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EBM > Block 2 lect 1 > Flashcards

Block 2 lect 1 Flashcards

1
Q

Why do we conduct research ?

A

To answer the descriptive
[who, what, when, where]

analytical questions
[why, how]

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2
Q

What is a drug ?

A

-a product intended for use in DX, CURE, TX, PREVENTION of a disease

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3
Q

the drug discovery process :

A

-new insight into a disease state

-new tech
-testing compounds
-unanticipated effects
-eventually a product arises

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4
Q

6 major sources of drug products:

A

-semi synthetic (penicillin)
-recombinant DNA tech
-Plant sources (digoxin)
-animal sources (premarin)
-minerals/earth sources
microbiological sources

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5
Q

Stage 1: Drug Product Discovery

A

-focuses on target tissues and compounds

-LAB SCREENING (3-6 yrs)

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6
Q

Stage 2: Pre-clinical Studies

A

-determine TOXICITY/ SAFETY

in vitro and in vivo

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7
Q

In Vivo testing consists of:

A

test drugs ON LIVING ANIMALS : 2 mammals and 2 administrations routes

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8
Q

In Vitro:

A

performed outside of normal environment of cells

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9
Q

Investigational new drug application:

A

-drug sponsor/developer submits IND application BEFORE starting clinical research.

-request approval to give drug to humans
-FDA has 30 days to review the application

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10
Q

Stage 3- PHASE 1, Clinical Trails

A

-healthy volunteers or
-with dx/ condition who failed conventional tx

-no control group
-focused on safety, tolerability, toxicity

-70% move on to phase 2

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11
Q

stage 3, Phase II Clinical Trials

A

-ppl w/ disease of interest
-placebo group
-focuses on efficacy
-short term side effects

[ideal and controlled conditions]

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12
Q

efficacy

A

-power to produce a desired result or effect

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13
Q

Stage 3, Phase III Clinical Trials

A

-ppl w/ disease if interest
-focuses on efficacy AND effectiveness
-most time consuming phase

(superiority over inferiority)

-drug achieves health result under “real world” conditions

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14
Q

effectiveness

A

-producing a result that is wanted and have an intended effect

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15
Q

Vaccine Efficacy:

A

vaccine will reduce risk of infection by irrespective of transmission setting

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16
Q

New Drug Application Process:

A

-gets through phase III clinical trials
-all trial are complete
-must demonstrate benefits» risks

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17
Q

Stage 3, Phase IV Clinical Trials

A

-long-term data from post marketing surveillance

-MONITOR safety and efficacy
(look into rare side effects)

-pharmacovigilance

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18
Q

Clinical Trial Phase 1

A

-toxicity/ tolerability
-healthy volunteers with disease or failure of tx
-unblinded, uncontrolled
<100

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19
Q

Clinical Trial Phase 2

A

-efficacy and safety
-subjects with target disease
RCT
1-2 yrs
>100

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20
Q

Clinical Trial phase III

A

-efficacy, effectiveness, and safety
-subjects with target disease
RCT
-several years

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21
Q

Clinical Trail phase IV

A

-long term data
-target disease and additional disease

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22
Q

What is research design?

A

-plan that allows researchers to gather answers to study questions

-provide valid results: Internal vs external

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23
Q

Internal Validity:

A

degree which results of a study are correct to members od the source pop. (free from bias)

[quality of design]

-STATISTICALLy SIG?

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24
Q

External validity:

A

results are true to members outside source population (generalize)
[applicability to practice]

CLINICALLY SIG?

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25
Q

The 9 causation considerations:

A

-temporarily
-strength
-biological gradient
-consistency
-specificity
-plausibility
-coherence
-analogy
-experiment

26
Q

temporality:

A

cause must occur before the effect

27
Q

strength

A

plausibility inc. strength of relationship btw. variables

28
Q

biological gradient

A

linear relationship btw tx and clinical outcome

29
Q

consistency

A

cause and effect relationship observed across different settings

30
Q

specificity

A

A single cause for an effect

31
Q

plausibility

A

possibility for relationship btw casue and effect

32
Q

coherence

A

cause and effect consistent w existing knowledge

33
Q

analogy

A

phenomenon may show causation

34
Q

experiment

A

-cause can be manipulated, leading to changes in effect

35
Q

Experimental Designs:

A

researchers CONTROL one variable to see the other variable impact
[RCT]

36
Q

Observational Designs:

A

researcher OBSERVES two variables (case control)

37
Q

Prospective

A

-data collection after study
-determine variable and objective
[RCT, prosp. cohort}

38
Q

Retrospective

A

-evaluates past or existing data
-minimal resources
-rely in previous data

[case control, retrospective cohort]

39
Q

What are the two types of data classification:

A

-primary: data collected to answer a research question

-secondary: using data from previous collection

40
Q

Primary Data collection:

[Self reports]

A

-collects thoughts, perceptions, attitudes, behaviors

41
Q

Primary Data collection:

[observational]

A

-gather info activities, characteristics, comm., interaction

Obtrusive: participant aware is present

Unobtrusive: unaware, researcher hidden/ in disguise

42
Q

Primary Data collection:

[biological measure’t ]

A

-objective markers
-clinical lab testing

types:
biophysical (BP) , biochemical (chemical) , microbiological

43
Q

Measurement error-

-systemic error:

A

-measurement / observation is always off target in same direction [BIASED]

44
Q

Measurement error:

-Random error

A

-due to chance
(statistical adjustments)

45
Q

Systematic Error: aka bias

A

-changing variables that can alter true values.

-assessment bias
-threat to internal validity

46
Q

Types of Bias:

Selection Bias

A

-error method from researcher where they select subj. for study participation

Direct vs. indirect

47
Q

Types of Bias:

Information bias

A

-error occurs due to :

wrong info collect from pt, or not the same effort put into both groups

-different sources , data from previous records,

48
Q

Types of information bias:

recall
reporting

A

-recall: defects in memory

-reporting: one group reports more than the other (occurs in personal or sensitive)

49
Q

Types of Bias:

Confounding

A

-error that occurs when outcome of interest is influenced by outside factor

-mask assoc. or falsely demonstrate assoc.

50
Q

two ways to reduce systemic error:

A

-blind-masking
-randomization

51
Q

blind masking:

A
  • those involved in research are unaware of participant allocation

open label, single blind, double blind, triple blind

52
Q

open label

A

-no blinding; least objective

-all involved are aware

53
Q

single blind

A

-one of those involved is unaware tx

-participant is blinded

54
Q

double blind

A

-subj. and investigators are unaware of tx allocation

55
Q

triple blind

A

-MOST OBJ.
participants, investigators, and those resp. for monitoring data are blinded

56
Q

randomization:

A

-all participants have equal chance to be assigned to intervention or control

simple, block, stratified, adaptive

57
Q

Randomization:
Simple

A

-single sequence of random assignments

easy for larger sizes

58
Q

Randomization:
Block

A

-put subjects to test

-equal in size

59
Q

Randomization:
stratified

A

predefined strata based on what researchers find important

60
Q

Randomization:
adaptive

A

-modification of randomization

EBM (2 decks)

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