Tips to Help You Prepare

When you are considering whether to join a clinical trial, feel free to ask as many questions as you need. Before the clinical trial begins, you will meet with the study's cystic fibrosis doctor or research coordinator to learn more about the trial.

Here are some tips to help you prepare:

• Write down your questions ahead of time and bring them to the meeting.
• Bring a family member or friend to your appointment to help you feel more comfortable when talking with the CF doctor or research coordinator. They may ask other questions that will help you decide about participating.

In this video, Olivia, an adult with CF, talks about her experience participating in a clinical trial.

Suggested Questions

Part of the informed consent process is comprehension, so if you do not understand something, ask! The research team expects that you will have questions for them, so do not worry about bothering them or asking a “stupid” question. If you are not sure what to ask, here are some suggestions:

Study purpose, risks, and benefits

• What is the purpose of this study?
• Why do you think I am a good candidate for this study?
• What are the potential benefits of participating in this study?
• What are the potential risks to me if I participate?
• How many people will be in the study?
• How does the study drug/therapy work?
• How is the study drug administered? (e.g., inhaled, oral, injection)
• Do I need to change any of my other treatments?

Safety

• Who has reviewed and approved the study?
• How will my safety be protected during the study?
• Will I be able to see my own data during the study?
• Who else will have access to my data and/or samples?
• What will happen if I get sick during the study?
• Who do I contact if I am not feeling well or have questions during the study?
• Can I quit the study?

Time commitment and other logistics

• How long will the study last?
• How many study visits are there, and how much time will each visit take?
• What tests or procedures will I have to do?
• Can I talk to other people who are participating in the study?
• Who is paying for and supporting the study?
• Will I be compensated for my time?
• Will I be reimbursed for study-related expenses? (e.g., mileage, parking, meals, etc.)
• Will results of the clinical trial be given to me and, if so, when?
• If I am responding well to the treatment, can I continue with the therapy after the study ends?

Genetic Therapy Trials

Clinical trials for genetic therapies may pose risks and benefits that are different from other CF clinical trials. Before enrolling in a genetic therapy clinical trial, consider asking these questions:

• Can you explain what is known about my genetic mutations?
• Will this treatment last forever, or will I have to repeat it?
• Which parts of my body will be affected? (e.g., lungs, other organs)
• Will this treatment reverse my existing lung damage?
• How is this treatment different from taking a modulator?
• I am thinking of having a baby in the future. How will being in this study affect that?
• If I participate in this study, will I be able to enroll in future gene therapy studies or other clinical trials?
• Will this treatment affect my DNA or other genes?

To learn more about genetic therapies, watch this video which explains gene therapy, gene editing, and RNA therapy.