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ACRP CCRC Exam Prep > Statistical Priniciples in Clinical Trials > Flashcards

Statistical Priniciples in Clinical Trials Flashcards

1
Q

The primary concern in a confirmatory trial is
a) Efficacy
b) Safety
c) Pharmacodynamics
d) Pharmacokinetics

A

The primary concern in a confirmatory trial is
a) Efficacy

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2
Q

Statistical principles are relevant to
a) Phase I trials
b) Phase Il trials
c) Phase Ill trials
d) All of the above

A

Statistical principles are relevant to
d) All of the above

a) Phase I trials
b) Phase Il trials
c) Phase Ill trials

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3
Q

Bias is defined as
a) Error in miscalculation of the final drug effect
b) Trend to extrapolation in missing values
c) Deviation in the estimation of a treatment effect from its true value
d) Failure to use a complete data set for analysis

A

Bias is defined as
c) Deviation in the estimation of a treatment effect from its true value

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4
Q

Factors associated with bias can include
a) Study design
b) Study conduct
c) Data analysis and interpretation
d) All of the above.

A

Factors associated with bias can include
d) All of the above

a) Study design
b) Study conduct
c) Data analysis and interpretation

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5
Q

Robustness refers to all of the following except
a) Sensitivity of the conclusions to various limitations of data
b) Sensitivity to the conclusions data to various limitations of assumptions
c) Lack of an effect of study conclusions to alternative analytic approaches
d) The health status of the subjects in the clinical trial

A

Robustness refers to all of the following except
d) The health status of the subjects in the clinical trial

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6
Q

A development plan purpose is to
a) Find a dose range that is simultaneously safe and effective
b) Prove that the risk benefit relationship is acceptable
c) Identify the subjects who would most benefit and indications for the use
d) All of the above.

A

A development plan purpose is to
d) All of the above

a) Find a dose range that is simultaneously safe and effective
b) Prove that the risk benefit relationship is acceptable
c) Identify the subjects who would most benefit and indications for the use

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7
Q

In a confirmatory trial the following apply
a) Phase 1 results are verified in phase 2 trials
b) Test the key hypothesis, effect size and clinical significance
c) Conduct the trial in a large sample of subjects
d) The design is that described for the use of an approved drug

A

In a confirmatory trial the following apply
b) Test the key hypothesis, effect size and clinical significance

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8
Q

Exploratory trials (select all that apply)
a) Explore a wide range of hypotheses
b) Provide formal proof of efficacy
c) Need flexible designs
d) Are designed to explore new uses for an approved drug

A

Exploratory trials (select all that apply)
a) Explore a wide range of hypotheses
c) Need flexible designs

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9
Q

The population of a clinical trial reflects all of the following except:
a) May be narrow in early trials to maximize effects
b) Tend to mirror the target disease population in later trials
c) Is always significantly large in Phase 1 trials to ensure reliable toxicology results
d) Must balance eligibility criteria and treatment effects

A

The population of a clinical trial reflects all of the following except:
c) Is always significantly large in Phase 1 trials to ensure reliable toxicology results

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10
Q

The primary variable reflects all of the following except
a) Must provide convincing evidence for the primary objective
b) Is usually the efficacy variable
c) Must provide significant support for secondary variables
d) May be restricted in some trials only to safety and tolerability

A

The primary variable reflects all of the following except
c) Must provide significant support for secondary variables

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11
Q

Secondary variables must
a) Be supportive measurements related to the primary objective
b) Need to have their role and importance defined carefully in a clinical trial
c) Should be limited to answering a limited number of questions in the trial.
d) All of the above.

A

Secondary variables must
d) All of the above

a) Be supportive measurements related to the primary objective
b) Need to have their role and importance defined carefully in a clinical trial
c) Should be limited to answering a limited number of questions in the trial.

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12
Q

Global assessment variables reflect all of the following except
a) They are developed to measure the overall usefulness of treatment
b) Require that a scale be developed and detailed in the protocol
c) Should define how to assign subjects to a unique category on a scale
d) Are never used as a primary variable in most clinical trials

A

Global assessment variables reflect all of the following except
d) Are never used as a primary variable in most clinical trials

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13
Q

Which of the following statements regarding surrogate variables is false?
a) They are used when direct observation of clinical efficacy is not practical
b) May show an effect in the absence of a clinical outcome
c) May not yield a quantitative measure of clinical benefit
d) Often allow for an assessment of benefits relative to adverse effects.

