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ACRP - CCRC Exam > ICH E8 General Considerations for Clinical Trials > Flashcards

ICH E8 General Considerations for Clinical Trials Flashcards

1. Considerations for development plan 2. Basic trial design 3. Stages of drug development

1
Q

Phase 1 type of study

A

Human pharmacology

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2
Q

Phase 2 type of study

A

Therapeutic Exploratory

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3
Q

Phase 3 type of study

A

Therapeutic Confirmatory

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4
Q

Phase 4 type of study

A

Therapeutic Use
Post Marketing

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5
Q

Objective of Phase 1

A

Initial Safety
Assess Tolerance
Assess efficacy
Pharmacokinetics
Pharmacodynamics
drug interactions
Define PK/PD
-tolerability of dose ranges and nature of AEs expected

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6
Q

Objective of Phase 2

A

Explore use of safety and efficacy in targeted indication
-refine effective dose and regimen
-Provide basis for confirmatory study
-explore use of therapeutic efficacy

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7
Q

Objective of Phase 3

A

Demonstrate/ confirm efficacy in previous trials
Provide and adequate basis for Assessing the benefit/risk
establish safety profile in larger, more representative populations
basis for marketing approval
investigate subgroups / special populations
*Study endpoints selected for confirmatory studies should be clinically relevant
-confirm therapeutic benefit

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8
Q

Objective of Phase 4

A

further understand safety and efficacy
long term follow-up
increase study population
drug in real world setting
ID less common AEs
refine dosing
-go beyond drug prior demonstration

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9
Q

Single and multiple dose PK and or PD studies
(What drug Phase)

A

Phase 1

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10
Q

Drug interaction studies
(What Phase)

A

Phase 1

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11
Q

Trials in relatively short duration, well defined narrow patient populations using surrogate or pharmacologic endpoints or clinical measures

A

Phase 2

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12
Q

biomarker studies

A

Phase 2

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13
Q

Dose-response exploration studies

A

Phase 2

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14
Q

Well controlled studies to establish efficacy

A

Phase 3

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15
Q

What phase do parallel dose studies to establish efficacy in larger populations occur?

A

Phase 3

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16
Q

Clinical safety studies

A

Phase 3

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17
Q

Large simple randomized trials

A

Phase 4

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18
Q

Comparative studies (what Phase)

A

Phase 3

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19
Q

Pharmacoeconomic studies

A

Phase 4

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20
Q

What are the stages of drug development?

A

Phase 1 - Human Pharmacology
Phase 2 - Therapeutic exploratory
Phase 3 - Therapeutic confirmation
Phase 4 - Therapeutic Use/Post Marketing

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21
Q

What are the stages of drug development?

A

Phase 1: Human pharmacology

Phase 2: Therapeutic exploratory

Phase 3: Therapeutic confirmatory

Phase 4: Therapeutic use / Post Marketing

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22
Q

The ethical principles underlying clinical study management are stated in
a) Declaration of Helsinki
b) Belmont report
c) Nuremberg Code
d) CIOMS guidelines

A

The ethical principles underlying clinical study management are stated in
a) Declaration of Helsinki

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23
Q

The term non-clinical studies refers to
a) Studies in vitro cell culture models
b) Studies in organ culture
c) Studies in animal models
d) Pilot human studies

A

The term non-clinical studies refers to
c) Studies in animal models

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24
Q

Nonclinical studies
a) Should be performed in at least three species
b) Must include a disease animal model
c) Should be sufficient to indicate safety in human studies
d) Are not needed before some human studies

A

Nonclinical studies
c) Should be sufficient to indicate safety in human studies

25
Q

Toxicology studies in animal models
a) Should be reviewed by qualified experts
b) Assessed for their implications of subject safety
c) a only
d) a and b

A

Toxicology studies in animal models
d) a and b

a) Should be reviewed by qualified experts
b) Assessed for their implications of subject safety

26
Q

Clinical trial protocols should reflect
a) Reasonable costs for the clinical trial
b) Minimize sample sizes to reduce risks
c) Sound scientific design
d) The use of control groups whenever possible.

