The week of May 2, 2016 marks the second annual Clinical Trials Awareness Week. During this week, national and local patient advocacy organizations, medical societies, research institutions and others join the Coalition for Clinical Trial Awareness to raise public awareness about the benefits of clinical trials. As part of an academic medical center, CHoR recognizes the important contributions of the many clinical trial researchers and participants here and at other institutions who have made new and innovative treatments a reality for patients worldwide.
To help raise awareness and educate families about research and clinical trials, CHoR’s Vice Chair for Clinical Research Dr. Henry Rozycki put together the following checklist of questions for parents considering enrolling their child in a clinical trial. He also addresses common questions about clinical trials – from recent breakthroughs at CHoR to where to find out more about participating – in his educational series on this important topic. Join us in celebrating Clinical Trials Awareness Week by learning more about clinical trials and how they help advance scientific research and patient care.
As a parent, it is very likely that at some point you’ll receive information about the opportunity to enroll your child in a clinical trial or research study. Clinical trials study new and promising treatments for serious illnesses like cancer or chronic conditions like allergies, while research studies focus on gathering information for analysis. Whether you have a child experiencing a medical issue and your child’s doctor approaches you about participating a trial, or information comes home in your child’s backpack seeking participants for an upcoming study on childhood nutrition, here are some important things to consider before agreeing to allow your child to participate. (Blog post originally appeared on Advancing Children’s Health in January 2016.)
Understanding trials and research studies
Investigators conduct clinical trials and research in hopes of better understanding childhood diseases, discovering new methods that improve care and outcomes, and finding cures for illnesses. Trials begin after preliminary research has shown that a potential new treatment is effective. Eligible patients who choose to participate in a trial may receive new drug or try new procedures or treatments before they become widely available. Most trials also include a group who receive the current best treatment available. All trials/research studies are voluntary and any information collected as part of a trial or study is kept confidential.
Results from clinical trials and research studies are meant to help children in the future. Participation may also help your child, but it may not, and it is up to the parent whether a child participates. The best way to make that decision is to get as much information as you can about your child, their illness and the trial/study itself so you can make an informed decision (referred to as informed consent). Below is information to help guide you through this decision.
To decide whether a child should participate, it may be useful to ask several questions:
✓ What makes my child a good candidate for this trial/study?
✓ What would be the potential benefits to my child, especially compared to what the current treatment my child is receiving?
✓ What would be the potential risks/ side effects? Not just during the trial but afterward? How likely are both the benefits and the risks?
✓ What exactly will happen during the trial/study in detail? Will my child possibly receive new medication? Would they possibly receive their current medication or a placebo (a fake treatment that has no effects)? What tests will occur? Will they be done in the hospital or in the office? Where will the study be done?
✓ How long will the trial/study last?
✓ Is there any cost involved? Will my insurance be billed for expenses not covered by the sponsor? (This is worth asking but the answer should be that it will cost you nothing.)
✓ What is the time commitment involved in participating? What does participating in the trial involve in terms of additional trips to the doctor’s office, visits to hospital, etc.?
✓ Who is in charge of the trial/study and who can I contact about the trial/study and what is happening to my child throughout the trial/study? Who is overseeing the trial/study both locally and overall?
Note: You should get this information in writing.
✓ Who do I contact if I have a concern?
Note: If your child is participating in a study at CHoR, both the doctor in charge of the trial as well as the Office of Human Subjects Protection at VCU are available to assist with concerns. (The Office of Human Subjects Protection at VCU can be reached at (804) 828-0868.) Similar contacts should be available at other institutions you are working with.
✓ Will I be able to get results from the trial/study, either during or after it is completed?
✓ What happens when it’s over, especially if my child has done better during the trial? Will my child continue on the investigational treatment if it’s working well?
Participating in a clinical trial or research study can be good for your child and helpful to children in general, but it also may not, and there may be risks. It is ultimately your decision whether your child participates or not. Gathering as much information as you can is recommended and questions like the ones listed above can help guide you though this process.