Questions to Ask the Study Team
Before enrolling in a study, you should obtain answers to the following questions. If you cannot find answers to these questions on the consent form, ask the study investigator or coordinator.
- What is the primary purpose of the study?
- Why do researchers believe the new treatment being tested may be effective? Has it been tested before? Where? And, if so, for how long?
- What is known about the medication’s effectiveness and safety in other countries?
- What are the possible risks, side effects, and benefits of the clinical trial, and how do they compare with my current treatment?
- Who will be participating in the study?
- What kinds of medical problems would prevent participation in the clinical trial?
Insurance and Reimbursement Questions
- 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 your condition?
- What is the likelihood of the company having the resources to obtain FDA approval and provide an adequate supply of the medication once it is approved?
- What other medications has the company studied and/or brought to market? What is the company’s track record?
- Will I (or my health insurance company) have to pay for any part of the study?
- Should I inform my health insurance company before enrolling?
- What assistance will the sponsor company provide in terms of transportation or hotel accommodations?
- What medical tests, office visits, and treatment costs will be covered during the clinical trial?
- Who will be in charge of my care?
- What type of screening is involved?
- How many times will I have to visit the study center and see the study doctor?
- If I have an episodic condition, when should I contact my physician? At the onset, or after a waiting period?
- What treatment(s) are involved?
- What if I miss a dose?
- Is there a chance I will be receiving a placebo instead of the new treatment? Will I know if I am receiving the placebo? Will my doctor?
- 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?
- Does the study allow for additional treatment dosages if the first dose does not bring you rapid relief?
- What does the protocol allow if I am having a painful or life-threatening attack?
- If I am currently taking other medications(s), should I continue taking these medications?
- How might this trial affect my daily life?
- How long will the trial last?
- Will hospitalization be required?
- What type of long-term follow up care is part of this study?
- How will I know that the treatment is working?
- How will my safety be monitored? What happens if the treatment causes me harm?
- Will results of the trials be provided to me? If so, when?
- Can I drop out of the study at any time?
- Can I choose to remain on this treatment, even after the trial ends?