A

Clinical trial protocols should reflect
c) Sound scientific design

27
Q

The responsibility for the protection of clinical trial subjects rests with
a) IRB/IEC
b) Investigator
c) Sponsor
d) All of the above

A

The responsibility for the protection of clinical trial subjects rests with
d) all of the above

a) IRB/IEC
b) Investigator
c) Sponsor

28
Q

ICH defined Human pharmacology trial are
a) Phase I
b) Phase I|
c) Phase III
d) Phase IV

A

ICH defined Human pharmacology trial are
a) Phase I

29
Q

ICH defined Therapeutic Exploratory studies are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

A

ICH defined Therapeutic Exploratory studies are likely to be
b) Phase II

30
Q

ICH defined Therapeutic Confirmatory studies are likely to be
a) Phase I
b) Phase II
c) Phase IIII
d) Phase IV

A

ICH defined Therapeutic Confirmatory studies are likely to be
c) Phase IIII

31
Q

ICH defined Therapeutic Use studies are likely to be
a) Phase I
b) Phase II
c) Phase IIII
d) Phase IV

A

ICH defined Therapeutic Use studies are likely to be
d) Phase IV

32
Q

Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
a) Human Pharmacology
b) Therapeutic Exploratory
c) Therapeutic Confirmatory
d) Therapeutic use

A

Studies which examine dose tolerance, PK and PD aspects of a drug are likely to be
a) Human Pharmacology

33
Q

Characterization of drug’s absorption, metabolism and excretion
a) Are confined to Phase I studies
b) Can be conducted in Phase II studies if Phase I studies are inconclusive
c) Are never studied in Phase Ill studies
d) Continue throughout the development plan

A

Characterization of drug’s absorption, metabolism and excretion
d) Continue throughout the development plan

34
Q

Studies which provide the most information for confirmatory study design are part of
a) Phase I studies
b) Phase II studies
c) a only
d) b only

A

Studies which provide the most information for confirmatory study design are part of
d) b only

b) Phase II studies

35
Q

Trials of short duration in narrow patient populations using pharmacological endpoints or clinical measures are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

A

Trials of short duration in narrow patient populations using pharmacological endpoints or clinical measures are likely to be
b) Phase II

36
Q

Studies which provide the most information for risk benefit relationship of a drug are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

A

Studies which provide the most information for risk benefit relationship of a drug are likely to be
c) Phase III

37
Q

Studies on which marketing approval hinges are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

A

Studies on which marketing approval hinges are likely to be
c) Phase III

38
Q

Epidemiologic and pharmacoeconomic studies are likely to be
a) Phase I
b) Phase II
c) Phase III
d) Phase IV

A

Epidemiologic and pharmacoeconomic studies are likely to be
d) Phase IV

39
Q

Considerations for determining the nature and timing of non-clinical studies include
a) Duration and total exposure prosed in individual patients
b) Long half life
c) Route of administration
d) All of the above

A

Considerations for determining the nature and timing of non-clinical studies include
d) all of the above

a) Duration and total exposure prosed in individual patients
b) Long half life
c) Route of administration

40
Q

For first in human studies the administered dose should be determined by
a) Pharmacokinetics
b) Drug pharmacology
c) Toxicological evaluations
d) All of the above

A

For first in human studies the administered dose should be determined by
d) all of the above

a) Pharmacokinetics
b) Drug pharmacology
c) Toxicological evaluations

41
Q

Pharmacokinetic studies include all except
a) Dose response studies
b) Absorption, distribution and metabolism studies
c) Studies of the route of administration
d) Comparative bioavailability studies

A

Pharmacokinetic studies include all except
d) Comparative bioavailability studies

42
Q

Formulations of the drug should be characterized on
a) Maximum tolerated dose
b) Bioavailability
c) Half -life
d) Drug clearance

A

Formulations of the drug should be characterized on
b) Bioavailability

43
Q

Special populations are:

A

populations that require additional investigation during drug development because they have unique risk/benefit considerations
examples: pregnant and lactating women, children, geriatric populations

44
Q

Study objectives in clinical trial design may include
a) Safety and efficacy characterization
b) Pharmacokinetic and pharmacological studies
c) Physiological and biochemical studies
d) All of the above

