Clinical Investigation of Pediactric Population

Question 1

The decision to proceed with a pediatric drug development program includes all of the following except
a) Prevalence and seriousness of the condition
b) The availability and suitability of alternative treatment
c) The adverse event profile of alternative treatments
d) Results of phase I trials in adults

Answer 1

The decision to proceed with a pediatric drug development program includes all of the following except
d) Results of phase I trials in adults

Question 2

The decision to proceed with a pediatric drug development program includes all of the following except
a) Novel or unique features of the proposed drug
b) The age ranges of the likely pediatric patients
c) Non clinical safety issues and implications for formulation development
d) Pilot studies in a small relevant group of children.

Answer 2

The decision to proceed with a pediatric drug development program includes all of the following except
d) Pilot studies in a small relevant group of children.

Question 3

Formulation of pediatric drugs may require the need for
a) Chewable tablets and liquid formulations
b) Safe and easily injectable formulations
c) Frequent use of suspensions
d) All of the above.

Answer 3

Formulation of pediatric drugs may require the need for
d) All of the above

a) Chewable tablets and liquid formulations
b) Safe and easily injectable formulations
c) Frequent use of suspensions

Question 4

The timing of pediatric studies of a drug is dependent on
a) Completion of Phase 1 trials in adults
b) Successful non clinical studies
c) Type of disease and safety and efficacy of alternate treatments
d) Known safety profile of the drug in the adult population

Answer 4

The timing of pediatric studies of a drug is dependent on
c) Type of disease and safety and efficacy of alternate treatments

Question 5

Development of drug for a disease exclusively affecting the pediatric population requires
a) The entire development program in children only
b) Safety and tolerability data obtained in adults
c) a only
d) a and b

Answer 5

Development of drug for a disease exclusively affecting the pediatric population requires
c) a only

a) The entire development program in children only

Question 6

Pharmacokinetic studies of a pediatric drug requires
a) Studies in adults with the disease
b) Studies in pediatric populations with the disease
c) Studies in healthy children
d) Studies preferably carried out in older children or adolescents

Answer 6

Pharmacokinetic studies of a pediatric drug requires
b) Studies in pediatric populations with the disease

Question 7

Dosing recommendations for pediatric drugs are based on
a) Body area
b) Renal clearance
c) Liver metabolism
d) Mg/kg body weight

Answer 7

Dosing recommendations for pediatric drugs are based on
d) Mg/kg body weight

Question 8

The institutional review board in the United States sets the blood volume that can be obtained from a child
a) Based on institutional policy
b) Based on guidelines in DHHS regulations
c) Based on disease severity
d) Based on the age of the child.

Answer 8

The institutional review board in the United States sets the blood volume that can be obtained from a child
b) Based on guidelines in DHHS regulations

Question 9

The typical restriction on blood draws from children in the United States is set at
a) No more than once weekly
b) No more than twice weekly
c) No more than three time weekly
d) No more than four times weekly

Answer 9

The typical restriction on blood draws form children in the United States is set at
b) No more than twice weekly

Question 10

The amount of blood volume that may be obtained form a child in the United States is set at
a) No more than 50 ml in an eight week period
b) No more than a 100 ml in one month
c) No more than 20 ml in one week
d) Nor more than one unit in four weeks

Answer 10

The amount of blood volume that may be obtained form a child in the United States is set at
a) No more than 50 ml in an eight week period

Question 11

The amount of blood obtained from a child in a clinical trial may be minimized by the following methods
a) Use of sensitive assays and indwelling catheters for sampling and analyzing drugs and metabolites
b) Use of laboratories specialized in handling small blood volumes
c) Collection of research samples at the same time as clinical care samples
d) All of the above

Answer 11

The amount of blood obtained from a child in a clinical trial may be minimized by the following methods
d) All of the above

a) Use of sensitive assays and indwelling catheters for sampling and analyzing drugs and metabolites
b) Use of laboratories specialized in handling small blood volumes
c) Collection of research samples at the same time as clinical care samples

Question 12

Phase IV studies in pediatric populations
a) Are not required as there is no regulation that outlines the need
b) Are rarely done because safety information is already documented in Phase Ill trials
c) Are recommended only if Phase IV studies in the adult population have not been done
d) Are particularly important as the pediatric database is limited at the time of approval

