Questions to Ask the Study Team

Before enrolling in a study, you should have answers to the following questions. If you cannot find answers to these questions in the Consent Form, make sure to ask the research study investigator or coordinator.

• What is the primary purpose of the study?
• Who is sponsoring the study?
• What is the experience of the sponsor company?
• Are they a new company? Or do they have a long history with HAE or other medications?
• Why do researchers believe the new treatment being tested may be effective? Has it been tested before? Where? And for how long?
• Is the study medication approved in other countries? If so, how long has it been used in those countries?
• Who is going to be in the study?
• What kinds of medical problems would prevent participation in the clinical research trial?
• Will I (or my health insurance company) have to pay for any part of the study?
• Do I have to talk to my health insurance company before enrolling?
• Who will be in charge of my care?
• What type of screening is involved?
• What kinds of tests will I need and do any require blood samples?
• How many times will I have to visit the study center and see the study doctor?
• Should I contact the physician as soon as I’m having prodromal symptoms? Or should I wait for a full attack?
• If I’m having an attack and I’m too uncomfortable (or unable) to drive, will the study sponsor provide transportation?
• What treatment(s) are involved? Are any painful shots required?
• What if I miss a dose?
• Is there a chance I will be receiving a placebo instead of the new treatment?
• Will I receive medication even if I’m in the placebo group? What is the duration of time between receiving the placebo and receiving the treatment?
•  What does the protocol allow if I am having a painful or life-threatening attack?
• Will I know if I am receiving the placebo? Will my doctor?
• What if I'm on other medication(s) from my regular doctor? Can I continue these? Should I?
• What are the possible risks, side effects, and benefits of the clinical research trial, and how do they compare with my current treatment?
• How might this research trial affect my daily life?
• How long will the research trial last?
• Will hospitalization be required?
• Will I be reimbursed for travel expenses such as gas, parking, transportation, hotel accommodations, or tolls?
• What type of long-term follow up care is part of this study?
• How will I know that the treatment is working?
• How will your safety be monitored?
• Will results of the research trials be provided to me? If so, when?
• Can I drop out of the study at any time?
• What happens if the treatment causes me harm?
• Can I choose to remain on this treatment, even after the research trial ends?