Second Edition

By Tracy Swan and Matt Sharp

January 2013 – There are many new hepatitis C drugs being studied in clinical trials. People with hepatitis C have many options to choose from. Whether you have hepatitis C or another medical condition, deciding to participate in a clinical trial can be complicated. Having more information can help you decide whether or not to participate in a clinical trial, and which trial, or trials, may be right for you.

Some people are comfortable with a doctor’s recommendation, while others prefer to make their own decisions about whether to participate in a clinical trial, and which trial is best for them. If you want to look for clinical trials or find out more about them, information is available online at www.clinicaltrials.gov.

The information in this guide is important because:

• People who participate in clinical trials are putting their bodies on the line. Regulations to protect trial participants vary from country to country. This guide was written in the United States, where there are federal regulations and guidelines to protect people from unreasonable risks during clinical trials. Trials in the European Union must follow the European Commission’s Clinical Trials Directive, available online at: http://ec.europa.eu/health/human-use/clinical-trials/index_en.htm#rlctd. Despite these safeguards, some risks are unavoidable when new treatments are being studied.
• If you decide to participate in a clinical trial, you should have information about all possible risks and benefits, so you can make the best choice for yourself.
• You need to feel comfortable asking questions and discussing all of your concerns with the research team.
• Most doctors have the best interests of their patients in mind, but some are paid to recommend, enroll, or refer people to trials. Learning about all your options can help you make the best decision for yourself, so it’s always a good idea to ask what your doctor would recommend if you decide not to participate in a clinical trial. Sometimes it can help to get a second opinion from a doctor who is not involved in the trial.
• Some trials are riskier than others. For example, a clinical trial of a drug that has never been used in human beings may be riskier than a trial looking at how long to treat people with drugs that have already been approved.

The risks and benefits of enrolling in a clinical trial may depend on the type and stage of your hepatitis C, the drug or drugs that are being studied, as well as personal considerations.

This guide has eight sections:

Section 1. About Clinical Trials

Section 2. About Hepatitis C

Section 3. About Hepatitis C Treatment

Section 4. About Drug Resistance and Treatment Adherence

Section 5. About Side Effects

Section 6. About New HCV Drugs and Treatment Strategies

Section 7. Deciding to Participate in a Clinical Trial

Section 8. Questions