A clinical research study, also called a clinical trial or research study, is a carefully designed scientific evaluation of a potential new drug (study drug). Clinical research studies are conducted by doctors and researchers. A clinical research study helps to answer important questions about a potential new drug, such as:
A potential new drug, also sometimes called a study drug, has been tested in a laboratory. Based on those results, it has been approved by health regulatory authorities for testing in people. A potential new drug also may be a drug that is approved for the treatment of one disease or condition but is still under investigation in other diseases or conditions. A potential new drug can only be used in clinical research studies.
All medications must be tested in clinical research studies before they can be approved for doctors to prescribe to patients. We need people to take part in clinical research studies so that new drugs can be developed.
There are always risks and benefits of participating in a clinical research study. There is always a chance that the study drug could cause side effects or will not work. However, there are strict rules in place to monitor the safety of people taking part in the study. Before joining any clinical research study, it is important to consider the risks and understand what they are.
The study team will explain all of the risks and benefits at the first study visit. Throughout the study, a team of doctors and nurses will closely monitor the health of the people taking part. They will be there to answer any questions.
If you would like to know whether you or a loved one might be eligible for the study, please fill out the form (you will be told immediately). If you or your loved one are eligible, we will match you/them to a clinical research study center in your area that is part of the study. We will also help you schedule your/their first study appointment at the study center. Please note that before being enrolled in the study, additional eligibility criteria will be checked by the study doctor or study team during the screening process.
The study-required study drug or placebo will be provided at no cost. Study-related care from a team of experienced doctors and nurses will also be provided throughout the study at no cost to study participants.
All personal information will remain confidential. Data will only be collected and used as necessary to support an individual’s match to, and participation in, a study. The names of people taking part in the study will not be included in any data reported. For more information, including how and why we process personal data, please read our Privacy Policy.
Clinical research studies must undergo rigorous reviews and follow strict rules. These rules help to ensure that the rights, safety, and well-being of participants are at the forefront of any study.
Taking part in a clinical research study comes with risks as well as benefits. Before joining a study, potential participants must make sure they understand the benefits, such as getting access to study-related medical care and maybe helping others in the future. They must also understand the risks, such as unknown side effects. Potential study participants and their care partners can take as much time as they need to decide whether to take part and get as much information as they can.
Before joining a study, the potential study participant and their care partner will be asked to sign an informed consent form, which will include a full explanation of the study, including its potential risks. If the potential study participant is not capable of giving informed consent, a legally authorized representative may provide informed consent on their behalf. In this situation, the potential study participant would provide informed assent.
It is up to you/your loved one to decide if you/they want to take part in the Radiant Study. Participation in the study is voluntary. Please also consider:
People taking part in the study will need to follow all the instructions from the study doctor and nurses.