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CNPR: Pharmaceutical Sales Training Manual - Revised 17th Edition > Chapter 11: Clinical Trials > Flashcards

Chapter 11: Clinical Trials Flashcards

1
Q

What is a clinical trial?

A

A study of human subjects that is intended to ascertain an investigational product’s safety and efficacy.

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2
Q

What are the seven ethical considerations of clinical trials?

A

1.) social value.
2.) scientific validity.
3.) fair subject selection.
4.) informed consent.
5.) favorable risk benefit ratio.
6.) independent review board/independent ethics committee (IRB/IRC)
7.) respect for human subjects.

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3
Q

What is Phase I of a clinical trial?

A

The first experiment in which a drug is tested on the human body.

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4
Q

What is Phase II of a clinical trial?

A

Examines the safety and effectiveness of the drug in the targeted disease group.

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5
Q

What is Phase III of a clinical trial?

A

This confirms the efficacy of the drug in a much larger patient group (several hundred to thousands).

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6
Q

What is Phase IV of a clinical trial?

A

The post marketing approval trials to monitor the efficacy and side effects of the drug in an uncontrolled real-life situation.

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7
Q

Who is the investigator?

A

The person who conducts the trial.

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8
Q

What is an investigators brochure?

A

A collection of information prepared and updated by the sponsor for the investigator. Consists of all the data relevant to the drug under investigation.

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9
Q

What is informed consent?

A

Subjects should be thoroughly educated about the study’s aims, methods, risks, benefits, and alternatives.

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10
Q

What is protocol?

A

This document set out how a trial is to be conducted.

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11
Q

What is inclusion and exclusion criteria?

A

These criteria set out the conditions, under which a person may or may not be included in the trial.

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12
Q

What a case report form?

A

Document or file in which all the information relating to a subject is recorded

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13
Q

What is randomization, placebo-controlled and double blinded?

A

Not knowing who receives the placebo and who receives the drug. Less biased and the groups are random.

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14
Q

What is monitoring?

A

All processes are recorded in accordance with GCP and standard operating procedures. Info is recorded in case report forms.

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15
Q

What are adverse events?

A

Unintended reactions of the subjects as a consequence of taking the drug or placebo.

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16
Q

What are statistics?

A

The groups or sub groups to be studied. The frequencies, dosages, and the markers to monitor drug advocacy are important factors to consider.

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17
Q

What is the sponsor?

A

This is the organization or individual that initiates the clinical trial and finances the study.

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18
Q

What is the clinical research organization?

A

The organization that is contracted by the sponsor to conduct and monitor the trial

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19
Q

What are surrogate markers?

A

Endpoints or surrogate markers are used to monitor the pharmacodynamics and pharmacokinetics of the drug

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20
Q

What is the abstract?

A

Provides enough information about a study’s objective, size, and key findings. Like the summary.

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21
Q

What is the introduction?

A

Provides relevant background information
Answers the question why was the study performed?

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22
Q

What are the methods?

A

How the study was designed to be conducted

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23
Q

What are the results?

A

How the study turned out

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24
Q

What is the discussion/conclusions?

A

Where the findings are explained

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25
Q

Three steps to turn study obstacles into opportunities to sell?

A

1.) closely examine your clinical study.
2.) anticipate questions.
3.) handle objections

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26
Q

Abstract concept

A

The starting point for measurement, its best understood as a general idea in linguistic form that helps us describe reality

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27
Q

Association

A

Immeasurable change in one variable that occurs concurrently with changes in another variable.

Positive association is change in the same direction

Negative association is concurrent changes in opposite directions

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28
Q

Constant

A

A constant is an attribute of a concept that does not vary

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29
Q

What is construct validity?

A

Defines how well a test or experiment measures up to it claims

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30
Q

What is content validity?

A

Extend to which a test adequately represents the subject matter content or behavior to be measured

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31
Q

What is a continuous variable?

A

This is a measure that can take on any value within a given interval, or set of intervals.

