What is a clinical study?
A clinical study is a research study in human volunteers designed to answer specific health questions. Clinical studies (also called "medical
research" and "research studies") are used to determine whether new drugs or treatments are both safe and effective. Carefully conducted
clinical studies are the safest and fastest way to find treatment that work in people, and new ways to improve health.
Many clinical studies are done to determine if a new drug or therapy is safe and effective for people to use. Some clinical studies are done to compare existing treatments to each other in order to determine which is better. Other clinical studies are done to learn how a certain treatment will be best used in a specific population, such as patients with diabetes, in whom the treatment was not previously tested.
We encourage you to discuss any and all concerns with our health care team. Please ask questions about the clinical studies you are interested in. You should know as much as possible about the clinical study and feel comfortable talking with our staff members.
Clinical studies are sponsored by a variety of organizations including doctors, medical institutions, foundations, pharmaceutical companies, or federal agencies such as the National Institute of Health or NIH. The sponsor of the clinical research hires physicians to conduct the clinical study. Of note, the FDA does not develop new therapies or conduct clinical studies; however, the FDA staff members meet with researchers and perform inspections of clinical study sites to protect the rights of participants and verify the quality and integrity of the data.
There are a variety of reasons why people choose to participate in clinical studies. You can try a potential new treatment that may be better than the current, standard treatment. This means you can gain access to promising therapies that are not widely available. You can also play an active part in your own health care an stake advantage of frequent monitoring of your health status through the clinical study. You can obtain expert medical care at a leading health care facility during the clinical study since the physicians conducting the studies are often specialists in the disease area being studied. You will have personalized, friendly, and confidential care along with free medicine and lab work associated with the clinical study. Participating in a clinical study also helps others by contributing to a medical research.
