What is clinical trials research?
In clinical trial research, doctors and scientists design a study, called a protocol, to answer questions about health or illness. Through clinical trials, new medicines, devices and procedures are developed to help us learn how to prevent and treat illness. Every study must follow strict guidelines that have been established by law to protect anyone who participates in a research study. Before a study begins, it must first be reviewed and approved by an Institutional Review Board (IRB). This is a group of healthcare professionals and community members who review the risks and benefits and make sure that the participants are fully informed before agreeing to participate in a study.
Who participates in clinical trials?
Every study has specific guidelines explaining who can be in the study. Your child may have a condition or symptom or may be undergoing a procedure that may qualify him or her to participate in a study. When your child is seen in the clinic or doctor’s office or while your child is staying in the Hospital, a doctor, nurse or other staff member may ask you if you and your child would be interested in participating in a research study. You will be given an explanation of what the study is about and what will be expected of you and your child. Your child may need to take a medication and be available for examinations or special tests, or you may need to fill out a questionnaire or keep a journal.
Why should my child participate in a clinical trial?
When your child participates in a clinical trial study, the information obtained helps researchers understand about new treatments. This understanding may lead to new or more effective treatments that could benefit others with the same condition. This treatment may help your child or offer treatment choices that would not otherwise be available.
How do I decide?
It is important to ask questions. Your doctor or study coordinator will give you detailed information about the study. It may also help to talk to a family member, your doctor or your child’s pediatrician. Your study doctor or coordinator will review a form called the informed consent with you. This form contains important information about the study. The consent explains why the study is being done, what will happen during the study, and the benefits and risks of participation.
What happens if my child or I don’t want to be in the study?
If you or your child decides that you do not want to be in the study, your child will still be able to receive the usual treatments available. It will not affect the care your child receives at Rady Children’s.
Who will pay for the study costs?
In most studies, you are not charged for study medications or tests that are done just for the study. You may be responsible for standard tests. Some or all of the costs may be covered, depending on the study that your child is asked to be in. Some studies will also give the participants gift certificates or cash compensation. You should ask if you are responsible for any costs, including the visits, medications, devices, treatments or diagnostic tests.
Some points to consider before you or your child agree to participate in a clinical trial study:
- What is the purpose of the study?
- Who is the doctor in charge of the study, and how will I contact him or her during the study?
- What are my responsibilities during the study?
- What tests are required?
- How many visits are required?
- Where do the visits take place?
- What are the standard treatments available to me?
- Am I responsible for any extra costs?
- How long will my child be in the study?
- How will my child benefit from participating?
- What are the known risks involved?
- Can my child continue any other medications during the study?
- Will I find out the results of the study?