A

Which of the following statements regarding surrogate variables is false?
d) Often allow for an assessment of benefits relative to adverse effects.

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14
Q

For a surrogate variable to be reliable, they should
a) Have a plausible relationship to clinical outcome
b) Be supported by epidemiologic evidence
c) Reflect a treatment effect that corresponds to clinical outcome
d) All of the above

A

For a surrogate variable to be reliable, they should
d) All of the above

a) Have a plausible relationship to clinical outcome
b) Be supported by epidemiologic evidence
c) Reflect a treatment effect that corresponds to clinical outcome

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15
Q

A double blind trial is one in which the following are unaware of the treatment received
a) Sponsor
b) Investigator
c) Subject
d) All of the above

A

A double blind trial is one in which the following are unaware of the treatment received
d) All of the above

a) Sponsor
b) Investigator
c) Subject

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16
Q

In a double blind trial the person who should be unaware of the treatment should not be involved in assessing
a) Eligibility
b) Endpoints
c) Compliance
d) All of the above

A

In a double blind trial the person who should be unaware of the treatment should not be involved in assessing
d) All of the above

a) Eligibility
b) Endpoints
c) Compliance

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17
Q

In a single blind trial the person who is unaware of the treatment is
a) Subject
b) Investigator
c) Monitor
d) Clinical coordinator

A

In a single blind trial the person who is unaware of the treatment is
a) Subject

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18
Q

In an open label trial the persons who should be aware that the treatment is being administered are
a) Subject and investigator
b) Pharmacist and investigator
c) Sponsor and investigator
d) Monitor and investigator

A

In an open label trial the persons who should be aware that the treatment is being administered are
a) Subject and investigator

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19
Q

Breaking the blind for a single subject
a) Implies breaking the blind for the study group
b) May be done at the discretion of the monitor
c) Should be implemented when deemed essential for subject’s care
d) Always involves a serious adverse event

A

Breaking the blind for a single subject
c) Should be implemented when deemed essential for subject’s care

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20
Q

In a parallel group design the subjects
a) Randomized to two arms each with a different treatment
b) Are evaluated before and after drug administration
c) Are randomized to a sequence of two treatments
d) Are evaluated simultaneously for varying combinations of treatments

A

In a parallel group design the subjects
a) Randomized to two arms each with a different treatment

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21
Q

In a crossover design the subjects
a) Randomized to two arms each with a different treatment
b) Are evaluated before and after drug administration
c) Are randomized to a sequence of two treatments
d) Are evaluated simultaneously for varying combinations of treatments

A

In a crossover design the subjects
c) Are randomized to a sequence of two treatments

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22
Q

In a pre- post design the subjects
a) Randomized to two arms each with a different treatment
b) Are evaluated before and after drug administration
c) Are randomized to a sequence of two treatments
d) Are evaluated simultaneously for varying combinations of treatments

A

In a pre- post design the subjects
b) Are evaluated before and after drug administration

23
Q

In a factorial design the subjects
a) Randomized to two arms each with a different treatment
b) Are evaluated before and after drug administration
c) Are randomized to a sequence of two treatments
d) Are evaluated simultaneously for varying combinations of treatments

A

In a factorial design the subjects
d) Are evaluated simultaneously for varying combinations of treatments

24
Q

The most commonly used study design in clinical trials is:
a) Parallel design
b) Crossover design
c) Pre-Post design
d) Factorial design

A

The most commonly used study design in clinical trials is:
a) Parallel design

25
Q

For a successful crossover design:
a) Carryover form a pervious treatment should be minimized
b) The disease should be chronic and stable
c) Drug effects should develop fully within the treatment period
d) All of the above

A

For a successful crossover design:
d) All of the above

a) Carryover form a pervious treatment should be minimized
b) The disease should be chronic and stable
c) Drug effects should develop fully within the treatment period

26
Q

Multi center trials have the following features except
a) They are more efficient as they accrue sufficient subjects
b) May facilitate generalization of findings
c) May present the only method for accruing subjects in rare diseases
d) Are easily administered for uniform implementation of the protocol