32
Q

Dependent variable

A

The value of the dependent variable depends on variations in another variable

33
Q

Discrete variable

A

This is a measure that is represented by a limited number of values

34
Q

Face validity

A

This evaluates whether the indicator appears to measure the abstract concept

35
Q

Independent variable

A

Variable that is manipulated to affect variations or responses in another variable

36
Q

Interval data

A

Variables that classify objects, according to type and logical order but also require that differences between levels of a category are equal

37
Q

Nominal data

A

Variables that classify objects, according to type or characteristic

38
Q

Operationalize

A

To create a measure of an abstract concept

39
Q

Ordinal data

A

Variables that classify objects, according to type or kind, but also have some logical order

40
Q

Predictive validity

A

This is the ability of an indicator to correctly predict an outcome

41
Q

Random variable

A

Any variable with a potential value that is influenced by chance

42
Q

Ratio data

A

These variables have a zero starting point and classify objects according to type and logical order, but also require that differences between levels of a category be equal

43
Q

Reliability

A

The consistency or repeatability of your measurements

44
Q

Spurious association

A

An association between two variables that can be better explained by or depends greatly on a third variable

45
Q

Statistical inference

A

The process whereby one reaches a conclusion about a population on the basis of information obtained from a sample drawn from that population

46
Q

Validity

A

Extent to which a measurement is an accurate representation of the concepts

47
Q

Variable

A

A measure of a concept that can take on more than one value from one observation to the next

48
Q

Biostatistics

A

A contraction of biology and statistics

49
Q

Clinical statistics

A

Assesses the effects of clinical variables on the diagnosis and treatment of human diseases and disorders.

50
Q

Epidemiology

A

The study of how factors influence disease and health in human populations

51
Q

Bioinformatics

A

A broad area of research concerned with the analysis of biological data on a molecular level

52
Q

Clinical trial experiment

A

Study in which the exposure status is determined by the investigator

53
Q

Randomized controlled trial (RCT)

A

A special type of clinical trials, in which assignment to an exposure is determined by sophisticated randomization methods

54
Q

Longitudinal cohort study

A

Observational study in which subjects with an exposure of interest and subjects, without the exposure are identified, and then followed forward in time to determine outcomes

55
Q

Case control study

A

Observational study that first identifies a group of subjects with a certain disease and a control group without the disease, and then looks to back in time to find exposure to risk factors for the disease.

Good for studying rare diseases

56
Q

Cross-sectional study

A

Observational study that is done to examine presence or absence of disease or exposure at a particular “snapshot” in time.

57
Q

Case report or case series

A

Descriptive study that reports on a single or series of patients with a certain disease

58
Q

Bias

A

Any systematic error in the design or conduct of a study that results in a mistaken estimate of an exposure’s effect on disease risk.

59
Q

Selection bias

A

Bias introduced by the way, in which participants are chosen for a study

60
Q

Confounding

A

This occurs when an investigator falsely concludes that a particular exposure is casually related to a disease without adjusting for other factors that are known risk factors for the disease and are associated with the exposure

61
Q

Mean

A

The sum of observed values divided by the number of observations

62
Q

Median

A

The observation that ranks in the middle when all observations are ordered from smallest to largest

63
Q

Mode

A

The most frequently occurring value among all observations

64
Q

Percentile

A

The percentage of a distribution that is below a specific value

65
Q

Interquartile range

A

Refers to the upper and lower boundary defining the middle 50% of observations. Upper is 75th percentile and lower is 25th percentile

66
Q

Spread (or variability)

A

Describes the manner in which data are scattered around a specific value

67
Q

Range

A

The difference between the largest observation and the smallest

68
Q

Standard deviation

A

Measures the spread of data around the mean

69
Q

Standard error of the mean

A

Describes the variability of the population mean that is measured in several different samples

70
Q

Incidence

A

The number of new events that occur during a specified period of time in a population at risk for developing the events

71
Q

Incidence rate

A

The number of new events that occur over the sum of time individuals in the population were at risk for having the event

72
Q

Prevalence

A

The number of persons in the population affected by a disease at a specific time, divided by the number of persons in the population at the time

73
Q

Measures of association

A

The types of measures used to defined the association between exposes and outcome

74
Q

Relative risk and cohort studies

A

The relative risk (or risk ratio) is defined as the ratio of the incidence of disease in the exposed group divided by the corresponding incidence of disease in the unexposed group.

75
Q

Odds ratio and case-control studies

A

The odds ratio is defined as the odds of exposure in the group with disease, divided by the odds of exposure in the control group

76
Q

Absolute risk

A

The relative risk and odds ratio provide a measure of risk compared with a standard

CNPR: Pharmaceutical Sales Training Manual - Revised 17th Edition (11 decks)

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