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
What are Cochrane reviews
A database of systematic reviews and meta-analysis which summarize and interpret the results of medical research
What is the pyramid of evidence based medicine
- In Silico research
- In vitro research
- Animal model research
- Case-control surrey studies
- Cohort survey studies
- Randomized controlled trials
- Clinically appraised papers
- Clinically appraised topics
- Systematic reviews
What are the outcomes of evidence based medicine
Patient values, clinical data and research evidence are taken into considerations
Optimal decisions are the outcomes
What are the 4 new dimensions in medical and healthcare practice
- Evolutionary medicine
- Integrative medicine
- Collective medicine - eco health medicine and one health/one world/one medicine
- Enhancement medicine
What is evolutionary medicine
AKA Darwinian medicine
Application of modern evolutionary history to understand health and disease
Replaces previous view of body as machine to biological view of body shaped by evolutionary process
What are examples of evolutionary medicine
Is the modern diet unhealthy? Should we try to mimic early diets
We get very little exercise in modern society … is this a signal were injured and need to flow down metabolism to initiate inflammatory response
We all have fight or flight responses but if it’s always “on” is there really any follow through
What is integrative medicine
Treats the whole person, not just the disease symptoms
Healing-oriented medicine that takes account of the whole person, including aspects of their lifestyle
Makes use of all appropriate therapies
What is collective medicine
One health’s mission: promote, improve and defend the health and wellbeing of all species by enhancing cooperation and coloration between physicians, veterinarians and other scientific health professionals
Concept - speaks to interconnectedness of animal, human, and environmental health
Approach - working together across disciplines with complex health issues that arise in the intersection of human, animal and environmental health
Examples of enhancement medicine
- Botox
- Viagra and others
- Anabolic steroids
- Liposuction
- Fertility drugs
- Erythropoietin
- Laser vision enhancement
