PHC 6001 Exam 2 Questions with
Guaranteed Pass Solutions 2025-2026
Updated.
What are the main types of Epidemiological Studies? - Answer experimental, cohort, case-
control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - Answer investigates the role of some agent in the
prevention or treatment of a disease.
What are the two groups in a typical trial? - Answer Treatment group and comparison group
What distinguishes experimental from observational studies? - Answer active manipulation
of the agent by the investigator
what are trials that measure the prevention or treatment? - Answer prevention: preventive
or Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - Answer 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.
What are two ways to approach analysis - Answer 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? - Answer Equipoise is characterized by genuine uncertainty
about the risks and benefits of the test treatment.
what is masking? - Answer the investigator is unaware of the participant's treatment
assignment
Why mask? - Answer reduces biased assessment
rigor of the study improves
, What are different types of experimental studies? - Answer Individual vs Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - Answer 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? - Answer 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.
Phase 2? - Answer a phase 2 trial is conducted on a larger number of diseased individuals to
obtain preliminary information on efficacy and additional information on safety, including side
effects.
Phase 3? - Answer Phase 3 trials also gather information on a drug's indications of use,
recommended doses, and side effects, which are all necessary for administering the drug
appropriately in clinical practice.
After Phase 3? - Answer after? When a phase 3 trial is complete, the drug manufacturer can
request to market the drug for the indication covered by the trial. After approval of the new
drug application, a phase 4 trial and postmarketing surveillance may be conducted to determine
long-term safety and efficacy of the drug. A phase 4 trial may be needed because rare and
slowly developing adverse events may not become evident during the typical 3-year phase 3
trial.
What restricts study population? - Answer eligibility criteria based upon scientific, safety and
practical consideration
What are the factors that influence the sample size to have enough statistical power? - Answer
the anticipated difference between the treatment and comparison groups
the background rate of the outcome
the probability of making statistical errors known as alpha and beta error
What is the process of gaining the agreement from individuals? - Answer informed consent
Guaranteed Pass Solutions 2025-2026
Updated.
What are the main types of Epidemiological Studies? - Answer experimental, cohort, case-
control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - Answer investigates the role of some agent in the
prevention or treatment of a disease.
What are the two groups in a typical trial? - Answer Treatment group and comparison group
What distinguishes experimental from observational studies? - Answer active manipulation
of the agent by the investigator
what are trials that measure the prevention or treatment? - Answer prevention: preventive
or Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - Answer 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.
What are two ways to approach analysis - Answer 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? - Answer Equipoise is characterized by genuine uncertainty
about the risks and benefits of the test treatment.
what is masking? - Answer the investigator is unaware of the participant's treatment
assignment
Why mask? - Answer reduces biased assessment
rigor of the study improves
, What are different types of experimental studies? - Answer Individual vs Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - Answer 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? - Answer 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.
Phase 2? - Answer a phase 2 trial is conducted on a larger number of diseased individuals to
obtain preliminary information on efficacy and additional information on safety, including side
effects.
Phase 3? - Answer Phase 3 trials also gather information on a drug's indications of use,
recommended doses, and side effects, which are all necessary for administering the drug
appropriately in clinical practice.
After Phase 3? - Answer after? When a phase 3 trial is complete, the drug manufacturer can
request to market the drug for the indication covered by the trial. After approval of the new
drug application, a phase 4 trial and postmarketing surveillance may be conducted to determine
long-term safety and efficacy of the drug. A phase 4 trial may be needed because rare and
slowly developing adverse events may not become evident during the typical 3-year phase 3
trial.
What restricts study population? - Answer eligibility criteria based upon scientific, safety and
practical consideration
What are the factors that influence the sample size to have enough statistical power? - Answer
the anticipated difference between the treatment and comparison groups
the background rate of the outcome
the probability of making statistical errors known as alpha and beta error
What is the process of gaining the agreement from individuals? - Answer informed consent
