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CPPS 337 > Midterm > Flashcards

Midterm Flashcards

1
Q

Describe the drug development process in canada

A
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2
Q

4 phases of clinical trials

A

Phase 1: first in-human to evaluate safety and PK/PD
Phase 2: Exploratory, safety and efficacy in individuals with the disease
Phase 3: Confirmational, confirm safety and efficacy on larger scale
Phase 4: monitor safety and efficacy once the drug is on market

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3
Q

Pharmacokinetics vs pharmacodynamics

A

Pharmacokinetics (ADME)
how our body works on the drug
Absorption
Distribution
Metabolism
Excretion

Pharmacodynamics
how the drug works on our body
Mechanism of drug action
Relationship between drug concentration and effect
Adverse reactions

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4
Q

Approvals needed before initiation of clinical trials and who to get it from

A

Certificate of approval- USask Research Ethics Board
Letter of authorization- Sask health authority
No Objection Letter- Health Canada

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5
Q

When is a CTA required

A

Clinical trial application
Clinical trials of a product that is not authorized for sale in Canada
Clinical trials for marketed drugs where the proposed use of the drug is outside the parameters of the Notice of Compliance (NOC) or Drug Identification Number (DIN) application.

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6
Q

All experiments begin with a _________

A

question

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7
Q

What are outcomes

A

Specific assessments designed to help inform a given study objective

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8
Q

The success of the study will be based on results from _______

A

the primary outcome

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9
Q

Describe the steps in creating clinical trials

A

Question–>Objectives and outcomes–> Primary outcome–> Enrollment–> Randomization–> Allocation concealment–> Blinding –>Control groups –> Finding control group –> placebo controls

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10
Q

Two criteria of enrollment

A

Inclusion and exclusion criteria

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11
Q

How is randomization accomplished

A

Stratification

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12
Q

What is allocation concealment

A

How well you can conceal which group the patient has been randomized to

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13
Q

What are adequate procedures to ensure blinding

A

should have a matching control, control and intervention should be identical in appearance

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14
Q

What are some complications with blinding

A

Hard to do when comparing different techniques. Such as injectable vs oral.
Solution: patients who get ablet get placebo injection and vice versa

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15
Q

what group is essential to the scientific process

A

parallel control group

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16
Q

4 different options for control groups

A

Placebo
No treatment
Usual care/ standard of care
active treatment

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17
Q

what is the default control group for any RCT

A

placebo control

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18
Q

Quasi vs true experiment

A

Quasi: non-random assigning, pre-existing groups that got treatment after the fact, controls are not mandatory
True: Randomly assigned, Treatment designed by the researcher, control is mandatory

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19
Q

What is a prospective study

A

Almost all clinical trials are prospective
Looks forward
Watches for outcomes such as development of a disease

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20
Q

What is a retrospective study

A

Looks backwards
Examines past exposure to suspected risk of protection factors in relation to an outcome that is established at the start of the study

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21
Q

When would we use a historical control? What is a historical control

A

When there is no active control or placebo is unethical or when investigators think all patients should get intervention because it is so good
Outcomes compared to a group of patients retrieved from a database

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22
Q

why not use a historical control

A

Results are highly dependent on choice of control
subject to considerate bias

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23
Q

Crossover design

A

In a crossover trial, all of the participants in the trial will be exposed to all of the interventions/controls used in the trial
The advantage of a crossover design is that patients (in theory) serve as their own control
And…patients are able to experience both treatments

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24
Q

Does order matter in crossover design

A

yes

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25
Q

When should crossover design be used

A

Diseases that are chronic and stable
Treatments should not result in total cures, but should alleviate the disease

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26
Q

Withdrawal studies

A

Participants on a particular treatment (e.g., for a chronic disease) are taken off therapy or have the dosage reduced
Objective is to assess response to discontinuation or dose reduction
This design may be used to evaluate duration of benefit of an intervention already known to be useful

