Taking medication is a daily activity for most people. Do you ever wonder what you are really ingesting? Is the medication you are taking safe or harmful? The purpose of clinical trials is to determine whether the medication is safe or harmful.
The FDA (Food and Drug Administration) is the federal agency responsible for regulating the sale of food, drugs, and cosmetics in the United States. This agency regulates the research of new drugs before they are released to market or prescribers alike.
Pharmaceutical companies conduct research in the lab prior to the FDA allowing research to be transitioned from animals to humans. After the data is collected and analyzed the company presents the information to the FDA.
What is a clinical trial?
A clinical trial known as a research study is the process of testing new medications, devices or treatment options. During a trial, data is collected and analyzed for safety and efficacy purposes. Individuals choose to volunteer and participate in these studies. Some drugs may already be approved in other countries, however the FDA requires further testing to be approved for use in the United States. A clinical trial may also take place if a product is being tested for a different purpose. Participation in these trials is always voluntary and can be withdrawn at any time the patient wishes. In most clinical trials the treatment, office visits, and related tests are provided at no charge to the patient or their insurance company. Often times, 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 which describes the study, study procedures , and gives the potential risks and benefits. The informed consent should answer most questions the patient may have regarding the study. However, our research staff, PI and Sub-I is always available to answer any further questions. Once the decision has been made to participate, the patient must sign the informed consent and will be given a copy to take home.