A Study of the Drug Efruxifermin for Treating Liver Diseases and Scarring of the Liver

What is Be Involved?
This website lists clinical studies that are looking for volunteers. Each study summary explains why the study is being done. The summary also gives details on who can volunteer. To learn more about a study, contact information is provided.

What is a clinical study?
A clinical study tests how well a study drug or treatment works to treat a disease or condition in people. It also helps researchers learn if the study drug or treatment is safe. A clinical study may also be called a clinical trial or clinical research.

Why would I consider being in a clinical study?
There are different reasons to take part in a study. 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 be helping to gain a better understanding of how the human mind and body work.

What are the different types of clinical studies?
There are 5 common types of clinical studies.

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 stop disease from happening or stop 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.

What are the phases of clinical studies?
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 if it would 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.

Who can take part in research studies?
There are research studies being done for many conditions and illnesses. Every study has requirements (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. Other studies include healthy volunteers who do not have the illness for which the study drug is being tested.

What is a healthy volunteer?
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!

Is there any danger in taking part in a clinical study?
Clinical studies have possible risks. Both risks and benefits are different with each study. Not all study volunteers will react to the study risks or benefits in the same way. Clinical trials take place under rules to protect the well-being and rights of study volunteers. Researchers can only do a study after a group called Independent Review Board (IRB) approves the study. The IRB makes sure the study is done in a way that keeps risks as low as possible for volunteers. The IRB also makes sure the possible benefits of doing the study outweigh the risks. It is important for you to ask the study team questions to make sure you understand the risks and benefits when you are thinking about taking part in a study.

How do I learn more about clinical studies you are doing at your facilities?
If you are looking for a study for a disease or illness, click on the “Search Studies” button at the top of the (TBN) site. When on the “Search Studies” page, type in the name of the disease or condition you are looking for in the box and click “Submit.” You will see studies for that disease or illness.

Do I have to take part in a study if I sign up to learn more?
If you sign up to learn more about a study listed on our site, 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.

Do I have to stay in a study once I have started taking part?
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.

Do I get paid to be in a study?
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. Payment is for your time to be in the study and travel to and from the study location.

What if I change my mind about finding out more information on a study listed on your site?
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 our site know that you are no longer interested so they know not contact you again on this study.

Will I start getting a lot of email if I request more information on a study?
You will not start getting a lot of email if you request more information about a study. After filling out the interest form, you will only be contacted about that specific study. If you decide you are not interested after learning more about the study, you will not be contacted again.

Is the information I supply secure?
We take your privacy very seriously. This 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.

What can I do if I have more questions about clinical research?
For general questions about being in a research study or to find out more about how to use this site, please contact us at 336-713-3194, send email to beinvolvedregistrar@wakehealth.edu, or fill out the online form provided under the Contact Us tab.

Where can I learn more about clinical studies at other locations?
The National Institutes of Health website has information about clinical studies that are going on across the world. Go to www.clinicaltrials.gov and look for studies that are “recruiting.” Recruiting means the study is seeking volunteers to be in the study.

Adverse Reactions or Side Effects: Adverse reactions or side effects are undesired physical reactions to a study drug or device.

Blinded Study: In a blinded study, study volunteers are randomly assigned (like a flip of a coin) to receive different treatments. The  volunteers and/or study team members do not know which volunteers are getting which treatment.

Clinical Study: A study with human volunteers that tests how well a study drug, device or other treatment works for treating a disease or condition. It also tests how safe the study drug, device or other treatment is for people. A clinical study may also be called a clinical trial or clinical research.

Control Group: Study volunteers that will not receive the study drug are called a control group. The control group can receive a placebo, which is a harmless substance that looks like the study drug and has no impact to the body.

Eligibility Criteria: Each study has study criteria or rules about who can be in a study. Study criteria are carefully chosen to make sure the trial can prove whether a study drug works or not in certain volunteers. The rules are applied equally to all those who could be in the study. These rules or criteria include things like your age, your gender, type and stage of a disease, prior treatment history, and other medical conditions.

Healthy Volunteer: A person in a research study who does not have significant health problems.

Informed Consent: This is the process where a study team member will explain the study and you can ask questions. It is important that you understand the facts of the study so you can make an informed choice about being in the study. In this process you will learn why the study is being done, what you will need to do for your part in the study, how long the study lasts, and known risks and potential benefits of being in the study.

After hearing the study details and getting answers to all your questions, you can decide if you want to be in the study. If your decision is to take part, you sign a document called an informed consent that shows you understand the known study facts and want to be in the study. Signing an informed consent document is not a contract and you can leave a study at any time.

Interventional Study: A study that tests how safe and how well a new drug, device or other medical intervention works in people.

Observational Study: Observational studies do not include any sort of treatment. The researchers observe and measure certain outcomes. This type of study tries to find out why certain physical or behavioral things happen in relation to a disease or treatment. These studies usually collect large amounts of information over time.

Placebo: A substance that does not have study drug in it and will have no impact on the body. It looks the same and is given in the same way as the test drug being studied.

Principal investigator (PI): The doctor or researcher in charge of the clinical study.

Protocol:  This is the written description of a clinical study. It includes why the study is being done, how the study will be done, and when each step will need to take place during the study. It also includes information from earlier research done in labs and sometimes earlier studies in people.

Randomized Study: In these studies, volunteers are divided by chance into separate groups. Different treatments are given to the volunteers in the different groups. Using chance to divide people into groups means that the groups will be similar and that the effects of the treatments they receive can be compared more fairly.

Side Effects or Adverse Reactions: Side effects or adverse reactions are undesired physical reactions of a study drug or device.

Study Volunteer: A study volunteer can also be called a study participant or a patient. Study volunteers are the medical heroes who shape the future of healthcare!