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27
Q

Cohort study

A

Observational
Participants (a cohort) are selected and information is obtained to determine which participants either have: Particular characteristics related to the disease or have been exposed to something that may cause disease
Participants are then followed in time and the incidence of the disease of those exposed is compared to the incidence to those who were not exposed

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28
Q

What kind of study was the framingham

A

Cohort
A cohort was selected from the city of Framingham, Mass. and followed for decades, tracking cardiovascular outcomes
Data from this trial has been used for years to calculate risk scores for CV disease
And the study is still ongoing…

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29
Q

Advantages and disadvantages of cohort studies

A

Advantages: Ability to study multiple outcomes for a given exposure
Good for investigating rare exposures
Can calculate rates of disease in exposed and unexposed individuals over time

Disadvantages: Large numbers of subjects are required to study rare exposures
Prospective Cohort Studies:
May be expensive
May require long durations for follow-up
Maintaining follow-up may be difficult
Susceptible to loss to follow-up or withdrawals
Retrospective Cohort Studies:
Susceptible to selection bias
Susceptible to recall bias
Less control over what information is available

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30
Q

Case-control study

A

compares patients who have a disease or outcome of interest (cases) with Patients who do not have the disease or outcome (controls)
Look back retrospectively to compare how frequently the exposure to a risk factor is present in each group to determine the relationship between the risk factor and the disease.

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31
Q

Case-control vs cohort studies

A

Unlike cohort studies, case-control studies identify subjects by outcome status at the outset of the investigation.
Selecting the appropriate group of controls can be one of the most demanding aspects of a case-control study (e.g., should be from same source population).
Individual matching may be used, whereby each case is individually paired with a control subject with respect to the background variables (e.g., age, sex

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32
Q

advantages and disadvantages of case-control studies

A

Advantages: Relatively quick to conduct
When a condition is uncommon can produce a lot of information from relatively few subjects
Relatively inexpensive
Existing records can be used

Disadvantages: Susceptible to recall bias
Difficult to validate information
Selection of an appropriate control group may be difficult
Individual matching can be time-consuming and expensive

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33
Q

Case series

A

Case series are a group or series of case reports involving patients who were given similar treatment.
Reports of case series usually contain detailed information about the individual patients.
This includes demographic information (for example, age, gender, ethnic origin) and information on diagnosis, treatment, response to treatment, and follow-up after treatment.
Size can range from two or three cases to hundreds or even thousands.

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34
Q

Advantages and disadvantages of case series

A

Advantage: can provide important initial indication of treatment efficacy, can describe the natural history of a condition or the recovery and complication rates after a treatment
Disadvantage: no control group

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35
Q

Characteristics of a good case series

A

Clearly defined question
Well-described study population
Well-described intervention
Use of validated outcome measures
Appropriate statistical analyses
Well-described results
Discussion/conclusions supported by data
Funding source acknowledged

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36
Q

Why are clinical trials important

A

Well designed and conducted clinical trials yield reliable results and help ensure participant safety.
Poorly designed clinical trials waste resources and have the potential to put participant’s safety at risk.

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37
Q

principles of GCP are designed to:

A

Be flexible and apply to a broad range of trials
Encourage consideration and planning
Be considerate of the factors relevant to ensuring a trials quality

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38
Q

What are the 3 regulatory bodies

A

Therapeutic products directorate
Biologics and genetic therapies directorate
Natural and non-prescription health products directorate

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39
Q

what does TPD, BGTD, and NNHPD regulate

A

Therapeutic Products Directorate (TPD) ensures that the pharmaceutical drugs and medical devices offered for sale in Canada are safe, effective and of high quality
The Biologics and Genetics Therapies Directorate (BGTD) ensures that the biological or radiopharmaceutical drug and medical device combinations offered for sale in Canada are safe, effective and of high quality
Natural and Non-prescription Health Products Directorate (NNHPD) falls under the Natural Health Products Regulations of the Food and Drugs Act. These Regulations came into effect on January 1, 2004

