Lecture 7 - Is This Intervention Effective? Flashcards
What is the sequence in modern clinical trials?
- In vitro studies
- Animal in vivo studies
- Human Phase 1 - toxicology and pharmacokinetics
- Human Phase 2 - evidence of efficacy
- Human Phase 3 - RCTs
- Human Phase 4 - post-marketing surveillance
What are the critical appraisal guides?
- Is it valid?
- How large and precise is the effect?
- Can I apply these results to my patient
What are some key characteristics for critical appraisal?
- Ascertainment (comparable groups, treated equally, follow-up complete)
- Measurement (blinded, objective)
What is the best and most valid technique in ensuring allocation concealment?
Central computer randomization
What is the principle in maintaing randomization?
Once a patient is randomized, s/he should be analyzed in the group randomized to (even if they discontinue, never receive treatment, or crossover
What is the exception to the principle in maintaining randomization?
If patient is found on BLIND reassessment to be ineligible based on pre-randomization criteria
What’s the difference between Intention to Treat vs Per Protocol?
- ITT provides a measure of effectiveness of an intervention
- PP analysis proves efficacy measure (ideal world because it only measure pt who are able to completely adhere to full treatment regime)