It is important for people to ask questions before deciding to enter a clinical trial. Questions people might want to ask their doctor or nurse include the following:
- What is the purpose of the study?
- Why do the researchers think the approach being tested may be effective? Has it been tested before?
- Who is sponsoring the study?
- Who has reviewed and approved the study?
- What are the medical credentials and experience of the researchers and other study personnel?
- How are the study results and safety of participants being monitored?
- How long will the study last?
- How will the results be shared?
Possible Risks and Benefits
- What are the possible short-term benefits?
- What are the possible long-term benefits?
- What are the short-term risks, such as side effects? What are the possible long-term risks?
- What other treatment options are available?
- How do the possible risks and benefits of the trial compare with those of other options?
Participation and Care
- What kinds of treatment, medical tests, or procedures will the participants have during the study? How often will they receive the treatments, tests, or procedures?
- Will treatments, tests, or procedures be painful? If so, how can the pain be controlled?
- How do the tests in the study compare with what people might receive outside the study?
- Will participants be able to take their regular medications while in the clinical trial?
- Where will the participants receive their medical care? Will they be in a hospital? If so, for how long?
- Who will be in charge of the participants’ care? Will they be able to see their own doctors?
- How long will participants need to stay in the study? Will there be follow-up visits after the study?
- How could being in the study affect the participants’ daily lives?
- What support is available for participants and their families?
- Can potential participants talk with people already enrolled in the study?
- Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate charges be?
- What is health insurance likely to cover?
- Who can help answer questions from the insurance company or health plan?