Considerations for participants

It’s important that you discuss any questions and issues with the members of the research team and your usual health care provider.

Anyone considering participating in a trial should consider the risks, and potential problems and benefits.

Risks

• There is no guarantee of personal benefit from the trial.
• There may be negative side effects or adverse reactions to medications or treatments that may make your health worse.
• The treatment may not work well for you.

Potential problems

• You may not be able to take part in other trials.
• You may not know who is receiving the drug under study versus a placebo.
• You may have to make some lifestyle changes, such as not eating certain foods or avoiding some types of daily activities.
• You may have to stop taking other medications that are working well.

• You may need to go to several appointments, have more tests, or keep a daily clinical trial diary.

Potential benefits

• You are taking an active role in your own health care.
• You might be gaining access to treatments under study that are not available to the general public.
• Your participation may help in the development of new treatments and help others in the future.
• You may receive regular health monitoring that is part of the trial.

Questions to ask

Anyone interested in participating in a clinical trial should know as much as possible about the study and feel comfortable asking the research team questions about the study, the related procedures, and any expenses. The following questions may be helpful during such a discussion. Answers to some of these questions may be provided in the informed consent document provided to participants. Many of the questions are specific to clinical trials, but some also apply to other types of studies.

• What is being studied?
• What is the phase of the study?
• Who is going to be in the study?
• Why do researchers believe the intervention being tested might be effective? Why might it not be effective? Has it been tested before?
• How is the treatment different from the current therapies or standard of care?
• What are the possible interventions that I might receive during the trial? How will you determine which intervention I receive? Who will know which intervention I receive during the trial? Will I know? Will members of the research team know?
• What are the requirements to be part of the study? Do I qualify? What sort of tests will be done to determine if I qualify for the study?
• How do the possible risks, side effects, and benefits of this trial compare with those of my current treatment?
• What will I have to do?
• What tests and procedures are involved?
• How often will I have to visit the hospital or clinic?
• Will hospitalization be required?
• How will this affect my daily life?
• How long will the study last?
• What is the treatment schedule?
• Who will pay for my participation?
• Will I be reimbursed for other expenses?
• What type of long-term follow-up care is part of this trial?
• If I benefit from the intervention, will I be allowed to continue receiving it after the trial ends?
• Will results of the study be provided to me?
• What happens when the clinical trial ends?
• Who will oversee my medical care while I am participating in the trial?
• What are my options if I am injured during the study?
• Who can I talk to if I have any concerns about my treatment?
• Will participating in this clinical trial prevent me from participating in other clinical trials in the future?