Deck 7: Experimental Studies

Question 1

Which of the following is characterized by a genuine uncertainty about the risks and benefits of the test treatment?

A) Bias
B) Validity
C) Equipoise
D) Confounding

Answer 1

Equipoise

Question 2

Which of the following, which means that the investigator is unaware of the participant's treatment assignment, reduces the chance of making biased assessment of the outcome and therefore improves the rigor the study?

A) Masking
B) Equipoise
C) Confounding
D) Randomization

Answer 2

Masking

Question 3

Trials that prevent or delay disease progression among diseased individuals are referred to as which type of trials?

A) Parallel trial
B) Therapeutic trial
C) Primary prevention trial
D) Secondary prevention trial

Answer 3

Secondary prevention trial

Question 4

A phase 1 drug trial is conducted to provide preliminary information on drug safety using a relatively small number of normal, healthy volunteers. Which type of drugs are an exception in which trials are conducted in patients who usually have advanced disease?

A) HIV antiviral medications
B) Alzheimer's dementia medications
C) Cancer chemotherapeutic agents
D) Female infertility medications

Question 5

After which phase of the trial is complete, the drug manufacturer can request to market the drug for the indication covered by the trial?

A) Phase 1
B) Phase 2
C) Phase 3
D) Phase 4

Question 6

The ability of a study to demonstrate an association if one indeed exists is referred to as which of the following?

A) Validity
B) Reliability
C) Consistency
D) Statistical power

Question 7

Some researchers believe that performing which of the following, a statistical procedure that pools data from many small trials, is a viable alternative to conducting large trials?

A) Chi-square tests
B) Meta-analysis
C) Logistic regression
D) Paired t-test

Question 8

The active manipulation of the treatment by the investigator is the hallmark that distinguishes experimental from observational studies.

Question 9

Therapeutic trials are commonly called clinical trials because they are conducted in a clinical setting among diseased patients and often use a clinical outcome measure such as recurrence or side effects.

Question 10

Although random assignment methods are simple and easy to follow, they are predictable and thus may lead to situations that allow biased assignment.

Question 11

Which type of trials may involve behavior modifications such as dietary improvements, reducing substance use and antisocial behavior, and physical exercise?

A) Parallel trials
B) Crossover trials
C) Preventive trials
D) Therapeutic trials

Question 12

Which type of trial is commonly called clinical trials because they are conducted in a clinical setting among diseased patients and often use a clinical outcome measure, such as recurrence or side effects?

A) Parallel trials
B) Crossover trials
C) Preventive trials
D) Therapeutic trials

Question 13

If a drug efficacy trial among ovarian cancer patients is of which design, women in the experimental group would first receive the standard treatment and new drug combination and then the standard regimen alone, whereas those in the comparison group would first receive the standard regiment alone and then the standard treatment plus new drug combination?

A) Simple design
B) Factorial design
C) Parallel design
D) Crossover design

Question 14

Which of the following is the bane of an investigator's life because it results in a smaller difference between the treatment and comparison groups than truly exists, and reduces the statistical power of the study?

A) Disobedience
B) Noncompliance
C) Nonadherence
D) Maladjustment

Question 15

Which of the following is a judgment in which the investigator applies "the conclusions of a trial to the broader setting of general medical care and to a more heterogenous set of patients than those studied"?

A) Validity
B) Reliability
C) Consistency
D) Generalizability

Question 16

A shift in which of the following often occurs when a clear benefit or adverse effect is observed for the test treatment in an interim data analysis from the ongoing trial?

A) Bias
B) Validity
C) Equipoise
D) Confounding

Question 17

Which of the following refers to the group of people to whom the study results may be applied or generalized?

A) Index population
B) Reference population
C) Candidate population
D) Catchment population

Question 18

Several practical and ethical problems must be solved when observational studies are conducted.

Question 19

An institutional review board review is particularly important in experimental studies because a state of equipoise must exist for the study to be ethical.

Question 20

In some preventive trials, the alleged causal factor is reduced or removed.