Clinical Trial Design And Implementation Part 1 Flashcards
The studies designed to first introduce a drug in human beings are:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
a) Phase 1
The studies with the highest risk to benefit ratio are:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
a) Phase 1
The studies with lowest number of subjects is likely to be:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
a) Phase 1
The studies most likely to use healthy volunteers are likely to be:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
a) Phase 1
The studies most likely to employ the use of a drug registry are likely to be:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
d) Phase 4
The studies most likely to influence the labeling of the drug and its approval by the FDA are:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
c) Phase 3
The studies which do not require an IND are:
a) Phase 1 studies
b) Phase 2 studies
c) Phase 3 studies
d) Phase 4 studies
d) Phase 4 studies
The studies which are likely to have the longest duration are:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
d) Phase 4
The studies which are likely to provide the earliest reliable information about efficacy are:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
b) Phase 2
A study enrolls 100 subjects is most likely to be:
a) Phase 1
b) Phase 2
c) Phase 3
d) Phase 4
b) Phase 2
A Phase 1 study is likely to evaluate:
a) DLT (dose limiting toxicity)
b) MTD (maximum tolerated dose)
c) Half -life
d) All of the above.
d) All of the above.
a) DLT (dose limiting toxicity)
b) MTD (maximum tolerated dose)
c) Half -life
A drug has a half-life of one day and has an initial plasma concentration of 100 mg. The concentration after four days is:
a) 50
b) 25
c) 12.5
d) 6.25
d) 6.25
A drug has a half- life of one day and a Minimum Effective Concentration (MEC) of 12.5 mg. It has an initial concentration of 100 mg. The drug will stop being effective after:
a) 1 day
b) 2 days
c) 3 days
d) 4 days
d) 4 days
The minimum number of subjects that can be enrolled in a clinical trial is:
a) 0
b) 1
c) 10
d) 100
b) 1
Phase 1 studies are likely to provide the least reliable data on efficacy because:
a) They are always conducted in healthy subjects
b) They are not measuring efficacy
c) They are too long in duration
d) Effects are unlikely at the lowest doses tested
d) Effects are unlikely at the lowest doses tested
In order to avoid serious harm to subjects in Phase 1 studies:
a) The lowest doses of drugs are tested initially
b) Cohorts with the lowest doses are evaluated before dose is escalated gradually in later cohorts
c) Subjects are frequently located in an observation center to monitor serious adverse events
d) All of the above
d) All of the above
a) The lowest doses of drugs are tested initially
b) Cohorts with the lowest doses are evaluated before dose is escalated gradually in later cohorts
c) Subjects are frequently located in an observation center to monitor serious adverse events
A washout in clinical trial denotes:
a) Treatment drugs are discontinued prior to study drugs for a period of time
b) Special hygiene measures are used in the clinical trial
c) Physician consultation is used prior to administration of study drug
d) All of the above.
a) Treatment drugs are discontinued prior to study drugs for a period of time
In a clinical trial of schizophrenia the study design calls for a washout of the current treatment drug prior to administration of the study drug. The sponsor should:
a) Inform the subject’s physician prior to administration of the study drug
b) Have an SOP for monitoring the subjects during the washout period
c) Allow a subject to self-administer any drug during the washout period
d) Make the washout period as short as possible regardless of the drug’s half-life.
b) Have an SOP for monitoring the subjects during the washout period
The drug concentration used in preclinical studies is likely to higher than in human studies by:
a) 5 fold
b) 10 fold
c) 100 fold
d) 1000 fold
d) 1000 fold
In a Phase 1 oncology study in adults the subjects are likely to be:
a) Healthy volunteers
b) Patients in remission
c) Patients with cancer who have failed standard therapy
d) Patients who are terminally ill.
c) Patients with cancer who have failed standard therapy
Patients who enroll in clinical trials on the assumption that they will be cured are subject to:
a) Self-deception
b) Misinterpretation
c) Optimism
d) Therapeutic misconception
d) Therapeutic misconception
In a Phase 3 trial subjects are randomized to a treatment group and a control (drug) group. The assignments remain unchanged for the duration of the trial. This is an example of what study design:
a) Pre-post design
b) Crossover design
c) Parallel design
d) Matched pair design
c) Parallel design
In a Phase 2 design of hypertensive drugs the following protocols implemented. The patient’s blood pressure is taken and the blood pressure is measured. The treatment drug is then given and the blood pressure is measured again. This is an example of:
a) Factorial design
b) Pre post design
c) Parallel design
d) Crossover design
b) Pre post design
In a Phase 3 trial the following treatment scheme is adopted. Group A patients are started on the treatment drug and after a period of time switched over to the control drug. Group B patients are started on the control drug and then switched over to the treatment drug. This study design is an example of:
a) Parallel design
b) Factorial design
c) Crossover design
d) Matched pair design
c) Crossover design
In a Phase 3 trial four treatment groups are identified Placebo X and active group X, Placebo Y and active group Y. The subjects are randomized to all four groups. The study design is an example of:
a) Parallel design
b) Factorial design
c) Crossover design
d) Withdrawal trial design
b) Factorial design
The Declaration of Helsinki advises this design for clinical trials whenever possible:
a) Double blinded placebo control
b) Single blinded placebo control
c) Treatment drug with a comparator control
d) Open label treatment
c) Treatment drug with a comparator control
A drug manufacturer has developed a new drug for hypertension. There are currently 15 drugs available for the treatment of hypertension. The trial design that would be most favored would be:
a) A superiority trial with the best performing drug as comparator control
b) A non-inferiorly trial with an “average” performing drug as comparator control
c) An equivalence trial with an “average” performing drug as a control
d) A placebo control trial with high statistical power.
a) A superiority trial with the best performing drug as comparator control
In a clinical trial the following design is followed. All subjects are placed on the treatment drug for a period of time. The baseline measure is then taken. Then they are randomized into two groups. One group receives the treatment drug and the other group receives a placebo. The patients are then reevaluated for the outcome measure. This design is an example of:
a) Crossover design
b) Parallel design
c) Withdrawal trial
d) Factorial design
c) Withdrawal trial
Bias in a clinical trial can result from:
a) Aspects of trial design
b) Operational aspects of the trial
c) Statistical analysis and evaluation of the results
d) All of the above
d) All of the above
a) Aspects of trial design
b) Operational aspects of the trial
c) Statistical analysis and evaluation of the results
The most common techniques utilized to prevent bias in a clinical trial are:
a) Small sample sizes and frequent measurements
b) Large sample sizes but low statistical power
c) Large sample sizes and high p values
d) Randomization and blinding
d) Randomization and blinding