Answer 12

Phase IV studies in pediatric populations
d) Are particularly important as the pediatric database is limited at the time of approval

Question 13

Age classifications of pediatric subjects in ICH includes
a) Preterm newborn infants
b) Term newborn infants
c) Infants and toddlers
d) All of the above

Answer 13

Age classifications of pediatric subjects in ICH includes
d) All of the above

a) Preterm newborn infants
b) Term newborn infants
c) Infants and toddlers

Question 14

The definition of a child as classified by age in the United States
a) Is specified in the Federal regulations
b) Is designated as being the same in countries that are signatories to ICH guidelines
c) Varies by state in the United States
d) Is set at 18 years as a universal standard

Answer 14

The definition of a child as classified by age in the United States
c) Varies by state in the United States

Question 15

ICH defines an adolescent as a person who is
a) Between 14 and 18 years of age
b) Between 12 to 16-18 years of age
c) Between 13 and 17 years of age
d) Between 16 to 18 years of age

Answer 15

ICH defines an adolescent as a person who is
b) Between 12 to 16-18 years of age

Question 16

Features pertinent to drug metabolism in a Preterm new born include
a) Immaturity of renal and hepatic clearance mechanism
b) Drug binding and displacement from proteins
c) Penetration into the CNS
d) Unique neonatal conditions
e) Rapid maturation of physiologic processes that radically influence drug dosing
f) Transdermal absorption of drugs
g) All of the above

Answer 16

Features pertinent to drug metabolism in a Preterm new born include
g) All of the above

a) Immaturity of renal and hepatic clearance mechanism
b) Drug binding and displacement from proteins
c) Penetration into the CNS
d) Unique neonatal conditions
e) Rapid maturation of physiologic processes that radically influence drug dosing
f) Transdermal absorption of drug

Question 17

In term new born infants features of drug metabolism include
a) Stable renal and hepatic clearance compared to preterm newborns
b) Oral administration of the drug is predictable and preferred
c) Dose adjustments are unlikely to be needed in the course of a clinical trial
d) Immaturity of the blood brain barrier may give rise to CNS toxicity

Answer 17

In term new born infants features of drug metabolism include
d) Immaturity of the blood brain barrier may give rise to CNS toxicity

Question 18

In infants and toddlers, features of drug metabolism include
a) Hepatic and renal clearance are stable
b) Oral absorption is as unreliable as in newborns
c) The CNS maturation is nearly complete
d) Clearance of drugs on a mg/kg basis may exceed adult values

Answer 18

In infants and toddlers, features of drug metabolism include
d) Clearance of drugs on a mg/kg basis may exceed adult values

Question 19

In children 2-11 years of age factors to consider in clinical trials include
a) Tanner staging for puberty
b) Recreational use of drugs, alcohol and tobacco
c) a only
d) Both a and b

Answer 19

In children 2-11 years of age factors to consider in clinical trials include
d) Both a and b

a) Tanner staging for puberty
b) Recreational use of drugs, alcohol and tobacco

Question 20

Factors to consider in measuring the effect of a pediatric drug of children between 2 and 11 years of age include all of the following except
a) Skeletal muscle growth
b) Weight gain
c) School attendance and school performance
d) Interpersonal interactions with other children

Answer 20

Factors to consider in measuring the effect of a pediatric drug of children between 2 and 11 years of age include all of the following except
d) Interpersonal interactions with other children

Question 21

IRBs reviewing pediatric clinical trials
a) Are required to have a pediatrician according to the regulations
b) May review the studies without a pediatrician
c) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issues
d) Should have pediatrician who is trained in the disease subspecialty of the clinical trial.

Answer 21

IRBs reviewing pediatric clinical
c) Should have a member or experts consulted who are knowledgeable in pediatric ethics and psychosocial issues

Question 22

Regarding recruitment of in pediatric clinical trials all of the following are true except
a) Inappropriate inducements should be avoided
b) Reimbursements and subsistence costs may be covered
c) The compensation should be divided between the parent and the child
d) Any level of compensation no matter how small should be reviewed by the IRB.

