Lecture 4 Flashcards
What are 2 things MUST be done in human clinical trials
- Must go through rigorous review by international ethics review board
- Must always done with volunteers
What are the purposes of human clinical trials
Performed to test new drug safety
What are the order of trials
- Preclinical
- Phase I clinical trials
- Phase II clinical trials
- Phase III clinical trial
- After approval
What goes on in preclinical trials
Animal studies before testing on humans
What goes on in phase I clinical trials
- Is the drug safe for humans?
- What is a face dose?
- What are the side effects?
- Test done on a small group of people
What goes on in phase II clinical trials
- Does the drug work for its intended purpose (effectiveness)
- How well does the vaccine work
- Is it safe on a larger group of people
- What is the safest and most effective approach
- Test done of large group of people (100s)
What goes on in phase III clinical trials
- How does the drug compared to other treatments available
- Does the vaccine prevent diseases
- What Are the side effects
- Larger group of people (1000s)
What goes on in after approval
- Manufacturer submits applications to health Canada for reviews
- Ongoing assessment of long-term use, benefits, and risks
What are the order of reviews and approval of vaccines
- Scientific Review
- Approval
- Distribution
- Vaccination
- Mobitering
What happens during scientific review of vaccines
Health Canada experts conduct through and independent review of vaccines
What happens during approval of vaccines
Health Canada approves vaccine IF: It is safe, works, meets manufacturing standers, and benefits outweigh risks
What happens during distribution of vaccines
Government coordinates the purchase, logistics, and distribution of vaccines across Canada
What happens during vacination of vaccines
All Canadians have access to vaccines
What happens during monitoring of vaccines
Continuous monitoring takes place to confirm safety of vaccine and that the benefits outweigh the risks
What is evidence-based medicine
Applying scientific evidence to clinical decisions