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40
Q

what is a nutraceutical

A

a product isolated or purified from foods that is generally sold in medicinal forms not usually associated with food”

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41
Q

What is a research ethics board

A

an independent committee made up of medical and non-medical professionals, such as scientists, physicians and community advocates, that serves to ensure that a clinical trial is ethical

42
Q

When is a REB required

A

a) research involving living human participants
b) research involving human biological materials, embryos, fetuses, fetal tissue, reproductive materials, and stem cells. Derived from living and deceased individuals

43
Q

When is research exempted from REB review

A
  1. REB review is not required when it relies exclusively on information that is in the public domain
  2. Observation of people in public places
  3. research relying exclusively on secondary use of anonymous information or anonymous human biological materials
  4. Quality assurance and quality improvement studies
  5. Creative practice activities
44
Q

Three core principles

A

Respect for persons
Concern for welfare
justice

45
Q

What is respect for persons

A

Autonomy: ability to make their own decision, being well informed
Protection of individuals with developing, impaired or diminished autonomy: researchers must seek consent from an authorized third party

Consent is the key aspect of the “respect for persons” core principle
Participant autonomy and informed consent

46
Q

What is concern for welfare

A

Welfare of a person: quality of a persons life
Determinants of welfare: Housing, employment, security, family life
Concern for welfare: Concern for privacy, for minimizing harm

Minimizing risk/harm

47
Q

what is justice

A

Participants must be treated fairly, equal distribution of research benefits as well as burden, Awareness of participant vulnerabilities, recruitment based on inclusion/ exclusion criteria

Inclusion/exclusion of participants, equitable distributions of risk and reward

48
Q

T/F Consent is an ongoing process

A

true

49
Q

8 requirements of consent

A
  1. freely given by participant or proxy if they lack the capacity
  2. Easily understandable
  3. on-going
  4. Precede data collection
  5. No undue influence or coercion
  6. Incentives cannot be coercive (not enough money to cloud judgment)
  7. If participant lacks the capacity to decide, they need to get an authorized third party
  8. consent must be documented
50
Q

When can consent be waived in research (4 reasons)

A

No more than minimal risk
Could not be carried out otherwise
If the waiver will not adversely affect the subjects
Subjects will be provided with additional information

51
Q

When can consent be waived in individual medical emergencies (5 reasons)

A

Needs immediate intervention
No standard effective treatment, or research offers direct benefit when compared to standard care
Participant is unconscious or lacks capacity
Authorization by a third party cannot be secured in time

52
Q

What was TGN1412

A

Humanized monoclonal antibody originally intended to treat leukemia and rheumatoid arthritis.
showed no evidence of toxicity in non-human primates
Every patient that received it developed severe allergy-like reactions resulting in hospitalization
This resulted in a cytokine storm
failed to uphold the respect for persons because patients were not well-informed

53
Q

4 lessons learned from TGN 1412

A

animal data doesn’t always predict human response
Guidelines for phase I clinical trials were revised to improve safety
A rigorous, fair and transparent consent process is of the utmost importance
Incentivization must not unduly influence the decision-making of the patient

54
Q

What must an acceptable plan for monitoring safety include

A

how participant safety will be monitored
What actions will be taken in the event that the safety of a participant is compromised
How the efficacy of the intervention will be monitored
What action swill be taken if the efficacy is greater than expected
Criteria by which participants may be removed
Study-wide stopping rules

55
Q

Study-wide stopping rules identify when a study should cease due to evidence that (3 things)

A

A condition is more or less efficacious
A conditions is more or less safe
The study is futile: data is unreliable

56
Q

What is MTD, MABEL, and NOAEL

A

MTD: maximum tolerated dose, highest dose that does not cause unacceptable side effects
MABEL: Minimal anticipated biological effect level, lowest animal dose required to produce pharmacological activity
NOAEL: Non-observed adverse effects level, highest dose at which there is no observed adverse effect in animal

