1. Clinical Trials “What you need to know” April 2, 2008

2. Questions to Ask: Who were the subjects, researchers, and sponsors? Who were the subjects, researchers, and sponsors? How was the study done? How was the study done? How many people in the study? How many people in the study? Where were they studied? Where were they studied? What was studied? What was studied? When and for how long was the study done? When and for how long was the study done?

3. The types of clinical trials/studies Meta-analysis or systematic review Meta-analysis or systematic review Single randomized controlled trial (RCT) Single randomized controlled trial (RCT) Cohort study Cohort study Case-control study Case-control study Cross-sectional studies Cross-sectional studies Small case studies Small case studies Expert opinion Expert opinion Single case or testimonials Single case or testimonials

4. Interpreting the statistical results Some useful references: “Users guide to evidence-based practice” www.cche.net/usersguides/main.asp “How to read a scientific paper: Statistics for the non- statician” www.bmj.com/cgi/content/full/315/7124/364 “Guidelines for reporting statistics in biomedical research: 20 reporting errors you should not make” www.medizin.uni- koeln.de/klinen/augenklinik/images/StatGuideLine.pdf www.medizin.uni- koeln.de/klinen/augenklinik/images/StatGuideLine.pdf

5. How patients interpret clinical trials Risk is imminent Risk is imminent Association equal causation Association equal causation If it’s in print, it must be true If it’s in print, it must be true Technology is terrific Technology is terrific Drugs are bad Drugs are bad Natural is healthy Natural is healthy Treatments are cures Treatments are cures

6. Questions that participants in a clinical trial should ask What is a clinical trial? What is a clinical trial? Why participate in a clinical trial? Why participate in a clinical trial? Who sponsors clinical trials? Who sponsors clinical trials? What is protocol? What is protocol? What is the placebo that will be used? What is the placebo that will be used? Who will be participating in the trial? Who will be participating in the trial? What happens during a clinical trial? What happens during a clinical trial? Will I have to sign an informed consent? Will I have to sign an informed consent? Are there any side affects or adverse reactions? Are there any side affects or adverse reactions? How will my safety be protected? How will my safety be protected?