Is a clinical trial right for me?

Questions to ask when thinking about taking part in a clinical trial

Facts about the study

• What is the purpose of the study?
• Who is running the study?
• Who is paying for the study?
• Who has reviewed and approved the study?
• Who reviews the results?
• What treatments may I receive
• Does the study use a placebo (dummy treatment)?
• Why do doctors believe this new treatment may work?
• How will safety be monitored?
• How will the results be shared?
• How will the study keep my name and records private?

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 options for treatment do I have?
• How do the pros and cons of my other options compare with those of the study?

What the treatment will involve

• How long does the trial last?
• How often do I need to come to the clinic?
• How many times a day will I have to take the drug?
• What other things do I need to do?
• How is the drug given - as a pill, in a shot, or in another way?
• What tests do I need to take?
• Am I able to see all my test results?
• Who treats me in the study?
• Do I see the same doctor or nurse each time?
• Can I keep seeing my own doctor?
• Where will I be treated after the study?
• What happens if the treatment makes my health worse?
• If I take a drug that helps me, can I keep taking it after the study is over?

Personal issues and support

• Can I talk with people already enrolled in the study before I decide to take part?
• How could being in the study affect my daily live?
• What support is available for me and my family?
• Does a social worker (or other trained person) provide support and help me deal with problems?

Costs

• What costs are covered by the trial?
• What other costs can I expect?
• What help with costs is available?

Questions to ask yourself

• Is helping to find better treaments important to me?
• Can I accept the changes a trial may make in my daily life?
• Am I committed enough to
  • Take the drug as often as I should?
  • Go to the clinic as needed?
  • Stick with the trial as long as it lasts?
• Am I willing to follow all of a trial's policies?
• Are the pros of taking part greater than the cons?
• Do I have the support of my friends and family?

Updated: 12 August 2008

Based on ' AIDS clinical trials: Talking it Over' NIH and 'Facts About Clinical Trials in Vision Research', National Eye Institute