A

Study objectives in clinical trial design may include
d) all of the above

a) Safety and efficacy characterization
b) Pharmacokinetic and pharmacological studies
c) Physiological and biochemical studies

45
Q

Study design considerations should include all of the following except
a) Cost assessment of proposed clinical trial
b) Primary and secondary endpoints and associated analyses
c) Methods to monitor adverse events
d) Use of appropriate comparators and adequate sample size

A

Study design considerations should include all of the following except
a) Cost assessment of proposed clinical trial

46
Q

Which of the following statements is true
a) Trial subjects should not enroll in more than one trial at any given time
b) Women of childbearing potential should use highly effective contraception measures
c) Male subjects should be made aware of hazard of drug exposure to their sexual partners or progeny
d) All of the above

A

Which of the following statements is true
d) all of the above

a) Trial subjects should not enroll in more than one trial at any given time
b) Women of childbearing potential should use highly effective contraception measures
c) Male subjects should be made aware of hazard of drug exposure to their sexual partners or progeny

47
Q

The major purpose of a control group is

A

to separate the effect of the treatment(s) from the effects of
other factors such as natural course of the disease, other medical care received, or observer or patient expectations

48
Q

Statistical assessment of sample size should include assessments of all of the following except
a) Clinical trial logistics and cost controls
b) Treatment effect and data variability
c) Probability of error
d) Information in population subsets or secondary endpoints

A

Statistical assessment of sample size should include assessments of all of the following except
a) Clinical trial logistics and cost controls

49
Q

Primary endpoints should have all of the following features except
a) Reflect clinically relevant effects
b) Exclude safety considerations
c) Be based on the principal objective
d) Be clearly distinguishable from secondary endpoints

A

Primary endpoints should have all of the following features except
b) Exclude safety considerations

50
Q

The response variable is:

Study endpoints are response variables chosen to ________

The primary endpoint should be capable of _____________

A

an attribute of interest that may be affected by the drug (example pharmacokinetics, pharmacodynamics, efficacy, or safety of the drug, or to the use of the drug)

are the response variables that are chosen to assess drug effects

providing clinically relevant and convincing evidence related
to the primary objective of the study

51
Q

Measurements of subjective and objective endpoints should be all of the following except
a) Accurate and precise
b) Reproducible and reliable
c) Responsive
d) Qualitative

A

Measurements of subjective and objective endpoints should be all of the following except
d) Qualitative

52
Q

Methods to minimize bias include
a) Randomization
b) Blinding
c) Compliance measures
d) All of the above

A

Methods to minimize bias include
d) All of the above

a) Randomization
b) Blinding
c) Compliance measures

53
Q

The protocol should include all of the following except
a) A section for assessment of conflict of interest
b) Analysis plan appropriate to objectives and design
c) Statistical methods
d) Plans for interim analysis

A

The protocol should include all of the following except
a) A section for assessment of conflict of interest

54
Q

Phase IV protocols generally follow
a) Phase I protocols
b) Phase Il protocols
c) Phase Ill protocols
d) Approved use by the regulatory agency

A

Phase IV protocols generally follow
d) Approved use by the regulatory agency

55
Q

Response variables are closely related to
a) Study endpoints
b) Primary objectives
c) Secondary Objectives
d) Statistical Plan

A

Response variables are closely related to
a) Study endpoints

56
Q

Phase 1 studies of a cancer drug are done in
a) Healthy volunteers
b) Subjects with cancer
c) Subjects with cancer who have failed conventional therapy
d) Subjects with cancer with more than a year’s anticipated survival

A

Phase 1 studies of a cancer drug are done in
b) Subjects with cancer

57
Q

Methods to be used in assessing patient drug use and compliance are best
a) Discussed verbally with the subject
b) Need not be mentioned in the informed consent
c) Need not be discussed with subjects
d) Included in the study protocol

A

Methods to be used in assessing patient drug use and compliance are best
d) Included in the study protocol

58
Q

Planning of clinical trials with children
a) Should await the results of a trials in adults
b) Should be planned with children in mind from the very outset
c) Should exclude children ages
d) Should be planned predominantly in adolescents

A

Planning of clinical trials with children
b) Should be planned with children in mind from the very outset

ACRP - CCRC Exam (14 decks)

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