57
Q

What were the 4 things wrong with TGN1412

A

Did not sufficiently inform participants
failed to disclose the degree of uncertainty
Coercive financial incentive
Participants were not well educated on the nature of the study or mechanism

58
Q

What were the ethical issues of BIA 10-2474

A

Physicians continued running a trial after a participant was sent to the hospital
Participants were not informed of the acute symptoms of the hospitalized patient
Physicians did not wait to determine the full scope of the adverse effects of the hospitalized participant.
respect for persons and concern for welfare were violated

59
Q

What are the goals and chief concern of phase I clinical trial

A

Phase 1: is the treatment safe, estimates safety and tolerability and establish the recommended dose for phase II trials.
Concerns: little to no experience regarding the drug and its effects, combination of clinical risk and uncertain benefit raises concern

60
Q

Goal and chief concern of phase II clinical trial

A

Goal: does the treatment work, determines if there is an effect in a small number of volunteers
Concerns: Participants may be financially impacted by their health condition which may be coercive, Circumstances may affects the patient’s perception of risk and rewards

61
Q

Goal and chief concern of phase III clinical trial

A

Goal: is it better than the current standard therapeutics, effectiveness and safety are compared to current standard
Concern: Care of patients should not be compromised by the assignment to an experimental group, drug may provide additional benefit relative to the standard options so patients should continue to receive adequate treatment following the study

62
Q

Goal and chief concern of phase IV clinical trial

A

Goal: Effectiveness and long-term safety are monitored over a large number of participants
concern: Trials should be undertaken for true scientific purposes without external motivations, sponsors pay a per capita fee which may sway investigators

63
Q

Why was BIA 10-2474 important

A

highlighted importance of consent and stopping rules

64
Q

what is the ISO definition of quality

A

Degree to which a set of inherent characteristics fulfills requirements

65
Q

definition of quality of care

A

the degree to which health services for individuals and populations increase the likelihood of a desired health outcome

66
Q

Definition of medical error

A

failure of a planned action to be completed as intended or the use of wrong plan to achieve an aim

67
Q

definition of an adverse event

A

an undesired outcome resulting from medical management rather than underlying condition of the patient

68
Q

Definition of patient safety

A

freedom from accidental injury

69
Q

what is the magnitutde of health care

A

44,000-98,000 hospital deaths in the US per year
Canada: one in eight affected by an adverse event
Human errors will occur between 1/1000 and 1/5000 events, and this will increase in stressful situations

70
Q

What are system errors

A

flaws in the systems and processes that contribute to most mistakes

71
Q

what is the swiss cheese model of accidents

A

When the different slices of swiss cheese incidentally line up, it will lead to an accident even though it is improbable

72
Q

what is the blunt and sharp end model

A

The blunt end refers to the many layers of the health care system not in direct contact with patients, but which influence the personnel and equipment at the sharp end that come into contact with patients.

73
Q

common lab medicine errors

A

sample collection, handling/storage
sample preparation
misinterpretation
interference
instrumentation
communication
inter oberver variability

74
Q

What stage do most errors happen in clinical laboratories

A

pre-analytical

75
Q

Laboratory-clinical interface errors

A

Inappropriate test request
Inappropriate test interpretation
inappropriate test utilization

76
Q

What is disclosure

A

A part of informed consent that enhances patient decision making
Open communication with patient about error is not seen as common practice

77
Q

consequences of the failure to disclose

A

Broken trust
ethical challenge
financial factor

78
Q

General considerations in laboratory stydies in disease

A

S ubjective
O bjective
A ssesment
P lan

79
Q

how should clinicians think of tests

A

as components of a strategy for solving patient’s problems

80
Q

Serum vs plasma

A

presence of fibrinogen in plasma
no delay is necessary in obtaining plasma prior to centrifugation
Usually a greater volume of plasma than serum

81
Q

types of tests

A

Physiological function
markers
Screening

82
Q

lab testing definitions of precision vs accuracy

A

Precision: reproducibility of replicate anlysis
Accuracy- relationship of result obtained to correct or try value

