What is a case series? - ANSW Description of clinical findings/symptoms for several
patients with the same diagnosis, treatment, or outcome.
What is a cross-sectional study? - ANSW Assesses the frequency of disease and risk-
related factors in the present.
What is a case-control study? - ANSW Retrospectively compares a group of people
with a disease to a group without the disease to determine if odds of prior exposure/risk
factor differ.
What is a cohort study? - ANSW Compares a group of people with a given
exposure/risk factor to a group without exposure to determine if the exposure/risk factor
is associated with later development of disease.
What is a twin concordance study? - ANSW Compares the frequency with which both
monozygotic twins vs both dizygotic twins develop the same disease to measure
heritability and influence of environmental factors.
What is an adoption study? - ANSW Compares behavioral traits/genetics in siblings
raised by biological vs adoptive parents to measure heritability and influence of
environmental factors.
What is an ecological study? - ANSW Compares the frequency of disease and risk-
related factors across populations to measure population data (not applicable to
individuals).
What is a clinic therapeutic trial? - ANSW An experimental study involving humans that
compares the benefits of two or more interventions.
What are the criteria for a high-quality clinical trial? - ANSW Randomized, controlled,
and double-blinded
What is a crossover clinical trial? - ANSW Compares the effect of multiple treatments
on a subject
What is the purpose of randomizing the order of treatments in a crossover trial? -
ANSW To avoid bias
What is a washout period in a crossover trial? - ANSW A period between treatments to
eliminate any lingering effects
, What is the advantage of using a crossover trial? - ANSW Subjects serve as their own
controls
What is the intention-to-treat analysis? - ANSW Analyzing all subjects according to
their original assigned treatment
What is the purpose of intention-to-treat analysis? - ANSW To avoid bias from attrition,
crossover, and noncompliance
What is the disadvantage of intention-to-treat analysis? - ANSW May dilute the true
effects of the intervention
What is the as-treated analysis? - ANSW Analyzing subjects according to the
treatment they actually received
What is the disadvantage of as-treated analysis? - ANSW Increases the risk of bias
What is the per-protocol analysis? - ANSW Excluding subjects who did not complete
the originally assigned treatment
What is the disadvantage of per-protocol analysis? - ANSW Increases the risk of bias
What are the five phases of clinical trials? - ANSW Preclinical, Phase 0, Phase 1,
Phase 2, Phase 3, Phase 4
What happens in the preclinical phase of clinical trials? - ANSW Testing the drug in lab
animals and in vitro
What happens in Phase 0 of clinical trials? - ANSW Initial assessment of
pharmacokinetics and pharmacodynamics via microdosing
What is the purpose of Phase 1 of clinical trials? - ANSW Safety assessment and
determining the maximum tolerable dose
What is the purpose of Phase 2 of clinical trials? - ANSW Assessing efficacy and
short-term adverse effects
What is the purpose of Phase 3 of clinical trials? - ANSW Assessing effectiveness
compared to standard of care or placebo
What is the purpose of Phase 4 of clinical trials? - ANSW Assessing long-term and
rare adverse effects
What is off-label drug use? - ANSW Using a drug in a form, population group, or
dosage not approved by the FDA