A

Multi center trials have the following features except
d) Are easily administered for uniform implementation of the protocol

27
Q

Drug efficacy is best established by
a) Demonstrating superiority to placebo in a placebo control trial
b) Demonstrating superiority in an active control trial
c) Demonstrating a dose -response relationship
d) All of the above

A

Drug efficacy is best established by
d) All of the above

a) Demonstrating superiority to placebo in a placebo control trial
b) Demonstrating superiority in an active control trial
c) Demonstrating a dose -response relationship

28
Q

A placebo controlled trial would be considered unethical if
a) The drug has been shown to be efficacious in a superiority trial
b) The drug has been shown equivalent to active control in a non-inferiority trial
c) Drug has shown serious side effects in preclinical studies
d) All of the above

A

A placebo controlled trial would be considered unethical if
a) The drug has been shown to be efficacious in a superiority trial

29
Q

An equivalence or non-inferiority trial is one in which
a) Efficacy of a test drug is no worse than an active comparator
b) Multiple doses of a test drug are compared to multiple doses of as standard drug
c) a only
d) a and b

A

An equivalence or non-inferiority trial is one in which
d) a and b

a) Efficacy of a test drug is no worse than an active comparator
b) Multiple doses of a test drug are compared to multiple doses of as standard drug

30
Q

An active control is best represented by
a) Any drug that has shown activity against the disease
b) A drug that has been shown to be non-inferior in an equivalence trial
c) A drug that has shown efficacy in a superiority trial
d) All of the above

A

An active control is best represented by
c) A drug that has shown efficacy in a superiority trial

31
Q

In assessing sample size, the items that need to be specified include all except
a) The primary variable and test statistic
b) The null and alternative hypothesis
c) The projected cost of the trial for the designated sample size
d) Type I and Type Il errors

A

In assessing sample size, the items that need to be specified include all except
c) The projected cost of the trial for the designated sample size

32
Q

The probability of erroneously rejecting the null hypothesis is described as
a) Type I error
b) Type Il error
c) Type Ill error
d) Risk assessment

A

The probability of erroneously rejecting the null hypothesis is described as
a) Type I error

33
Q

The probability of erroneously failing to reject the null hypothesis is described as
a. Type I error
b. Type Il error
c. Type Ill error
d. Risk assessment

A

The probability of erroneously failing to reject the null hypothesis is described as
b. Type Il error

34
Q

Data collection in a clinical trial usually employs
a) Paper case record forms
b) Remote site monitoring
c) Medical computer systems and electronic transfer
d) All of the above

A

Data collection in a clinical trial usually employs
d) All of the above

a) Paper case record forms
b) Remote site monitoring
c) Medical computer systems and electronic transfer

35
Q

The type of monitoring in a confirmatory clinical trial may include
a) Oversight of the quality of the clinical trial
b) Breaking the blind for treatment comparison and interim analysis
c) a only
d) a and b

A

The type of monitoring in a confirmatory clinical trial may include
d) a and b

a) Oversight of the quality of the clinical trial
b) Breaking the blind for treatment comparison and interim analysis

36
Q

Oversight of the quality of a trail involves review of all of the following except
a) Protocol adherence
b) Conflict of interest
c) Patient accrual and retention
d) Review of design assumptions

A

Oversight of the quality of a trail involves review of all of the following except
b) Conflict of interest

37
Q

Inclusion and exclusion criteria
a) Can be set to maximize enrollment
b) Are independent of preclinical studies
c) Should remain constant during a clinical trial
d) May change as needed during a clinical trial

A

Inclusion and exclusion criteria
c) Should remain constant during a clinical trial

38
Q

The ideal data analysis set is one in which
a) Procedures are followed perfectly
b) Data records are complete
c) There is no loss to patient follow up
d) All of the above

A

The ideal data analysis set is one in which
d) All of the above

a) Procedures are followed perfectly
b) Data records are complete
c) There is no loss to patient follow up

39
Q

Irregularities in the data analysis set may arise from
a) Protocol violations
b) Patient withdrawals
c) Missing values
d) All of the above

