Clinical Trials FAQs
What Is A Clinical Trial?
A clinical trial is a research study where human volunteers receive a new medical intervention -- a drug, device or procedure -- to test if the new intervention is safe and effective.
Are There Risks to Participating in a Clinical Trial?
There may be risks associated with your child’s participation in a clinical trial. The new drug, device or procedure has been tested in the lab and may have been tested in animals to determine how much risk might be involved. Some side effects may be known but some may be unknown. Each child may react differently to a medication or procedure. Also, your child may have to come off his or her usual medication and there could be a risk associated with that. All known risks will be described in a document called an informed consent form. You will be provided with this form.
What Is a Research Protocol?
Clinical trials follow a very carefully planned set of procedures and are described in a document called a protocol. Before patients can be enrolled in a study, the protocol must be reviewed by a panel that includes doctors as well as other members of the community. Any changes to the protocol must also be reviewed and approved by this panel before they can be made.
Are There Benefits to Participating in a Clinical Trial?
There is no guarantee that your child will benefit from participating in a clinical trial. With a new study medication, you may find that your child’s condition is better controlled or that he or she is experiencing fewer side effects. But this may not occur. Clinical trials sponsored by pharmaceutical companies often provide free medication and study-related care. There are many reasons why parents enroll their children in clinical trials. Often parents say that they want to help other children with the same disease or disorder.
What Is Informed Consent?
You will be told about the study, including any possible benefits and any known risks, before you decide if a clinical trial is right for your child. In addition, the informed consent will explain what will happen during the trial, how long it will last, how often you will be asked to come to the hospital and how long the visits will last.
You will be given the opportunity to ask your doctor any questions about the trial.
Participation in a clinical trial is voluntary. Only you can decide what is best for your child. No matter what you decide, your child will continue to receive the same high-quality medical care from his or her doctors and nurses. There is no right or wrong decision when it comes to enrolling in a clinical trial.
Before being enrolled in a clinical trial, you will be asked to sign an informed consent form. You may change your mind at any time. Should you decide to withdraw your child from a clinical trial, he or she will continue to be treated by his or her doctor, without prejudice.
Who Pays for a Clinical Trial?
Clinical trials are sponsored by government agencies, universities, medical centers, pharmaceutical companies and device manufacturers.
Are There Special Protections for Patients in Clinical Trials?
Clinical trials are carefully regulated and are governed by clearly defined legal and ethical codes. The Food and Drug Administration (FDA) made it a requirement that all clinical trials be reviewed and approved by a panel called an Institutional Review Board (IRB). The IRB is made up of a voluntary group of experts and community members who evaluate the potential benefits and risks associated with a trial before patients can be enrolled. The primary goal of the IRB is to protect the public. The phone number for the Children’s Hospital Los Angeles IRB will be provided on the informed consent form. Contact them if you have any concerns about your child’s treatment in clinical trial.