Questions to Ask

This section reviews questions to ask yourself, your healthcare providers, and the study team when deciding whether to participate in a clinical treatment trial.
 
Although research studies can provide a lot of valuable information about conditions, not everyone with the same condition will be eligible to participate in every study, and it may not be in someone’s best interests to participate in any particular study.  It is important to consider participation very carefully and, if you do consider participating, you should make sure you understand the purpose of the study and what your role will be.

How do I decide whether to participate in a clinical treatment trial?

Deciding whether to participate in a clinical treatment trial can be difficult because there are both positive and negative aspects to every study. The decision will not be the same for everyone. When trying to decide, first ask yourself and your healthcare providers some basic questions:
  • Why do I want to take part in a clinical trial?
  • What are my goals and expectations if I decide to take part? How realistic are these goals and expectations?
  • How sure are my doctors about what the future holds if:
    • I decide to participate?
    • I decide not to participate?
  • Have I considered:
    • The chance of benefit versus risk?
    • Other possible factors, such as time, money, emotional effects, and impact on my family?
    • My other possible options?
Some of these questions may not have clear-cut answers, but they should help you start thinking about some important issues. Each person's situation is unique, and each person's reasons for wanting or not wanting to take part in a study may be different.
Adapted from www.cancer.org

Questions you might want to ask the study team include the following:

  • What is the purpose of the study?
  • Why do the researchers think that the approach they are testing might be effective?
  • Has this test/intervention/treatment 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?
  • Does the study have control and treatment groups?
  • How are the study results and safety of participants being monitored?
  • Is there a plan for the researchers to look at the data during the study to see if there is a benefit of the treatment, and if so, how will that be managed?
  • How long will the study last?
  • How will participants be kept informed of the trial status and when will the results be available?
  • Will participants have access to the treatment once their part in the trial is over and while they are waiting for the results to come out?

Possible Risks and Benefits

  • What are the possible short-term benefits?
  • What are the possible long-term benefits?
  • What are the possible 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?
  • Will the participants be monitored after the study for potential risks and long term benefits?

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, 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?
  • Will there be information for the patient’s regular primary care doctor?

Personal Issues

  • 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 it be easy to call and ask the study team questions between clinic trial visits, and is this encouraged?
  • Will the study team give out emergency numbers to use in case there are issues or complications, or if participants have questions over the weekend?

Cost Issues

  • Will participants have to pay for any treatment, tests, or other charges? If so, what will the approximate costs be?
  • What is health insurance likely to cover?
  • Who can help answer questions from the insurance company or health plan?
Adapted from http://www.cancer.gov/cancertopics/factsheet/Information/clinical-trials
Document adapted from Duchenne Connect written by Holly Peay (Parent Project Muscular Dystrophy)