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Transcript
Activity #4 Testing Medicines Scientifically Key Words • Informed Consent – a form volunteers sign that states that they have been told about the risks and that they agree to participate in the trial. What the Center for Drug Evaluation and Research (CDER) requires to approve a new drug: 1. What happened during the clinical tests. 2. How the drug is made. 3. Results of the animal studies. 4. How the drug behaves in the body. 5. How the drug is manufactured, processed, and packaged. Summary • The placebo effect complicates research on products for human use, such as medicines. • Clinical trials require informed consent of the participants. • Good scientific design requires careful attention to controls.
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