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Clinical Trials “What you need to know”

Clinical Trials “What you need to know”. April 2, 2008. Questions to Ask:. Who were the subjects, researchers, and sponsors? How was the study done? How many people in the study? Where were they studied? What was studied? When and for how long was the study done?.

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Clinical Trials “What you need to know”

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

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

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

  4. Interpreting the statistical resultsSome 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

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

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

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