in the United States. It is this agency that regulates the research that determines if new drugs are allowed on the market for individuals to buy or for physicians to prescribe.
Pharmaceutical companies must conduct much research in the lab before the FDA will allow testing on humans. Then clinical trials or research studies are done with human subjects. After all the information is collected, the company presents the information to the FDA. This can be a long process, most often taking years.
What is a clinical trial?
A clinical trial or research study is an organized test of a new medication, device or treatment option. Individuals volunteer to participate in these studies. Sometimes the medications are drugs used in other countries, but the FDA requires they be tested here before making them available in the United States. Sometimes the medications are already on the market, but they need to be tested for a new purpose. Participation in these trials is always voluntary. In most clinical trials the treatment, office visits, and related tests are provided at no charge to the patient or their insurance company. In some cases there is financial compensation for participation to cover travel costs and time commitments.
What is an informed consent?
An informed consent is a detailed form describing the study, the procedures associated with the study, the potential risks and the potential benefits. This form should answer your questions or concerns about participating in the study. All study participants must sign an informed consent form and should be given a copy of the form. It is during the consent process that the patient should ask questions about the study and require the study staff to explain anything they do not understand.