A

Irregularities in the data analysis set may arise from
d) All of the above

a) Protocol violations
b) Patient withdrawals
c) Missing values

40
Q

The intention to treat analysis set includes
a) All treated subjects
b) Only subjects with complete drug treatments
c) Subjects who have undergone the minimum number of acceptable trial visits
d) All randomized subjects

A

The intention to treat analysis set includes
d) All randomized subjects

41
Q

The Per protocol analysis data set includes
a) All randomized subjects
b) All subjects who have not undergone SAEs
c) Evaluable subjects compliant with the protocol
d) Subjects with no missed visits as specified in the schedule of assessments

A

The Per protocol analysis data set includes
c) Evaluable subjects compliant with the protocol

42
Q

Criteria used for inclusion of data in the per protocol data set include
a) Completion of minimal exposure to treatment
b) Available measure of the primary variables
c) Absence of protocol violations and eligibility criteria
d) All of the above

A

Criteria used for inclusion of data in the per protocol data set include
d) All of the above

a) Completion of minimal exposure to treatment
b) Available measure of the primary variables
c) Absence of protocol violations and eligibility criteria

43
Q

In confirmatory trials, it is usual to analyze
a) Full analysis set only
b) Per protocol Set only
c) Full analysis and per protocol sets
d) Null hypothesis analysis set

A

In confirmatory trials, it is usual to analyze
c) Full analysis and per protocol

44
Q

Missing values in a data set
a) Are generally discounted in data analysis
b) Are eliminated by extrapolation
c) Contribute to bias
d) Have no effect on hypothesis testing

A

Missing values in a data set
c) Contribute to bias

45
Q

Covariates in a statistical analysis may include
a) Variation in populations between centers in a multi-center trail
b) Variations in age subgroups
c) Variations by gender
d) All of the above

A

Covariates in a statistical analysis may include
d) All of the above

a) Variation in populations between centers in a multi-center trail
b) Variations in age subgroups
c) Variations by gender

46
Q

Pre analysis review should include considerations of
a) Exclusion of subjects from the data set
b) Transformation of the variables
c) Impact an statistical treatment of outliers
d) All of the above

A

Pre analysis review should include considerations of
d) All of the above

a) Exclusion of subjects from the data set
b) Transformation of the variables
c) Impact an statistical treatment of outliers

47
Q

Safety and tolerability of the drug are best assessed in
a) Phase I trials
b) Phase Il trials
c) Continuously during drug development
d) Phase Ill trials

A

Safety and tolerability of the drug are best assessed in
c) Continuously during drug development

48
Q

Blind review occurs
a) At various stages of a clinical trial
b) After study close out visit for all sites has been completed
c) At pre-specified intervals
d) Between trial completion and breaking of the blind

A

Blind review occurs
d) Between trial completion and breaking of the blind

49
Q

The term double dummy refers to
a) Double blinded trial
b) Placebo controlled trial
c) Technique to retain the blind when administering supplies to non-identical groups
d) All of the above

A

The term double dummy refers to
c) Technique to retain the blind when administering supplies to non-identical groups

50
Q

The DSMB monitors
a) The safety data
b) Patient accrual
c) Data accuracy
d) Missing data

A

The DSMB monitors
a) The safety data

51
Q

The DSMB can recommend
a) Continuation, modification or termination of a sponsor’s trial
b) The continued enrollment of patients in light of safety events
c) The submission of serious adverse safety events for regulatory review
d) The submission of serious adverse safety events to the IRB.

A

The DSMB can recommend
a) Continuation, modification or termination of a sponsor’s trial

52
Q

Methods to avoid the bias in a clinical trial generally involve
a) Single-blind only
b) Double-blind only
c) Single or double blind
d) Open label

A

Methods to avoid the bias in a clinical trial generally involve
c) Single or double blind

53
Q

A trial designed on the basis of some evidence of benfits is leily (to bring to completion) to be
a) Exploratory trial
b) Confirmatory trial
c) Phase IV trial
d) Open label trial

A

A trial designed on the basis of some evidence of benfits is leily to be
b) Confirmatory trial

54
Q

Mutlicenter trials can be implemented for
a) Open label trials
b) Exploratory trials
c) Confirmatory trials
d) Any stage of clinical drug development

A

Mutlicenter trials can be implemented for
d) Any stage of clinical drug development

ACRP CCRC Exam Prep (10 decks)

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