Stats from passmed Flashcards
5 phases of clinical trial
0 = exploratory studies
1 = safety assessment = healthy volunteers
2 = assess efficacy = small no. pt affected by disease
3 = assess effectiveness = 100-1000s = rct = compare new and established
4 = post marketing surveillance = effective and se
confidence interval definition
- range of values within which the true effect of intervention is likely to lie
- e.g. 95% = CI should contain the true effect of the intervention 95% of the time
4 phases of drug development
1 = small studies on healthy = assess dynamic and kinetic
2 = small on pt = efficacy and adverse
3 = larger = efficacy and effects = comapres
4 = post marketing surveillance
incidence is
no. new cases per population in given time period
prevalence is
total number of cases per population at a particular point in time
Odds ratio
a/c : b/d
sensitivity
true positive / true positive + false negative
proportion with condition and +ve result
specificity
TN/TN + FP
proportion without the condition with a -ve result
PPV
TP/TP+FP
chance pt has condition if test is positive
NPV
TN/TN+FN
chance doesnt have condition if test -ve
RCT
random allocation to intervention or control
cohort
observational and prospective
- selected according to exposure and followed up to see how many develop outcome
case control
observational and retrospective
- pt with condition identified and matched with controls
- data collected on past exposure
- cheap and good for rare
- confoudning