Patient Concerns About Clinical Trials
Your health care provider may talk to you about your child joining a clinical trial.
Facing a new diagnosis of a serious illness can be frightening and overwhelming. Your health care provider may talk to you about your child joining a clinical trial.
It is normal to feel anxiety or confusion about what a clinical trial is and how it might affect treatment, prognosis, and quality of life. You may have many concerns and questions about the best treatment choice. Learning about clinical trials, sharing your concerns, and asking questions can help you decide if your child should take part.
What is a clinical trial?
A clinical trial is a research study that gathers information that may improve medical care. Some trials test new or different treatments. Others collect health information to help researchers better understand diseases.
There are 2 basic types of clinical trials:
- Therapeutic clinical trials may test new treatments or new ways of using accepted treatments that are usually used as standard medical care for a disease. These treatments may or may not be FDA-approved for your child’s illness or patient group. These treatments may also use standard FDA-approved treatments in a new way, or they may include a mixture of new and standard treatments.
- Non-therapeutic trials do not use new medicines or treatments. They gather information from things like medical records, patient surveys, and other data. This information may provide new insights into medical care or diseases.
The potential benefits, risks, and goals of each trial will depend on the type of trial and the patient’s medical condition.
The informed consent process
Before you decide whether your child should join a study, it is important that you understand:
- The possible benefits and risks of the trial
- How the trial fits with your family’s goals and values
Your research team will meet with you to discuss the research study and let you choose whether your child will take part. This is known as informed consent. This is also a chance to ask the research team about other options if you do not take part in the study.
Safety in clinical trials
Clinical trials today are conducted with strong safety measures in place to help protect patients and their families.
An Institutional Review Board (IRB) reviews and approves clinical trials to help protect patients. It is made up of independent experts, such as scientists, doctors, health care professionals, and community members. The review board:
- Considers the potential benefits and the risks to patients
- Approves the study
- Approves any patient-facing material or consent forms to make sure that participants are fully informed
- Monitors it
- Makes sure it meets acceptable ethical standards
Patients sometimes worry about being a “guinea pig” if they join a therapeutic clinical trial. Erica Sirrine, PhD, director of Social Work at St. Jude Children’s Research Hospital, says that anxiety is common.
“Being one of the first to try something new can be really stressful, and some people make the decision not to take part,” she says.
Questions about side effects
When enrolling in a clinical trial, people may be concerned about side effects, which can often be a long, frightening list on a consent form. But it is important to know that anything that happens to a patient during the trial is reported as a possible side effect.
Some things on the list may or may not be directly related to being in the trial. Side effects vary depending on the person and their medical condition. Some side effects may be more common, such as losing hair with chemotherapy. Other, more serious things may or may not happen, and some of the listed things could rarely happen.
You need to hear all the possible side effects to be fully informed. Ask your child’s care team what steps they would take if a more serious side effect happens. This will help you know what plans are in place to deal with problems that may arise.
“I try to reassure patients and families that while I don’t know exactly what’s going to happen, I know a lot about how this medicine works in someone else,” says St. Jude oncologist Seth Karol, MD.
“I don’t know for sure what the side effects will be for your child, and there may be some I don’t know about yet because we’re still learning. But I offer this treatment because I think there’s a chance it could help your child better than other things we could offer.”
Talking to the research team
Talking to your child’s providers about being in a clinical trial may seem frightening. But there are some things you can do to reduce fear and get the information you need to make a decision that is right for your child.
You can learn more about clinical trials, the steps of a clinical trial, and how patients are protected. You may want to write down:
- Your goals for short- and long-term care
- Why your child may or may not want to take part
- Your concerns about clinical trials
Take a friend or family member with you when you meet with the research study team. They can help you take notes. Be open and honest with the research team.
You may want to write down a list of questions to ask the research team about the clinical trial that your child may enroll in. These may include:
- Can my child take part (known as eligibility)?
- Is this a therapeutic or non-therapeutic trial?
- Will new treatments be given?
- What is done to protect my child’s safety?
- What are the possible side effects?
- What will be done to deal with side effects if they happen?
- What are the benefits and risks?
- What will be done to protect my child’s privacy?
- What is the financial cost of being in the trial?
- What will my child have to do in this trial (clinic visits, testing, or treatments)?
- Can my child quit the trial at any time, and what happens if they do?
Weighing the time commitment
It also helps you to think about what you can commit to if your child takes part in a clinical trial.
“One of the things that makes being in a clinical trial a little more challenging than the regular, standard treatment is the timing of the treatment, schedule of the visits, and medications,” Sirrine says. “Patients and families have to be willing to commit to a little more structure.”
Balancing opinions
Another important thing to think about is an individual patient’s prognosis.
“Some families may need to weigh if they want to try a new treatment, hoping it helps, or prioritize other things that impact their quality of life,” Sirrine says.
Your friends and family members may have different opinions about what you should do. You may have concerns about what they think and how to talk to them. In such cases, reach out for help from health care professionals, counselors, or chaplains and spiritual advisers. They can help.
Support as you make your decision and participate
Health professionals who may be available to help you through this experience include:
- Your doctor and the research study team
- Social workers
- Psychologists
- Child life specialists
- Chaplains and spiritual advisers
- Research participant advocates: They are not part of the research team but can talk to you and providers about problems, concerns, or questions.
If there is no support professional available for the clinical trial you are participating in, you may consider contacting groups that support treatment for your disease. They may be able to direct you to someone who can help.
It is OK to ask the research team what their biggest point of concern is for your child’s case. Get complete and accurate information directly from them to make the best decision. Do not rely just on online information. Sometimes online information may be inaccurate or does not consider your child’s medical situation.
Honestly sharing your concerns, asking questions, and knowing what you value will help you better navigate important treatment decisions. Your conversation with the study team is a chance to build a partnership.
“I really enjoy consent discussions, because it’s all about building the relationship with the patient,” Karol says.
Clear communication matters
Some people may come from a cultural background in which patients and families do not ask health care providers questions. If this is true for you, it may be hard to do this at first as you learn to be your own advocate. A cultural navigator may be available at your health care center who can help with language and communication so you can get the information you need and express your concerns. If a cultural navigator is not available, you may try asking a social worker, chaplain, or interpreter at your health care facility for help.
Another good thing to do is to tell the research team what you understood from the conversation. This way, they can clear up any misunderstandings you may have.
If you would like to have some time to think about everything before you make your decision, ask your providers when they need your decision. Some people want to talk to others in their support network, pray, or read more about their illness or treatment before they decide. Let the research team know if you need a little more time to decide.
If you need help as you consider and take part in clinical trials, you may be able to reach out to organizations that offer patient navigation. These include:
Learning about the clinical trial, asking questions, and sharing concerns are important first steps in building a good relationship with your child’s health care team, and can help you make a decision that is right for you and your family.
