Deck 6: Clinical Therapeutic Trials

Question 1

What is the key limitation of crossover study designs?

A) Researchers using this design have to ensure there has been an appropriate waiting time before the second treatment can be implemented.
B) Each group has to be analyzed by group and not by the individual subjects themselves.
C) Sometimes the two treatments can interfere with each other or have negative effects for the participants.
D) If there is no difference between the study groups, you do not know whether that finding is true or if it could be based on other factors like measurement error.

Answer 1

Researchers using this design have to ensure there has been an appropriate waiting time before the second treatment can be implemented.

Question 2

Which is NOT true about adverse effects questions from a clinical trial?

A) Adverse effects questions are one of the types of questions that can be asked as part of a clinical trial.
B) Side effects should be minimized by planning for adverse events.
C) Side effects questions document adverse events encountered during the course of a trial.
D) The evidence from side effects is often inconclusive.

Answer 2

Side effects should be minimized by planning for adverse events.

Question 3

Which is a disadvantage of using an active comparator arm?

A) There are ethical concerns about denying treatment to some participants.
B) Active comparator arms are less useful than no intervention arms.
C) Use of comparators cannot establish how effective a treatment is over no treatment at all.
D) Active comparator arms are rare because they are not the best way to study a new treatment or therapy.

Answer 3

Use of comparators cannot establish how effective a treatment is over no treatment at all.

Question 4

Which is NOT a kind of randomization?

A) Simple randomization
B) Clinical trial randomization
C) Block randomization
D) Stratified randomization

Question 5

What are the clinical trials that are efficacy studies and typically involve hundreds of patients?

A) Phase I
B) Phase II
C) Phase III
D) Phase IV

Question 6

Which is NOT true of the number needed to treat calculation?

A) Number needed to treat is the number of people needed to be treat so that one person experiences a benefit.
B) Assessing events allows you to assess whether implementation of the treatment will have real-world impact.
C) Assessing events allows you to assess whether implementation of the treatment is financially worthwhile.
D) Number needed to treat is a guarantee that the treatment will be as effective as the number to treat suggests.

Question 7

Which is NOT true of primary questions?

A) They should include references to the outcome measure of interest.
B) They usually focus on patient-based, patient-oriented outcomes.
C) They focus on the lower levels of disability continuums.
D) They focus on those questions that involve quality of life.

Question 8

Which is NOT true of a secondary question?

A) It is one group of five types of questions that can be asked as part of a clinical trial.
B) It is not the reason the research was conducted.
C) It focuses on assessing different dependent measures from the primary questions.
D) It can focus on subgroups within the study.

Question 9

What is a factor in clinical trials? Select all that apply.

A) They have a very specific and intended study population.
B) They are different from experimental research because the studies are done in clinical settings.
C) They are clinically focused.
D) They have better external validity.

Question 10

Which is true about adverse effects questions from a clinical trial? Select all that apply.

A) Side effects should be minimized by planning for adverse events.
B) Adverse effects is one of the types of questions that can be asked as part of a clinical trial.
C) Side effects questions document adverse events encountered during the course of a trial.
D) The evidence from side effects is often inconclusive.

Question 11

What is an example of a clinical trial arm commonly found in clinical trials? Select all that apply.

A) Experimental arm
B) Active comparator arm
C) Placebo arm
D) No control arm

Question 12

What is an advantage of an active comparator arm? Select all that apply.

A) There are no ethical concerns about denying treatment to some participants.
B) Active comparator arms are very useful to no intervention arms.
C) When a well-established treatment is in common use, including it in the study is the best way to test a new treatment.
D) Use of comparators can establish how effective a treatment is over no treatment at all.

Question 13

What is true of using the double blind process in a clinical trial? Select all that apply.

A) Both the participants receiving the treatment and the researchers do not know whether the participants are in the control group or treatment group.
B) Double-blind studies attempt to eliminate observer and subject bias.
C) With double-blind process, every participant is theoretically treated the same way.
D) Because the double-blind method is the gold standard, most published exercise science studies use this process.

Question 14

What is the disadvantage to historical control designs? Select all that apply.

A) Historical control designs cannot establish cause and effect.
B) In historical control designs, treatments are limited to only those treatments that will wash out over time.
C) Historical control designs do not assign participants to groups by random assignment.
D) With historical control designs, because the control and treatment groups are not studied at the same time, it is difficult to know whether the two groups are different because of the intervention or the differences in time.

Question 15

What is the advantage of a factorial design? Select all that apply.

A) It allows the combination of effects to be assessed.
B) It allows multiple treatments to be assessed simultaneously.
C) It allows the interaction of treatments to be assessed.
D) It allows the effect of each treatment to be assessed separately.

Question 16

What is a challenge to the equivalency design? Select all that apply.

A) The shortcoming of the equivalency design is that participants must be receiving an existing treatment that is believed to be or has been shown to be effective.
B) The goal of equivalency studies is to prove that differences between the treatments does not exist, and this is impossible.
C) Random error can hide a difference between the two treatments.
D) In equivalency studies, it is difficult to determine how much difference between the arms will be considered equal.

Question 17

Which are true about the true experimental design of a clinical trial? Select all that apply.

A) Study groups are referred to as study arms.
B) Clinical trial participants are systematically allocated to either a treatment or standard care group.
C) Clinical trials tend to follow patients for an extended period of time.
D) Clinical trials can have subgroups of the treatment arm.

Question 18

Effectiveness has a negative relationship with internal validity.

Question 19

Secondary questions are the type of questions that are often considered substudies within the main study.

Question 20

The key limitation of the factorial study design is that each group has to be analyzed by group and not by the individual subjects themselves.

Question 21

Effectiveness is the clinical term for internal validity.

Question 22

Because clinical trials focus on studying treatments related to disease states, primary questions focus on patient-based, patient-oriented outcomes.

Question 23

When a study uses no blinding or single blinding, the critical consumer should view this research as having less internal validity than a double-blind study.

Question 24

Ancillary questions are addressed by the no intervention arm of the trial.

Question 25

The placebo arm is the clinical trial arm in which the participants receive a fake treatment or therapy that does not include the key components necessary to make the treatment effective.

Question 26

Use of placebos and shams allows you to establish how much of a treatment's effectiveness is caused by simply receiving treatment.

Question 27

A disadvantage of simple randomization is that it can create bias.

Question 28

One of the disadvantages of using stratified randomization is with randomizing individuals based on a specific purpose into groups so that other related factors may also be stratified.

Question 29

The advantage of using the group allocation design is that the treatment only has to be administered once.

Question 30

Population selection is critical to the internal validity of the study.

Question 31

Intent-to-treat is when a researcher analyzes only those participants who completed the study or only those who complied with the treatment protocol.

Question 32

Control event rate is the rate in which events occur in the no-treatment arm of the study.

Question 33

The study design where there is a treatment group and a control group composed of participants who were observed at one time by the researchers or for whom data are available through a database is called ________________________.

Question 34

The key limitation of this study design is that sometimes the two treatments can interfere with each other or have negative effects for the participants. This study design is called ________________________.

Question 35

The study where every participant receives all treatments, and the design is very powerful for testing hypotheses, is called _____________________________________.

Question 36

The kinds of questions that address the origins, evolutions, and interrelationships of a disease are called ________________________.

Question 37

The kind of study design that is considered a true experimental design is called a _________________________.

Question 38

The clinical trial arm in which the participants receive the standard clinically effective treatment is called the ________________________.

Question 39

The term that refers to the process of randomly assigning participants to study groups as they enroll is called ________________________.

Question 40

Studies in which participants are not randomly assigned to a control group or experimental group is called ________________________.