Clinical Trials Need Healthy People, Too

The medicines used every day to treat you and your family were developed thanks to people who were willing to take part in clinical research. You probably know that patients with a specific illness or condition sometimes participate in clinical research. But did you know that you don’t have to be sick to take part in a research study?

Many studies need healthy volunteers to provide information that can be compared with that from people who have a particular disease. In fact, there are several reasons to participate in clinical research as a healthy volunteer:

•    You may have the opportunity to further medical knowledge and help researchers develop new treatments.
•    You may receive compensation for taking part in a research study.
•    Volunteering for a research study offers the satisfaction of helping those who suffer from diseases that can be chronic, serious, or even life-threatening.
•    Healthy volunteers who participate in early clinical research studies may help determine the safety, dosage and side effects of a new drug or treatment.

Yale has a number of studies that need healthy volunteers to help doctors develop treatments for a variety of diseases. Here are a few examples:

Diabetes


In this study, doctors are examining the effect of glucose levels on the brain. Healthy adults who are not overweight or on medication view photos of food and other items while undergoing an MRI scan to see how the images affect brain activity. Then they are given glucose (a type of sugar) intravenously to find out how changes in their insulin levels affect the brain when looking at the same images.

Healthy volunteers are needed to help doctors understand what happens to a healthy person versus someone with a medical problem. “In this case, we know people with diabetes have high glucose levels and we’re trying to understand if that affects how they look at food, but we need to also see the normal physiology,” explained Dr. Renata Belfort De Aguiar.

PET Center


Another study involves a new drug that is being developed to treat lung fibrosis, in which excess connective tissue in the lung causes shortness of breath and other symptoms. Healthy males with no history of psychiatric illness between the ages of 18 and 45 are eligible to participate. The study involves a PET scan, which is a diagnostic exam that provides visual images of organ function. Prior to the PET scan, a radioactive compound that was developed at Yale is injected into the body. This radiotracer allows imaging of the lungs to detect a receptor for the new drug.  A low dose CT scan is also given to help align the images. The amount of radiation in the radiotracer and the CT scan is well below the limits allowed by the FDA. The study team monitors the radiation in the blood through an intravenous line inserted in the wrist.

This study is an early phase of testing to make sure the tracer is effective at detecting whether the drug can be taken into the body. This is the first time the tracer will be tested in humans in what is called a Phase I study. In this phase, clinical studies with healthy volunteers help doctors determine if a medicine (or a radiotracer in this case) is safe and effective. The drug itself will be tested in a second study, which also needs healthy volunteers, and which involves PET and MRI scans. The Yale PET Center is conducting similar studies to test radiotracers that may be used in treating Alzheimer’s disease and chronic pain disorder.

Both of these studies offer compensation in varying amounts to volunteers, depending on the procedures that are performed. To find out about diabetes studies that need healthy volunteers, call Dr. Belfort De Aguiar at 203-785-6222 or e-mail glucose.studies@yale.edu. To find out if you’re eligible for a PET study that needs healthy volunteers, contact Elizabeth Correa at 203-737-7496 or elizabeth.correa@yale.edu.