Some Questions to Ask About the Trial and About the Drug

1. Will I have to stop taking drugs previously prescribed for me and for how long?

2. Has this drug been used before? For what conditions? What were the results?

3. What other drugs are being used for this condition? How does the trial drug compare in safety and success? What is the evidence that this substance can treat my condition? What are the immediate side effects of this drug? What are the long-term effects of my using this drug?

4. If I have any side effects, how will I be helped to deal with them?

5. What type of drug is being tested?

6. How often must the drug be taken? How will the drug be given in this trial? Pills? Intravenously? By shot?

7. Must the drug be taken in the hospital? Do I have to take the drug at the trial site, or can I take the drug at home?

8. How will taking the drug affect my day-to-day activities?

9. Is this drug available outside of this trial? If so, how can I get it?

Informed Consent

1. What tests will be given before I start? Will these tests cost anything? Will I get the results of these tests?

2. What tests will be given during the trial? How often? Will I get the results of these tests? When?

3. How often will the researchers tell me how I am doing while I am in the trial?

4. Is this trial confidential? Will anyone outside of the trial know about my health condition without my permission?

5. How will this trial about me be coded to protect my privacy? How will genetic information about me be handled, and what control will I have regarding who may or may not have access to it.

6. Do the consent papers that I am signing describe all of the risks and benefits of my participation in the trial?

7. Will I have the same response from the trial drug as the previous one which I discontinued before entering the trial?

8. What written information will I be given about the trial and the drug?

9. How often will the Institutional Review Board (IRB) review the trial for any changes?

10. How will I be informed of those changes? If this trial changes significantly, or if I’m put into another trial, will I receive an updated informed consent form to sign??

11. Do I need to have my own doctor to get into the trial?

12. Do I need health insurance to be in the trial?

13. Do I have to pay for lab tests or any other costs?

14. If I experience side effects requiring emergency room treatment, which hospital can I go to and who pays for the treatment?

15. Will I be given any money for participating in the trial?

16. Will the money be reportable to the IRS?

17. Will I be reimbursed for travel expenses to and from my visits?

18. If I am caring for a child is child care available?

19. Will the sponsors of the drug supply it to me free until it is marketed and available by prescription?

20. If I develop health problems as a result of being in the trial, will treatment be available to me even if I leave the trial before it is over?

Food and Drugs

1. If the drug is a pill or capsule, should I take it on an empty stomach? With food?

2. Are there any special foods that I need to eat while in this trial? If I am already on a special diet, may I continue?

3. Are there any foods or other substances that I shouldn’t have while taking this drug?

4. Can I drink alcohol? Can I take any over-the-counter (nonprescription) drugs? Aspirin? Cold tablets? Cough syrup? Herbal remedies?

5. Can I use prescription drugs while I am in this trial? Can I use other experimental drugs?

6. Can I take drugs to prevent or treat opportunistic infections, cancers, or any other illnesses I may get?

7. What type of contraceptives can I use Do I have to use contraceptives? Are oral contraceptives permitted? Will my use of contraceptives be monitored? Are pregnant women allowed in the trial?

Leaving the Trial

1. If my condition gets worse while I am on the drug, will I be taken out of the trial?

2. If I am in a placebo group, can I get the drug if my condition gets worse during the trial?

3. If the trial was successful, can I take the drug once the trial is over? If the drug worked for me, can I continue to take the drug even if the trial was declared a failure?

4. How is the success of this trial defined by the protocol?

5. How will decisions about stopping the trial be made? How is failure defined in the protocol?

6. Will my health continue to be checked after I stop taking the drug? Will this be done even if I decide to leave the trial?

7. Will there be long-term follow-up on how I am doing? Will this be done even if I leave the trial before it is over or if the entire trial is stopped early by the researchers?

8. How can I find out the results of the trial? Will I be able to participate in future trials of this drug? Will I receive the results of future trials using this drug?