Download Activity #4

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.