The Atlanta Center for Medical Research is seeking volunteers to participate in a child/teen clinical study on Bipolar I.
Why It's Important
Children's Bodies Are Different
Only about 30% of all medicines that are given to children during medical visits have been tested specifically for use on children. This means research is needed to see how certain medicines and procedures affect their health as they continue to grow and develop. Clinical trials will lead the way to creating more effective, efficient, and safe treatments for children and teens.
Benefits for Children
Your child will have access to new medicines that aren’t available to the public yet in which researchers believe will work better or are safer than the standard.
Closer Monitoring/Additional Testing
Clinical trials also offer closer monitoring or additional testing for your child compared to regular care.
Helping Future Generations
By testing the safety and effectiveness of new medicines, your child is helping future generations find what works and what doesn’t. Participating in a clinical trial will help researchers and the public learn more about how to treat your child’s condition while becoming part of a community that understands what you’re going through.
Making the Decision
Our Highest Priority Is Your Child
We understand that it can be a scary decision to have your child participate in a clinical trial. Rest assured, the safety and well-being of your child is the highest priority not only for you, but for the research team as well. Before deciding, information about the trial along with all the risks and benefits of participating will be disclosed in an informed consent document. Don’t hesitate to ask questions. In fact, questions are encouraged so that you feel more comfortable while being more informed about each step of the research process.
Before your child is even able to sign up for a clinical trial, the said medicine has already passed two major stages of testing and checks for safety. In the first stage, the medicine has been testing in a lab. Then, the testing takes place in adults and older children when possible.
Next, when your child is able to get involved, he or she will participate in one or more of these essential phases:
- The first phase is where small doses of the medicine are given to test tolerance/side effects.
- The second phase is to take note of how effective, or ineffective, the medicine was to the disease.
- The third phase is where researchers have to make the decision of whether or not it would make sense for other health care professionals to adopt the medication as a dependable form of treatment.
- The fourth phase, often called Post Marketing Surveillance Trials, is conducted after a drug or device has been approved for consumer sale, according to CenterWatch.
It’s important to note that you have the freedom to withdraw your child from participation of a clinical trial at any point.
Safety and Protections for Children
The government enlists special protections for children in regards to protecting them in clinical research. There are also independent committees that are solely dedicated in making sure your child is safe and being treated ethically throughout the entire research process. Called Institutional Review Boards (IRBs), they review studies both before they start and throughout the study. Some studies have a Data and Safety Monitoring Board that regularly monitors safety or a Medical Monitor — a doctor or nurse not associated with the study who reviews side effects that occur.
Some studies may involve large teams while other ones only have one or two individuals managing the study.
Principal Investigator (PI)
Principal Investigator is a medical doctor, or other health care professional, that is responsible for the entire study. The PI oversees the safety of all the participants and can also be your child’s regular doctor.
Research Coordinators are responsible for a variety of tasks. They handle patient recruitment as well as facilitating the trial along with the study doctor. A part of their role is to also collect data and follow up with participants.
The Research Assistants make sure everything runs seamlessly.
They have an understanding of all parts of the study and make sure the staff has the right equipment, medication, or devices needed for the study. Institutional review boards, study sponsors, oversight committees, and federal regulators are also important groups of people that interact with study teams during the trial.
Questions to Ask
Questions are encouraged throughout the trial to avoid confusion or discomfort. It’s recommended to prepare questions for your doctor or research team and to ask any questions that come up along the way.
Learn some good questions to ask if you're considering having your child participate in a clinical trial.
All information pulled from: www.childrenandclinicalstudies.org