Questions to Consider

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Considering participation in a clinical trial, and the enrollment process itself, may produce a wide range of emotions. Hope to be accepted and for a good outcome is just the beginning. As a parent, you want to do anything possible to make your child’s life better. This sense of responsibility can make navigating the landscape of a clinical trial very challenging and sometimes emotionally painful.

The prospect of participating in a trial, whether it is new or ongoing, may raise your family’s hopes—and questions. What is the purpose of the trial? Will the goals and possible outcomes be what you are hoping for? Will your child meet the inclusion criteria and qualify to participate? If now, how will you feel? And will you be prepared to accept the outcome of the trial, no matter what it is?

As with so many decisions related to your child’s care, the more information you have, the better prepared and in control you will feel.

Your Team:

Primary Physician

A medical professional who practices general medicine.

Palliative Care Clinician

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.

Principal Investigator

The individual ultimately responsible for the overall conduct and management of the study.

Study or Research Coordinator

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 how participation might affect your family. Your parenting partner, if you have one, and/or trusted family and friends can help you identify topics and questions you will need addressed. Patient advocacy organizations have experience with trials and can help with your questions. 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.

You may worry at the prospect of being away from home for periods of time, of possible financial burdens, of other disruptions. You may also experience pressure from others who are eager to offer their opinions. But this is a very personal decision, with no right or wrong answers about whether to participate in a trial (or not).

You will undoubtedly have many questions about the specific trial you are considering. Examples of questions to ask can be found in the CPN guide “Evaluating the Clinical Trial Option: Questions to Consider.” There also are some more personal questions to ask of yourself, your family members, and the teams that care for you and your child. Accurate information, and as much of it as you can gather, is your roadmap to making a decision that works for your child and family. Always feel free to ask questions and to follow up on anything that you don’t understand.

Risks and Benefits

What are the possible benefits/results involved and how likely are they to occur?
What are the possible short-term risks or side effects and how likely are they to occur?
How do the risks and benefits of this study compare with those of other approved or experimental treatment options?
Are there any known prior results (efficacy and safety) of the treatment?
If my child participates in this trial, will they be eligible for future studies/trials or other treatments?

Finances

What study-related costs will be covered by the sponsors (e.g., travel, relocation services, childcare, etc.)?
Will my health insurance be utilized to cover any study-related tests or procedures?
Are there costs that I will have to pay to participate in the study?
How will reimbursement for out-of-pocket expenses, if I have them, work?
Who will cover the costs of treatment if my child has an adverse reaction or is harmed while participating in the study? Or while traveling to or from the study?
When the study ends, how will continuation of the treatment (if needed) be facilitated and how will it be paid for?

Care

What kinds of treatments, medical tests or procedures will occur during the study? How often will these be done?
Who will monitor my child’s care and safety during the study?
Will the results of tests or procedures be shared with me?
Will my child continue to see their current medical team, or will I need to switch their care to the center where the study is being conducted?
For how long after the study ends will the medical team/researcher continue to follow my child?

Lifestyle

What are the logistics of participating? (Will we need to live near the center where the study is taking place?)
What kinds of supports (financial, logistical, emotional) will be available to our family if our child participates?
How will my child’s siblings (if there are siblings) be supported during the study?

Values and Priorities

Is this the right study for my child, given their current medical condition?
What is my family’s goal for participating in this study? (Is it to improve my child’s short- or long-term prognosis? Is it to improve quality of life? Is it to contribute to the advancement of science?)
Am I willing to accept the risks associated with the study on behalf of my child?
What are the alternatives to participating in the study?
Am I willing to be away from my partner or other children if that is required?
Am I willing to accept that my child’s disease progression will likely be changed by the treatment/intervention in ways that no one can fully predict?
How will I feel if the trial is unsuccessful?
How will I feel if my child is not accepted because they don’t meet the study criteria?