It is important for people to ask questions before deciding to enter a clinical trial. Here are some questions patients might want to ask their doctor or nurse.

The Study

• 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 occur during the study? How often will patients 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?

Personal Issues

• How could being in the study effect the participants’ daily lives?
• What support is available for participants and their families?
• Can potential participants talk with people already enrolled in the study?

Cost Issues

• 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?