Eligibility
Clinical trial is a medical term for a controlled experiment designed to address questions about a condition or disease. It is research or an investigation that explores whether a medical strategy, treatment, or device is safe and effective (and has positive benefits) for humans.
Trials are carefully designed for this purpose, and the detailed plan for the trial is called the protocol. One important part of the protocol is the list of characteristics or factors that a participant must meet or be able to participate in the trial. These are called the eligibility criteria, and they are different for every trial. They are used to identify appropriate participants for a safe trial. They help minimize risks and maximize success of the trial, by identifying a group of patients who are most likely to show a measurable benefit from the treatment.
Your Team:
A medical professional who practices general medicine.
A specialist whose aim is to improve the quality of life of their patients over the course of their illness regardless of stage, by relieving pain and other symptoms of that illness.
Professionals who have completed advanced training in a specific area of medicine.
The individual ultimately responsible for the overall conduct and management of the study.
The person responsible for the day-to-day management and coordination of research studies.
Your child’s primary physician and palliative specialists can help you think through your questions to ask about the trial and whether your child would be an appropriate candidate for inclusion. Specialists on the medical team can help you determine whether your child is likely to qualify for the trial. Patient advocacy organizations can provide helpful information about the trial. The trial’s Principal Investigator and Study or Research Coordinator are there to explain the risks and benefits, and to answer your questions. They will support you through the enrollment process if you decide to proceed.
Eligibility for a trial is often the first emotional hurdle for many families. You may be eligible and accept; you may be eligible and find that trial participation is not right for your child and family. It also may be that the criteria for participation does not match your child’s condition. Although it is natural to feel disappointed, your child being excluded does not mean that you have not been a good parent or advocate. It is also important to remember that each trial is unique and will have its own eligibility criteria so participation in a different trial may be possible.
