Drug Development Process

Name:

Date:

📚 Part 1: Drug Development Knowledge

1. Which phase of clinical trials involves the largest number of participants?

Phase I

Phase II

Phase III

Preclinical testing

2. Select all sources from which medicines can be developed:

Plants and fungi

Laboratory synthesis

Animal compounds

Microorganisms

3. What is a placebo?

An inactive substance that looks like the real medicine

A very strong dose of medicine

A natural plant extract

The first version of a new drug

4. Put the stages of drug development in the correct order by numbering 1-5:

____ Phase III clinical trials

____ Drug discovery and design

____ Regulatory approval

____ Preclinical testing

____ Phase I clinical trials

✏️ Part 2: Understanding and Application

5. Explain why clinical trials use control groups and placebos:

6. Describe one ethical consideration that must be addressed during clinical trials:

7. A new painkiller takes 12 years and costs £800 million to develop. Explain why drug development is so expensive and time-consuming:

🎭 Part 3: Drug Development Simulation Activity

8. You will be assigned one of these roles for a group discussion. Read your role and prepare your viewpoint:

Scenario: A new cancer treatment shows promise but has serious side effects in 15% of patients.

Scientist: Focus on the scientific evidence and potential benefits

Clinical Trial Coordinator: Consider patient safety and trial procedures

Ethics Officer: Weigh risks versus benefits and patient rights

Patient Advocate: Represent patient needs and concerns

Regulator: Decide if the drug should be approved for public use

9. From your assigned role's perspective, should this drug continue to Phase III trials? Explain your reasoning:

10. After the group discussion, describe one viewpoint that differed from yours and why it was important to consider:

Drug Development Process

Drug Development Process

📚 Part 1: Drug Development Knowledge

✏️ Part 2: Understanding and Application

🎭 Part 3: Drug Development Simulation Activity

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