General Considerations for Clinical Trials

Question 1

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

Answer 1

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

Question 2

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

Answer 2

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

Question 3

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

Answer 3

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

Question 4

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

Answer 4

Toxicology studies in animal models
d) a and b

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

Question 5

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.

Answer 5

Clinical trial protocols should reflect
c) Sound scientific design

Question 6

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

Answer 6

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

a) IRB/IEC
b) Investigator
c) Sponsor

Question 7

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

Answer 7

ICH defined Human pharmacology trial are
a) Phase I

Question 8

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

Answer 8

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

Question 9

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

Answer 9

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

Question 10

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

Answer 10

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

Question 11

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

Answer 11

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

Question 12

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

Answer 12

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

Question 13

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

Answer 13

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

b) Phase II studies

Question 14

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

Answer 14

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

Question 15

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

Answer 15

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

Question 16

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

Answer 16

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

Question 17

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

Answer 17

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

Question 18

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

Answer 18

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

Question 19

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

Answer 19

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

Question 20

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

Answer 20

Pharmacokinetic studies include all except
d) Comparative bioavailability studies

Question 21

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

Answer 21

Formulations of the drug should be characterized on
b) Bioavailability

Question 22

Special populations to be considered in clinical trial is defined in ICH E8 to include all except
a) Pregnant women
b) Elderly
c) Nursing women
d) Children

Answer 22

Special populations to be considered in clinical trial is defined in ICH E8 to include all except
b) Elderly

Question 23

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

Answer 23

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

Question 24

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

Answer 24

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

Question 25

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

Answer 25

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

Question 26

A control group may consist of all of the following except
a) A group of a distinct age composition
b) A placebo
c) Active control
d) Different doses of the drug

Answer 26

A control group may consist of all of the following except
a) A group of a distinct age composition

Question 27

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

Answer 27

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

Question 28

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

Answer 28

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

Question 29

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

Answer 29

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

Question 30

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

Answer 30

Methods to minimize bias include
d) All of the above

a) Randomization
b) Blinding
c) Compliance measures

Question 31

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

Answer 31

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

Question 32

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

Answer 32

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

Question 33

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

Answer 33

Response variables are closely related to
a) Study endpoints

Question 34

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

Answer 34

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

Question 35

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

Answer 35

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

Question 36

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

Answer 36

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