What is a Clinical Trial?

A clinical trial is a study of an investigational medication or investigational treatment, in order to see how well it works and to assess its safety. Before a clinical trial can occur, the treatment must have been studied in the laboratory and on animals.

 Why do we need clinical trials?

The Food and Drug Administration requires that clinical trials be conducted with investigational medications before it will approve their use with the general public. This is to ensure that the investigational medication is effective and safe.

 Who can participate in a Clinical Study?

All clinical studies have guidelines called inclusion/exclusion criteria that determine who can participate in the program. These guidelines are based on such factors as age, type of disease, medical history, and current medical conditions. These criteria are used to identify appropriate participants and keep them safe as well as to ensure that researchers will be able to answer the questions being asked.

 What are the benefits if I participate?

There are both benefits and risks associated with clinical studies. While participating in a clinical study you can:
– Take an active role in your own health care.
– Gain access to new treatments that are not available to the general public.
– Obtain medical care.
– Help others by contributing to medical research.

 What protections are there for participants in a clinical study?

The government has strict guidelines and safe guards to protect people who choose to participate in clinical studies. Every clinical study in the United States must be approved and monitored by an Institutional Review Board (IRB) to make sure risks are as low as possible and are worth any potential benefits.

You will receive an informed consent document and given an opportunity to read it and ask any questions. A copy of it will then be given to you.

 What is a placebo?

A placebo is an inactive pill, liquid, or powder that has no treatment value. In clinical studies, experimental treatments are often compared with placebos to assess the treatment’s effectiveness. The informed consent will describe the chance, if any, if you will receive a placebo during the clinical study.

 What are the risks of participating in a clinical research study?

– There may be side effects or adverse reactions to medications or treatments
– The treatment may not be effective for you
– It may require extra trips to the study site

 Will it cost me to participate?

Usually no cost will be incurred by participating in a clinical study. This will be clearly outlined in the informed consent.

 Can I discontinue from a study after I have already started it?

You can leave a clinical study at any time. If you plan to stop participating, let the research team know why you are leaving the study. You will need to return to the study site to be withdrawn from the study.

 Who sponsors the clinical trials?

Clinical studies are sponsored by Government agencies, pharmaceutical companies, individual physician investigators, and organizations that develop medical devices. Studies can take place in hospitals, doctor’s offices, or universities, as well as independent research facilities.

 How can I volunteer?

To volunteer for one of our studies or to get more information.