Being a Study Volunteer

The Atrium Health Be Involved website lists clinical studies that are looking for people to take part in research. Each study outlines why the study is taking place, what physical traits are needed to be in the study, and information to contact someone to learn more about the study.

A clinical study is a scientific process to test whether a study drug or therapy is safe and works on the disease or condition in people. A clinical study may also be called a clinical trial or clinical research.

Being in a clinical study can help researchers improve medical care for yourself and others. You could gain access to potential treatments before they are widely available. You could also be helping to gain a better understanding of how the human mind and body work.

There are 5 common types of clinical trials:

1. Treatment or interventional studies test new drugs, therapies, or devices in and on the body.
2. Diagnostic studies find new tests or procedures to tell if you have a disease or condition or how much a disease may have advanced in your body.
3. Prevention studies look for ways to prevent disease from occurring or prevent disease from returning.
4. Screening studies test the best ways to find out if you have a certain disease or condition.
5. Quality of life or supportive care studies look at different ways to improve comfort and living with a long-term illness.

Each step in developing a new study drug or therapy is called a phase. Each phase takes place to better understand if the study drug can change a disease and how the study drug might affect people. Each phase is reviewed and approved by the U.S. Food and Drug Administration (FDA) before the study can move into the next phase. The FDA review makes sure the way the study is being done will prove if the study drug or therapy could help people and not cause harmful reactions.

• Phase I: Tests a study drug or therapy for the first time in a small group of people to find out if it is safe and learn if there are side effects or reactions.
• Phase II: Involves more people to see how well the study therapy works in a disease and further check how safe it is.
• Phase III: Includes larger groups of people to see how well the study drug works against a disease and further check how safe it is.
• Phase IV: These are also known as post-marketing studies as the study therapy has already been approved by the FDA. These studies look at how new drugs and treatments impact large groups of people over a long period of time. These studies can look at certain groups of people, such as specific age groups, genders, races; people taking other medications, or people with other diseases.

There are research studies being done in many conditions and illnesses. Every clinical study has eligibility criteria (physical traits) that people need to have to be in the study. Some studies test a study drug only in people with a disease or condition. Some studies include healthy volunteers, those who do not have the illness for which the study drug is being tested.

A healthy volunteer is a person in a research study who does not have the illness for which the study drug or therapy is being tested. Often healthy volunteers have no significant illness of any type. Being a healthy volunteer is very important. Healthy volunteers can provide health information that can be compared to people with certain health conditions or diseases. This comparison helps to understand why people get some diseases and others do not. This information can lead to new ways to find or treat health conditions. When you are a healthy volunteer, you are helping many people and the future of healthcare!

Clinical studies have potential risks. Both risks and benefits vary with each study and not all study participants will experience risks or benefits in the same way. Clinical trials take place under regulatory and ethical rules to protect the welfare and rights of study participants. Researchers can only do a study after an independent group called an Independent Review Board (IRB) approves the study. The IRB makes sure the study is set up in a way that risks are as low as possible for participants and potential benefits outweigh risks. It is important for you to ask questions of the study team to make sure you understand the risks and benefits when you are thinking about taking part in a study.

If you are looking for a study for a disease or illness, click on the “Search Studies” tab at the top of the Be Involved site. When on the “Search Studies” page, enter that disease or condition in the box and click “Submit” to find studies related to that topic.

If you sign up to learn more about a study listed on Be Involved, you do not have to take part in that study and you may not have all the traits needed to be in that study. Signing up just allows you to get the study information.

You can leave a clinical study at any time for any reason and no matter how long you have been in the study. If you decide to leave a study, you should let a member of the study team know that you have decided to leave the study. This is so the study team knows to not keep contacting you.

Some clinical studies pay or reimburse those in the study. These payments, if any, are different for each study. The amount is based on the phase of the study, the types of things you will do in the study, and the number of times you will need to do something for the study. For most clinical studies, the study drug or therapy and visits with the study team are at no cost to you. For some studies, such as Phase IV studies, payment is for your time to be in the study and travel to and from the study location.

There is no contract or commitment to receive information on a study. You can change your mind at any time without giving a reason. You would want to let the study team contact listed with the study on Be Involved that you are no longer interested. This ensures they will not contact you again on this study.

Once you ask for more information on a study, you will be contacted via email only about that study and this will only happen when you asked for more information on a study. Also, after you get the first contact with study information, you can say you have no interest, and you will not be contacted again on that study.

We take your privacy very seriously. Be Involved is a secure site and no information will be sold, rented, or leased to other parties. Please visit this link for more information on our privacy policy.

For general questions or to find out more about Be Involved, you can contact us at 336-713-3194, send email to beinvolvedregistrar@wakehealth.edu, or fill out the online form provided under the Be Involved Contact Us tab.

The website for the National Institutes of Health has information about clinical studies that are happening throughout the world. Go to www.clinicaltrials.gov and look for studies that are “actively enrolling,” which means they are seeking people who may be interested in being in a study.