10. EBM vs alternative medicine Flashcards
Pharm R&D
Basic research- synthesis examination and screening of 10,000-30,000 substances (3 years)
Development 7 years - preclinical tests (animal) 10-20 substance, phase 1 5-10, phase 2 2-5, phase 3 2 substances
Registration and introduction of drug 2 years, product surveillance. Phase IV of development
Four tests for a new drug
Efficacy
Safety
Convenience
Cost
Efficacy
Best level of evidence of efficacy
Expected comparator
Clinical endpoints
Safety
Adverse event profile
Safety advantages/disadvantages
Convenience
Formulation
Route of admission
Taste
Dose frequency
Cost
number of patients
cost implications for patient
cost implications for organisation
cost effectiveness analysis
Evidence based medicine definition
The use of mathematical estimates of the risk of benefit and harm, derived from high quality research on population samples, to inform clinical decision making in the diagnosis, investigation or management of individual patients
Principle of EBM
treat where there is evidence of benefit and do not treat where there is evidence of no benefit or harm
Levels of evidence
- animal and lab studies
- case report or case series, narrative reviews, expert opinions, editorials
- Case control studies: retrospective: subjects have the outcome of interest and you are looking for risk factors
- Cohort studies. These are perspective: the cohort has been exposed to a risk and you observe for outcome of interest.
- Randomised controlled trials: prospective, tests treatment
- Meta-analysis systematic reviews
- Clinical practice guidelines
Primary studies vs secondary
Primary are case control studies, cohort studies and randomised controlled trials
Secondary are meta-analysis, systematic review and clinical practice guidelines
PICO-M
patient, problem intervention comparison, control outcome, effects methodology
Clinical trial interpretation
are study results clinically important?
are study results relevant to practice?
are study methods valid?
Validity of methods
Randomised assignment of patients?
analysis in groups allocated?
Follow up long enough?
ISIS-2
Placebo vs streptokinase vs aspirin vs aspirin and sk
risk most reduced in using both aspirin and sk
Clinical importance
hard endpoints? size of treatment effect? statistical significance? adequate power conclusions based on questions posed and results obtained?
