Lesson 3: Testing Medicines Clinical Trial Challenge: How are medicines tested during a clinical trial White space White space Have you ever had a migraine or a bad headache? What did you do? Introduction: Scenario Vocabulary: clinical trial. control, placebo, sample size, Simulate, Simulation, tradeoff Materials: √ Procedure: √ Data: Results of Treatment Data Table Results of a clinical Trial - Transparency 3.1 Analysis of a clinical trial - Student 3.1 Analysis: AQ 1 AQ 2, AQ3, AQ4,

Imagine the following: You work for a company that develops medicines. You have developed a medication for severe headaches and have tested it on rats and mice to see if it has any negative effects. The tests on animals showed no harmful effects, even at much higher doses than you plan to use on humans. Now it is time to test the medicine on human volunteers in a clinical trial. 1 What could happen to these volunteers after they take the medicine? How would you test the medicine to be sure it is safe and improves the health of headache patients? (answer in white space)

2 You will participate in a simulation of the trials that are used to determine whether medicines are effective and safe for people. A simulation is an experience that is meant to mimic, or be like, another experience.

Safety Note Never taste materials or eat or drink in science class unless specifically told to do so by your teacher. Be sure that your work area is clean and free of any materials not needed for this activity. If you are allergic to lemons or other citrus fruits, juice drinks, or sugar, or if you have any other health issue, such as diabetes, that limits what you can eat, tell me teacher and do not taste the drink samples in this activity. Keep track of all cups. Do not dip small cups into the large cups it will contaminate the cups. Do a simulated trial so we don’t test on students.

Before you can start the Lab Activity your entire group must do all of the following: 1. Complete the lesson page set up Complete the vocabulary Draw the data table Materials Manager collects all safety cards Materials manager must know how many materials they are responsible for. All students record data in notebook, recorder records on separate sheet to turn in.

The taste of the yellow lemon drink represents the headache. 2 The taste of the yellow lemon drink represents the headache. 1. A perception that the orange lemon drink tastes better than the yellow lemon drink represents feeling better. 2. A perception that the orange lemon drink tastes the same as the yellow lemon drink represents no change in the headache. 3. A perception that the orange lemon drink tastes worse than the yellow lemon drink represents an improvement in the headache but with side effects.

Not all drinks were the same! 4 Results Based on these results does the “medicine” appear to have worked? Not all drinks were the same! Yellow and one orange liquid was the same. The orange liquid that was the same as the yellow is called a placebo. (Control Group) One of the orange liquids had twice as much sugar. This was the one with the medicine (sugar)

Results Why was it important to have a group that did not receive the medicine? This group allows for comparison, and helps investigators evaluate if changes are due to the medicine or to some other factor. Did Dr. Goldberger’s experiment on prisoners have a control? No. How could he have set up a control? He could have included prisoners who continued to receive a healthy diet, but underwent all of the other conditions of those who were on the restricted diet.

Not all drinks were the same! 4 Results Based on these results does the “medicine” appear to have worked? Not all drinks were the same! Yellow and one orange liquid was the same. The orange liquid that was the same as the yellow is called a placebo. (Control Group) One of the orange liquids had twice as much sugar. This was the one with the medicine (sugar)

Clinical Trial In a clinical trial that tests medicine, one group gets a pill or liquid that contains an inactive ingredient, while a different group gets a pill or liquid with the medicine that is being tested. In this simulation, the orange drink simulated taking a pill or liquid. The sugar represented the active ingredient.

Was there a control in the experiment we just did? What is a Placebo? a control that simulates a medicine but doesn’t have the active ingredient Was there a control in the experiment we just did? The orange drink without the extra sugar In a real test of a medicine, one group receives a pill or liquid containing inactive ingredients, while another group receives a pill or liquid containing the medicine. In this model, the red food coloring was used to represent the idea of taking a pill or liquid, while the sugar represented the active ingredient in the medicine. These controls are part of one standard method for testing medicines, and that a pill or Treatment used as a control in this way is called a placebo.

Analysis Questions 1. What evidence do you have that the medicine (pink with sugar) does or does not work to improve headaches? In our class, __ people received the pink lemon drink with sugar, which represented the medicine. Of those __ people, __ thought it tasted better than the yellow lemon drink. One person thought it tasted the same and one thought it tasted worse. This means that __ out of __ people felt better after taking the medicine (although one suffered side effects). This shows that the medicine works to improve headaches. 2. a. What is a placebo? A placebo is a pill or liquid that looks like one containing medication, but it contains only inactive ingredients. 2b. Why is a placebo group included in clinical trials? The placebo group provides a control to be sure that it is the medicine and not some other variable causing the improvement.

3. In this activity, if a person finds that the drink tastes worse, the headache is gone, but there are side effects. a. Assume that the side effects are mild, such as a slight stomachache. Explain why this medicine should or should not be sold to people suffering from a headache. Are there any trade-offs involved in your decision? It should be sold. Place a warning on the label. Many people would be willing to trade off their severe headache for a slight stomachache. 4. In this activity, if a person finds that the medicine tastes better or worse, the headache is gone. Review the results of this simulation. Think about whether the medicine works and how often side effects occur. What would you conclude about the safety and effectiveness of this medicine for treating headaches? Support your conclusion with evidence.