Answer 22

Regarding recruitment of in pediatric clinical trials all of the following are true except
c) The compensation should be divided between the parent and the child

Question 23

In pediatric clinical trials :
a) The assent of the child always overrides the permission of the parent
b) The pediatric subject is usually legally incapable of providing informed consent
c) The approval of both parents is required
d) A witness to the consent process is mandatory

Answer 23

In pediatric clinical trials :
b) The pediatric subject is usually legally incapable of providing informed consent

Question 24

In pediatric clinical trials
a) Participants should sign assent or consent depending on their intellectual maturity
b) Participants should always be made aware of their right to decline
c) a only
d) Both a and b

Answer 24

In pediatric clinical trials
d) Both a and b

a) Participants should sign assent or consent depending on their intellectual maturity
b) Participants should always be made aware of their right to decline

Question 25

Withdrawal of pediatric subject from a clinical trail
a) Is always permitted
b) May be overridden by the investigator or parent for serious or life threatening diseases
c) Depends on the regulations of the country
d) Requires the consent of both parents

Answer 25

Withdrawal of pediatric subject from a clinical trail
b) May be overridden by the investigator or parent for serious or life threatening diseases

Question 26

Approaches to minimize risks in pediatric clinical trials include all of the following except
a) Minimize the number of study subjects b)
Maximize the number of study subjects
c) Minimize study procedures
d) Employ good study designs

Answer 26

Approaches to minimize risks in pediatric clinical trials include all of the following except
a) Minimize the number of study subjects

Question 27

In the United States pediatric clinical research studies are designated different categories
based on
a) Disease severity
b) Complexity of study design
c) Assessment of the level of risk
d) Age range of the study participants

Answer 27

In the United States pediatric clinical research studies are designated different categories
based on
c) Assessment of the level of risk

Question 28

Under ICH guidelines approaches to minimize distress in pediatric clinical studies include all of the following except
a) Use of personnel skilled in pediatric procedures
b) Use of age appropriate gifts as compensation
c) A setting with furniture and play equipment appropriate to the age
d) Use of an environment familiar to the child where they have received clinical care

Answer 28

Under ICH guidelines approaches to minimize distress in pediatric clinical studies include all of the following except
b) Use of age appropriate gifts as compensation

Question 29

Approaches to minimize discomfort of procedures in pediatric clinical trials includes all of the following except
a) Topical anesthesia to place I catheters
b) Use of indwelling catheters
c) Use of anesthesia in MRI procedures
d) Collection of research samples at the same time as clinical care samples are collected.

Answer 29

Approaches to minimize discomfort of procedures in pediatric clinical trials includes all of the following except
c) Use of anesthesia in MRI procedures

Question 30

Procedures to minimize the amount of blood sampled in pediatric clinical trials include :
a) Population PK sampling
b) Sparse sampling
c) In dwelling catheters
d) All of the above

Answer 30

Procedures to minimize the amount of blood sampled in pediatric clinical trials include :
d) All of the above

a) Population PK sampling
b) Sparse sampling
c) In dwelling catheters

Question 31

Phase IV studies in the pediatric population differ from those in adult populations because
a) They are required to assess the effects on development
b) They are less likely to yield safety information because of age variation
c) The large samples required for such studies are hard to find in pediatric populations
d) Unlike adult populations regulations do not require Phase IV pediatric studies

Answer 31

Phase IV studies in the pediatric population differ from those in adult populations because
a) They are required to assess the effects on development

Question 32

In designing a study in which participants have mature hepatic and renal function you would choose
a) Neonates
b) Preterm infants
c) Participants between the ages of 1-2 years
d) Children

Answer 32

In designing a study in which participants have mature hepatic and renal function you would choose
d) Children

Question 33

In ICH children are defined as between the ages of
a) 7-13 years
b) 2-6 years
c) 4-11 years
d) 2-11 years

Answer 33

In ICH children are defined as between the ages of
d) 2-11 years

Question 34

A major problem in studies with adolescents is
a) Drug addiction
b) Peer pressure
c) Conflicting school and personal schedules
d) Noncompliance

Answer 34

A major problem in studies with adolescents is
d) Noncompliance