1. WHAT SHOULD I THINK WHEN ASKED TO BE IN A CLINICAL TRIAL? Robert L Page II, PharmD, MSPH Professor University of Colorado Schools of Pharmacy and Medicine

2. What Happens Before a Clinical Trial Starts Pre-clinical or laboratory studies Completion of an Investigational New Drug Application Pre-clinical studies Manufacturing information Clinical protocols and investigator information

3. Facts About Clinical Trials To Keep in Mind Taking part in any trial is voluntary (you can leave a study at any time). You must give your consent to be a part of a study. Sign a consent form. Not all clinical trials study treatments. Even those trials that study treatments, not all are study drugs. When trials look at drugs not all of them are new drugs. Some trials may use a placebo

4. What are the Phases of Clinical Trials

5. Broad Questions to Think About Why do I want to take part in a clinical trial? What are my goals and expectations? Are they realistic? Have I considered the chance of benefits and risks? Have I considered other possible factors, such as travel, time, and money?

6. Questions to Ask the Investigator? Why is this study being done? How is sponsoring this study? What’s likely to happen if I decide to take part or decide not to? How much experience do you have with this treatment? What kind of treatments and tests would I need to have in this study?

7. Questions to Ask the Investigator? Will this study require extra time or travel on my part? Could this study treatment affect my daily life? What side effects might I expect? Are their other short or long term risks? How will we know if this treatment is working? Will I have to be in the hospital? If so, who is going to pay for it?

8. Questions to Ask the Investigator? Will I have costs? Will the treatment be for free? Will my insurance cover any of this? If I am harmed as a result, what treatment will I be entitled? How long is the study going to last? If this treatment works, can I stay on the therapy? Will my information remain confidential? How?

9. Activity: Consent Form Take a minute and look at the consent form provided to you. Think about: What is included? Is it readable? Do you understand the risks and benefits? Does it answer your questions?

10. Questions