PHC 6001 EXAM 2 2025 QUESTIONS AND
ANSWERS
What are the main types of Epidemiological Studies? - ANS experimental, cohort, case-
control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - ANS investigates the role of some agent in the prevention
or treatment of a disease.
What are the two groups in a typical trial? - ANS Treatment group and comparison group
What distinguishes experimental from observational studies? - ANS active manipulation of
the agent by the investigator
what are trials that measure the prevention or treatment? - ANS prevention: preventive or
Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - ANS The purpose of the run-in period is to ascertain which
potential participants are able to comply with the study regimen. During this period,
participants are placed on the test or comparison treatment to assess their tolerance and
acceptance and to obtain information on compliance. Following the run-in period, only
compliant individuals are enrolled in the trial.
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, What are two ways to approach analysis - ANS intent-to-treat (treatment assignment)
analysis- An intent-to-treat analysis gives information on the effectiveness of a treatment under
everyday practice conditions.
Efficacy analysis- determines the treatment effects under ideal conditions, such as when
participants take the full treatment exactly as directed.
What is state of equipoise? - ANS Equipoise is characterized by genuine uncertainty about
the risks and benefits of the test treatment.
what is masking? - ANS the investigator is unaware of the participant's treatment assignment
Why mask? - ANS reduces biased assessment
rigor of the study improves
What are different types of experimental studies? - ANS Individual vs Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - ANS Trials that prevent or delay the
onset of disease among healthy individuals are called primary prevention trials, and trials that
prevent or delay progression among diseased individuals are termed secondary prevention
trials.
What happens in phase1? - ANS A phase 1 drug trial is conducted to provide preliminary
information on drug safety using a relatively small number of normal, healthy volunteers.
This trial provides metabolic and pharmacologic profiles of the drug, including determination of
the maximally tolerated dose.
2 Copyright ©BRIGHSTARS ALL RIGHTS RESERVED 2025
ANSWERS
What are the main types of Epidemiological Studies? - ANS experimental, cohort, case-
control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - ANS investigates the role of some agent in the prevention
or treatment of a disease.
What are the two groups in a typical trial? - ANS Treatment group and comparison group
What distinguishes experimental from observational studies? - ANS active manipulation of
the agent by the investigator
what are trials that measure the prevention or treatment? - ANS prevention: preventive or
Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - ANS The purpose of the run-in period is to ascertain which
potential participants are able to comply with the study regimen. During this period,
participants are placed on the test or comparison treatment to assess their tolerance and
acceptance and to obtain information on compliance. Following the run-in period, only
compliant individuals are enrolled in the trial.
1 Copyright ©BRIGHSTARS ALL RIGHTS RESERVED 2025
, What are two ways to approach analysis - ANS intent-to-treat (treatment assignment)
analysis- An intent-to-treat analysis gives information on the effectiveness of a treatment under
everyday practice conditions.
Efficacy analysis- determines the treatment effects under ideal conditions, such as when
participants take the full treatment exactly as directed.
What is state of equipoise? - ANS Equipoise is characterized by genuine uncertainty about
the risks and benefits of the test treatment.
what is masking? - ANS the investigator is unaware of the participant's treatment assignment
Why mask? - ANS reduces biased assessment
rigor of the study improves
What are different types of experimental studies? - ANS Individual vs Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - ANS Trials that prevent or delay the
onset of disease among healthy individuals are called primary prevention trials, and trials that
prevent or delay progression among diseased individuals are termed secondary prevention
trials.
What happens in phase1? - ANS A phase 1 drug trial is conducted to provide preliminary
information on drug safety using a relatively small number of normal, healthy volunteers.
This trial provides metabolic and pharmacologic profiles of the drug, including determination of
the maximally tolerated dose.
2 Copyright ©BRIGHSTARS ALL RIGHTS RESERVED 2025
