PHC 6001 Exam 2 EXAM 2025 COMPLETE EXAM
QUESTIONS AND ACCURATE ANSWERS |ALREADY
PASSED!!
What are the main types of Epidemiological Studies? - (answers)experimental,
cohort, case-control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - (answers)investigates the role of some agent in
the prevention or treatment of a disease.
What are the two groups in a typical trial? - (answers)Treatment group and
comparison group
What distinguishes experimental from observational studies? - (answers)active
manipulation of the agent by the investigator
what are trials that measure the prevention or treatment? - (answers)prevention:
preventive or Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - (answers)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 - (answers)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? - (answers)Equipoise is characterized by genuine
uncertainty about the risks and benefits of the test treatment.
what is masking? - (answers)the investigator is unaware of the participant's
treatment assignment
Why mask? - (answers)reduces biased assessment
rigor of the study improves
What are different types of experimental studies? - (answers)Individual vs
Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - (answers)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? - (answers)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? - (answers)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? - (answers)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? - (answers)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? - (answers)eligibility criteria based upon
scientific, safety and practical consideration
QUESTIONS AND ACCURATE ANSWERS |ALREADY
PASSED!!
What are the main types of Epidemiological Studies? - (answers)experimental,
cohort, case-control, case-crossover, ecological, and agent-based modeling
What is an experimental study? - (answers)investigates the role of some agent in
the prevention or treatment of a disease.
What are the two groups in a typical trial? - (answers)Treatment group and
comparison group
What distinguishes experimental from observational studies? - (answers)active
manipulation of the agent by the investigator
what are trials that measure the prevention or treatment? - (answers)prevention:
preventive or Prophylactic trial
Treatment: therapeutic or clinical trial
What is a run-in period? - (answers)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 - (answers)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? - (answers)Equipoise is characterized by genuine
uncertainty about the risks and benefits of the test treatment.
what is masking? - (answers)the investigator is unaware of the participant's
treatment assignment
Why mask? - (answers)reduces biased assessment
rigor of the study improves
What are different types of experimental studies? - (answers)Individual vs
Community
Preventive vs Therapeutic
Parallel vs Crossover Trials
Simple vs Factorial Design
What are primary and secondary prevention trials? - (answers)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? - (answers)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? - (answers)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? - (answers)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? - (answers)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? - (answers)eligibility criteria based upon
scientific, safety and practical consideration