83
Q

inter-individual biologic variability

A

race, gender, age, body size

84
Q

Intra-individual biologic variability

A

Diurnal variation
circadian
menstrual cycle
seasonal
aging

85
Q

Preanalytic causes of variability

A

Food intake
exercise
drug therapy

86
Q

analytical and postanalytical causes of variability

A

analyticial: inaccuracy, imprecision
post-analytical: transcription errors

87
Q

sensitivity, specificity, prevalence, positive predictive value, negative predictive value

A

sensitivity: frequency of correct result in patient with disease
specificity: frequency of correct result in health patient
Prevalence: frequency of disease in total subjects examined
+ value: percent of positive results that are positive
- value: percent of negatives that are true negatives

88
Q

how to calculate sensitivity, specificity, positive predictive value and negative predictive value

A

Sensitivity= TP/(TP +FN) x 100, True positive/ all sick subjects
Specificity= TN/(TN + FP) x 100, True neg/ all disease free
+= TP/(TP+FP) x 100
-= TN/(TN+FN) x 100

89
Q

explain the steps invoovled in ordering clinical tests and list 5 potential errors that may occur

A

MD writes order: inappropriate test, Handwriting not legible, request on wrong form, wrong patient ID
Nurse reviews
Clerk writes requisition: form lost or delayed, wrong plate used
Lab prepares tube
Phlebotomist draws blood: wrong patient, sample hemolysis, inadequate volume, tourniquet on too long, blood diluted with IV fluid, wrong time
Specimen collection, transport and storage

90
Q

four commonly used collection tube types

A

Red: no additive/ may contain serum separator, used for general biochemistry
Dark blue: No additive/ used for serum, for trace metal analysis, general biochemistry
Dark Brown: Heparin added, for trace metal in whole blood (zinc, cadmium, lead), general biochemistry
Green top: Heparin added, 0.2mg/ml, antithrombin preventing clotting, general biochemistry

91
Q

what is evidence based clinical medicine

A

A set of procedures, pre-appraised resources and information tools to assist practitioners to apply evidence from research in the care of individual patients
a combination of individual expertise, best external evidence, and patient values. Application of best evidence and clinical expertise to make the best decisions regarding a patient’s care while respecting their values.

92
Q

problem with the traditional approach

A

only as good as the expert, may be affect be biases
clinical: dramatic experiences may influence the practice patterns

93
Q

Three components of EBCM

A

Individual’s expertise, best external evidence, patient values and expectations

94
Q

how is evidence based lab medicine different from evidence based clinical medicine

A

lab: integration of basic science, technical performance and clinical need for patient decision making. EBLM involves population based data to define clinical assay performance for an individual patient. Using the current best evidence in making well-informed decisions
EBCM focuses on treatment and intervention
EBLM focuses on gathering information for making well-informed decisions

95
Q

three components of EBLM

A

Individual expertise, best evidence, patient decision

96
Q

clinicians expectations from a biomarker/test

A

Define a disease and potentially reflect on the underlying etiology that can be targeted for therapy

97
Q

how to structure a question

A

population, intervention, comparison, outcome

98
Q

Steps in the EBM process (6)

A
  1. start with the patient, a clinical problem will arise
  2. the question, construct a question
  3. The Resource, select resources and conduct a search
  4. The evaluation, Appraise the evidence for validity and usefulness
  5. The Patietn, return to patient and integrate evidence with clinical expertise
  6. Self-evaluation, evaluate your performance with the patient
99
Q

What is EBLM

A

Evidence based laboratory medicine integrates into clinical decion-making the best available research evidence for the use of laboratory tests or procedures with clinical expertise and experience of the physician, and the needs, expectations and concerns of the patient, in order to improve the outcome of patients

100
Q

5 components of a clinical trial

A

Objective
Enrollment
Randomization
Blinding
Control groups

CPPS 337 (5 decks)

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