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Chapter 7

Chapter 7. Data Ethics. Thought Question 1.

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Chapter 7

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  1. Chapter 7 Data Ethics Chapter 7

  2. Thought Question 1 Many new treatments for rapidly lethal diseases offer very little or no benefit to patients. Thus, clinical trials to study the effectiveness of these treatments require large numbers of participants to determine if there is any benefit at all. Should patients volunteering for such trials (as a last resort, or to “advance science”) be told of their low chance of receiving benefits? What if the toxicity of the treatment may be harmful? Chapter 7

  3. Experiments:Ethical Requirements • Institutional review board • to protect subjects from possible harm • Informed consent • Confidentiality Chapter 7

  4. Confidentiality and Anonymity • Confidential answer • respondent is known, but the information is a secret • Anonymous answer • the respondent is not known, or cannot be linked to his/her response Chapter 7

  5. Clinical Trials • Experiments that study the effectiveness of medical treatments on actual patients • Need comparative experiments to see true effects of new treatments • Balance future benefits against present risks • “Interests of the subject must always prevail over the interests of science and society” Chapter 7

  6. Clinical TrialsControversies • Belief that the treatment is effective to justify exposing subjects to it; doubt that the treatment is effective to justify withholding it from other subjects • When is the treatment effective enough to stop the study and assign the treatment to the placebo or control groups also? • When is the treatment harmful enough to stop the study and discontinue use of the treatment? • Who can give consent? Chapter 7

  7. Case Study Drug Company Pulls Product • Vioxx is a prescription anti-inflammatory drug that was approved by the FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, acute pain, menstrual symptoms, and rheumatoid arthritis • Ongoing long-term study of Vioxx was being conducted in patients at risk for developing recurrent colon polyps • study showed an increased risk of heart attack and stroke in patients on Vioxx compared to placebo, particularly those who had been taking the drug for longer than 18 months • Data Safety Monitoring Board recommended that the study be stopped early for safety reasons • Merck & Co. voluntarily withdrew Vioxx from U.S. market in Sept. 2004 Release from Food and Drug Administration, September 30, 2004 Chapter 7

  8. Key Concepts • Basic data ethics • Confidential vs. Anonymous • Clinical trials Chapter 7

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