General Considerations for Clinical Trials Flashcards
The ethical principles underlying clinical study management are stated in
A.) Declaration of Helsinki
B.) Belmont report
C.) Nuremberg Code
D.) CIOMS guidelines
A.) Declaration of Helsinki
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
C.) Studies in animal models
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
C.) Should be sufficient to indicate safety in human studies
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
D.) A and B
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
C.) Sound scientific design
The responsibility for the protection of clinical trial subjects rests with
A.) IRB/IEC
B.) Investigator
C.) Sponsor
D.) All of the above
D.) All of the above
ICH defined Human pharmacology trial are
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
A.) Phase I
ICH defined Therapeutic Exploratory studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
B.) Phase II
ICH defined Therapeutic Confirmatory studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
C.) Phase III
ICH defined Therapeutic Use studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
D.) Phase IV
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.) Human Pharmacology
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 III studies
D.) Continue throughout the development plan
D.) Continue throughout the development plan
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
D.) B Only
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
B.) Phase II
Studies which provide the most information for risk benefit relationship of a drug likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
C.) Phase III
Studies on which marketing approval hinges are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
C.) Phase III
Epidemiologic and pharmacoeconomic studies are likely to be
A.) Phase I
B.) Phase II
C.) Phase III
D.) Phase IV
D.) Phase IV
Considerations for determining the nature and timing of non-clinical studies include
A.) Duration and total exposure proposed in individual patients
B.) Long half life
C.) Route of administration
D.) All of the above
D.) All of the above
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
D.) All of the above
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
D.) Comparative bioavailability studies
Formulations of the drug should be characterized on
A.) Maximum tolerated dose
B.) Bioavailability
C.) Half life
D.) Drug clearance
B.) Bioavailability
Special populations to be considered in clinical trials is defined in ICH E8 to include all except
A.) Pregnant women
B.) Elderly
C.) Nursing women
D.) Children
B.) Elderly
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
D.) All of the above
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.) Cost assessment of proposed clinical trial
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
D.) All of the above
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
A.) A group of a distinct age composition
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.) Clinical trial logistics and cost controls
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
B.) Exclude safety considerations
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
D.) Qualitative
Methods to minimize bias include
A.) Randomization
B.) Blinding
C.) Compliance measures
D.) All of the above
D.) All of the above
The protocol should include all of the following except
A.) A section for assessment of conflict of interest
B.) Analysis plan appropriate to objective and design
C.) Statistical methods
D.) Plans for interim analysis
A.) A section for assessment of conflict of interest
Phase IV protocols generally follow
A.) Phase I protocols
B.) Phase II protocols
C.) Phase III protocols
D.) Approved use by the regulatory agency
D.) Approved use by the regulatory agency
Response variables are closely related to
A.) Study endpoints
B.) Primary objectives
C.) Secondary objectives
D.) Statistical plan
A.) Study endpoints
Phase I studies of a cancer drug are done
A.) Healthy volunteers
B.) Subjects with cancer
C.) Subjects with cancer who have failed conventional
D.) Subjects with cancer with more than a year’s anticipated survival
B.) Subjects with cancer
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
D.) Included in the study protocol
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
B.) Should be planned with children in mind from the very outset
