Questions to ask your Clinical team

The following section was created using several sources of information considered as reliable and transferable for CDG. The goal is to facilitate a list of core questions about clinical trials that you may want to consider in your next medical appointment. 
When you decide to participate in a clinical trial it is very important that you are informed and aware of your decision. It is essential that you trust the team that will accompany you and that you understand the whole process.

When you decide to participate in a clinical trial it is very important that you are informed and aware of your decision. It is essential that you trust the team that will accompany you and that you understand the whole process.

You can ask the healthcare team the following questions about clinical trials (research studies). Choose the questions that fit you, or your child’s, situation the most and add questions of your own. You may find it helpful to take the list for the next appointment and to write down the answers.

Below are some questions to include:

Watch the video on Questions to Ask Before Volunteering in Clinical Trials that the U.S. Department of Health and Human Services has made available here to learn more. 

The Study

• What is the purpose of the study? (see more information on Understanding clinical trials or considering a clinical trial section)
• Has this type of treatment ever been tested before?
• What does the study involve?
• How long will the study last?
• What kinds of medical tests, procedures or treatments are done during the study?
• How often and for how long is the study treatment given?
• If the treatment is not working, is the trial stopped?
• How many phases will the clinical trial have and how will they be?
• How is a participant’s safety checked?

Participation and Care 

• What type of care will be given?
• Who will be in charge of my care? Will I be able to see my own doctor?
• Can people in the clinical trial meet and talk with one another?
• Are there any consequences of dropping out of the study?

Personal Issues

• Are there any activities or other treatments that cannot be done during or after this study?
• Should a family member or friend come with me to my treatment sessions?
• What kind of support from my family and friends will I need?

 Cost Issues

• Who sponsors this clinical trial?
• Will the study require extra time, work or expenses? Will I be reimbursed for my expenses?
• Can the trial be done here or do I need to travel to another center? Are travel costs and expenses covered?

Risks involved 

• Is there any pain or other side effects associated with the therapies, tests or procedures? If so, how severe, and how long will the pain or side effects last? How can I best control side effects while I am participating in the trial?
• How do these compare with standard treatment or approaches?
• What side effects may happen during or between my treatment sessions?
• Are there any side effects that I should call you about right away?
• How can I prevent or treat side effects?
• What will happen if my condition gets worse or if I am injured?

Benefits 

• Compared to other studies, what benefits can I expect from this?
• What expectations should I have about this clinical trial? What improvements can I expect?

Privacy and Confidentiality 

• Will the results obtained be disclosed?
• If the results are published will my data be protected?

Additional Considerations

• Can I have access to the study before its publication to check if I agree with the way my data (records, photos, reports) were approached ?

After the trial

• Are there any lasting effects of the treatment?
• Will there be any follow-up after the study? For how long?
• How long will it be before the results of the trial are known?
• What happens after the study is over? Will the results be shared?

The BMS Study Connect has made available an educational resources that gives “An overview of your journey through a clinical trial and Questions” that you might have for your study team. Read more here. 
 
The Office for Human Research Protections has created a list of questions that you should ask the medical team that will accompany you through
 the clinical trial. Download a printable PDF here.
 
For further reading:
 
If you want to know more about this topic we leave below a list of links where you can find different approaches:
 
The Canadian Cancer Society prepared this set of Questions to ask about clinical trials that you can ask your healthcare time. 
 
On the website of National Cancer Institute (USA) you will find a very complete list of Questions to ask your Doctor about your treatment, divided into several topics that you should ask the medical team.
 The American Academy of Pediatrics has a section dedicated to the theme of clinical trials involving children, Should my Child join a Clinical Trial? On this website you will find a very complete approach to the various issues involved in a clinical trial: the objective, the procedure, the possible benefits and risks. You will also find a glossary with some terms used by researchers and other professionals involved in the clinical trial.
 
The Office for Human Research Protections offers a printable PDF document Questions to Ask about volunteering for a Research Study. You will find not only a checklist of  questions to ask the medical team that will accompany you, but also a glossary with terms that can be useful.
 
Participating in research is a booklet developed by Seattle Children's of the Hospital Research Foundation to answer questions about childhood health and the implications of children participating in clinical trials.
 
The SANOFI developed a Clinical Study Guide and WebMD created Clinical Trials: A Guide. This two guides are directed for people who are thinking about entering a clinical trial , raising questions and aspects to be aware of when we take this decision 
 
 

Author

Eva Dias Sci and Volunteer Program Nova School of Science and Technology 2021. 

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