exam 1 Flashcards
what is pharmacoepideminology
the study of the use and effect of drugs in large numbers of people
pharmacology vs clinical pharmacology
pharmacology study of effects of drugs while clinical pharmacology is the study of effect of drugs in humans
epidemology vs pharmacoepi
epidemology is the study of the distribution and determinants of diseases in populations
pharmcoepi is a subset
pure food and drug act 1906
in response to excessive adulteration and misbranding of food and drug at that time. Fed gov now allowed to remove drug that was adulterated or misbranded
food, drug and cosmetics act
in response to people dying from renal failure. Preclinical toxicity testing required and manufacturers required to gather clinical data about drug
Case report
- report of an event in a single patient
- useful in generating hypotheses
Case series and when useful
collections of patients all of whom have either a single exposure or single outcome
- useful: quantify an ADE and ensure ADE are not happening in population larger than that studied prior to drug marketing
case-control studies
compare cases (w/ outcome) to controls (w/o outcome) to look for differences in
cohort studies
a study that identifies a cohort of subjects and follows them over time to determine outcome
random control/clinical trial
a study where participants are randomly assigned between exposure and control groups
pragmatic clinical trials
A study in which the investigator tests the effectiveness of an intervention under ‘real-world’ conditions
different types of bias
- information bias: interviewer and recall bias
- selecting bias: control doesnt represent the population that produced the cases
what is a confounder
a variable related to both the exposure and the outcome
- variable distributed unequally b/w the groups
why dont RCTs translate to the real world
problems with clinical trials
- expensive
- small
- often drugs are compared against placebo
- exclude elderly, children, pregnant women, patients w/ comorbidities
- not timely
- unethical
pragmatic clinical trials design and setting
designed to improve practice and policy
- take place in settings where everyday care happens, such as community clinics, hospitals and health systems
rct vs pct
- GOALS
- RCT determine causes and effects of therapy
- PCT: improves practice and inform clinical and policy decisions
rct vs pct
- design
- RCT: test intervention against placebo
- PCT: test 2 or more real-world treatments using flexible protocols and local customization
rct vs pct
- participants
- RCT: highly defined and carefully selected
- PCT: more representative b/c less strict criteria
rct vs pct
- measures
- RCT: require data collection outside routine clinical care
- PCT: brief and designed so data can be easily collected in clinical settings
rct vs pct
- results
- RCT: rarely relevant to everyday practice
- PCT: useful in everyday practice, especially clinical decision making
Pragmatic research features
- use EHRs
- randomize treatment alt based on normal health care operations
Comparative effectiveness research
A rigorous evaluation of the impact of different options that are available for treating a given medical condition for a particular set of patients.