Clinical Trial Design And Implementation Part 2 Flashcards
In a two group parallel design trial neither the investigator nor the subject is aware of whether the group is the treatment drug or a placebo. This is an example of:
a) Single blinding
b) Double blinding
c) Open label
d) None of the above.
b) Double blinding
In an open label trial:
a) The investigator knows whether the treatment is placebo or treatment
b) Both the investigator and the subject know that the treatment drug is being administered.
c) Neither the investigator not the subject knows whether drug or placebo is being administered
d) The investigator knows that the drug is being administered but the subject does not
b) Both the investigator and the subject know that the treatment drug is being administered.
In a single blind trial:
a) Both the investigator and the subject know that the treatment drug is being administered.
b) Neither the investigator nor the subject knows whether drug or placebo is being administered
c) The investigator knows that the drug is being administered but the subject does not
d) The subject knows that the drug is being administered but the investigator does not
c) The investigator knows that the drug is being administered but the subject does not
A placebo control design is justified when:
a) High placebo response is expected
b) Treatment drug is anticipated to have fluctuating outcomes
c) There is mixed data on the effectiveness of the current standard treatment
d) All of the above.
d) All of the above.
a) High placebo response is expected
b) Treatment drug is anticipated to have fluctuating outcomes
c) There is mixed data on the effectiveness of the current standard
A placebo design in a clinical trial is contraindicated when:
a) Placebo may cause serious harm to the subject
b) When a good comparator drug exists for the trial
c) Where a high rate of morbidity exists for the patients with the disease
d) All of the above.
d) All of the above.
a) Placebo may cause serious harm to the subject
b) When a good comparator drug exists for the trial
c) Where a high rate of morbidity exists for the patients with the disease
Disadvantages of a crossover design include:
a) A carryover effect from one treatment to the other
b) Often not possible for acute disease
c) Cannot be used when the initial treatment has long term or permanent effect (e.g. vaccine trials)
d) All of the above.
d) All of the above.
a) A carryover effect from one treatment to the other
b) Often not possible for acute disease
c) Cannot be used when the initial treatment has long term or permanent
In a matched pair design:
a) For every subject assigned to treatment group A, a matched subject on given characteristics is assigned to treatment group B
b) Intergroup variability is reduced thus lowering the influence of confounding factors
c) May be difficult to implement relative to unmatched parallel group design
d) All of the above.
d) All of the above.
a) For every subject assigned to treatment group A, a matched subject on given characteristics is assigned to treatment group B
b) Intergroup variability is reduced thus lowering the influence of confounding factors
c) May be difficult to implement relative to unmatched parallel group design
In a double blinded placebo control design the reasons for the blinding of the investigator include:
a) Prevent the investigator from reviewing the treatment group more strenuously
b) Prevent the investigator from not recording or reporting serious adverse events in the treatment group
c) Prevent the investigator from making protocol changes which favor the treatment group
d) All of the above.
d) All of the above.
a) Prevent the investigator from reviewing the treatment group more strenuously
b) Prevent the investigator from not recording or reporting serious adverse events in the treatment group
c) Prevent the investigator from making protocol changes which favor the treatment group
Blinding is not advised in the evaluation of a significant risk device in a clinical trial because:
a) Installation of sham device would be unacceptable.
b) The choice between surgery and no surgery for the two groups may mask the real risks of the device to the subject
c) Both a and b
d) Neither a nor b
c) Both a and b
Crossover studies are particularly favored in:
a) Where the placebo group shows large variations
b) In phase one bioequivalence trials
c) Where long acting drugs are involved
d) When a short treatment time is desired for the clinical trial.
b) In phase one bioequivalence trials
Dose escalation is most likely to be used in:
a) Phase 1 trials
b) Phase 2 trials
c) Phase 3 trials
d) Phase 4 trials
a) Phase 1 trials
The goals of a phase 4 trial include:
a) Detection of rare side effects
b) Detection of side effects associated with chronic use of the drug
c) Desensitization and loss of effect of the drug upon continued treatment
d) All of the above.
d) All of the above.
a) Detection of rare side effects
b) Detection of side effects associated with chronic use of the drug
c) Desensitization and loss of effect of the drug upon continued treatment
An important rare side effect is observed for a drug in phase 4 trial. The likely outcome would be:
a) The sponsor ignores the effect because it is rare
b) The sponsor decides not to report it to the FDA
c) The sponsor reports it to the FDA which then imposes a black box warning on the product label.
d) The sponsor reports it to the FDA which resolves not to act on the information.
c) The sponsor reports it to the FDA which then imposes a black box warning on the product label.
The advantages of a disease registry over a specific drug registry in a phase 4 trial is:
a) It provides insights into comparative side effects
b) It provides assessments of cost effectiveness of the different drugs
c) It may allow for comparative assessments of efficacy in the long run
d) All of the above.
d) All of the above.
a) It provides insights into comparative side effects
b) It provides assessments of cost effectiveness of the different drugs
c) It may allow for comparative assessments of efficacy in the long run
The trial which would most influence FDA approval and the final product label for a drug is:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
c) Phase 3
The placebo effect in experimental studies is:
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
An example of demand characteristics in an experimental study is:
a) An effect caused in a treatment group because of the special attention paid to it by
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.
d) An effect, caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
An example of a halo effect in a psychosocial study is:
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait
The Hawthorne effect is:
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
Investigator bias in an experimental study is:
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trial where the perception of one trait is influenced by the perception of another trait.
d) An effect ,caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
The John Henry effect in an experimental study is:
a) An effect caused in a treatment group because of the special attention paid to it by the investigator
b) The participants form an interpretation of the experiment’s purpose and modify their behavior accordingly
c) Occurs in cognitive trials where the perception of one trait is influenced by the perception of another trait.
d) An effect, caused by psychological influence, experienced by the patient when they are unaware that they are not being administered the medication for the clinical trial
e) The investigator’s paradigm in experimental design and analysis predetermines the interpretation of the results.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
f) Patients in the control group become aware of group membership and turn rebellious and alter behavior to contradict the experiment’s purpose.
